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ObjectivesTo define the instruments for the Assessment of SpondyloArthritis international Society–Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA).MethodsAn international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments’ psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS.ResultsThe updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments.ConclusionsThe selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials.

BackgroundSecukinumab efficacy and retention data are emerging in patients with axial spondyloarthritis (axSpA) in real-world settings. However, limited data are available on the predictive factors that affect the retention rate. The key objective was to determine whether objective signs of inflammation (OSI) were predictive of secukinumab retention at 1 year.MethodsFORSYA is a French, multicentric, non-interventional, retrospective study in adult axSpA patients who received secukinumab treatment between its launch (11 August 2016) and 31 August 2018. The time to secukinumab discontinuation and retention were analysed using a Kaplan-Meier (KM) analysis. OSI was predefined by at least one of the criteria: C reactive protein ≥5 mg/L or erythrocyte sedimentation rate ≥28 mm/hour at secukinumab initiation or MRI inflammation at the sacroiliac or spine level.ResultsIn total, 906 patients from 48 centres were included in the analysis, 42.2% of whom were men, with a mean age of 46.2±11.7 years and a mean disease duration of 9.3±9.1 years. The 1-year KM retention rate (95% CI) for secukinumab was 59% (55%–62%), whereas for patients with and without OSI, it was 58% (54%–62%) and 63% (53%–73%), respectively. In multivariate analysis, lack of prior exposure to tumour necrosis factor inhibitor (TNFi), absence of OSI and inflammatory bowel disease (IBD) were associated with a better retention of secukinumab at 1 year.ConclusionFollowing its approval in France, ~59% of axSpA patients retained secukinumab in daily practice, at 1 year. Prior exposure to TNFi, OSI and IBD were identified as risk factors for secukinumab discontinuation.

ObjectiveTo assess whether gut microbiota composition is associated with patient characteristics and may have predictive value on the response to TNF inhibitor (TNFi) treatment in axial spondyloarthritis (AxSpA).MethodsThe study involved 61 patients fulfilling the Assessment of SpondyloArthritis International Society classification criteria for AxSpA. All patients had active disease despite non-steroidal anti-inflammatory drugs intake and were eligible for treatment with a TNFi. At baseline, the mean Ankylosing Spondylitis Disease Activity Score was 2.9±1 and mean C reactive protein (CRP) level 9.7±11.4 mg/L. Bacterial 16S ribosomal RNA gene sequencing was performed on stool samples collected at baseline (month 0 (M0)) and 3 months after TNFi initiation (month 3 (M3)). Alpha and beta diversity metrics were calculated on the relative abundance of core operational taxonomic units (OTUs).ResultsThe HLA-B27 status affected at least in part the global composition of faecal microbiota at M0 as well as the abundance/prevalence of several anaerobic bacteria in the familiesOscillospiraceae,LachnospiraceaeandBifidobacteriaceae. In contrast, smoking affected the global composition of faecal microbiota at both M0 and M3. The prevalence/abundance of seven bacterial OTUs at M0 was associated with response to TNFi treatment. One of the candidates, present only in non-responders, is the genusSutterella, and the other six candidates are in the classClostridia.ConclusionsSeveral SpA patients’ characteristics modulate the composition of gut microbiota as did TNFi treatment. Moreover, the abundance/prevalence of seven OTUs at baseline may be used as a novel non-invasive index that predicts the response to TNFi with greater accuracy than HLA-B27 status, CRP level and measures of disease activity.

Background and aimStriving for harmonisation of specialty training and excellence of care in rheumatology, the European League Against Rheumatism (EULAR) established a task force to develop points to consider (PtCs) for the assessment of competences during rheumatology specialty training.MethodsA systematic literature review on the performance of methods for the assessment of competences in rheumatology specialty training was conducted. This was followed by focus groups in five selected countries to gather information on assessment practices and priorities. Combining the collected evidence with expert opinion, the PtCs were formulated by the multidisciplinary task force, including rheumatologists, medical educationalists, and people with rheumatic and musculoskeletal diseases. The level of agreement (LoA) for each PtC was anonymously voted online.ResultsFour overarching principles and 10 PtCs were formulated. The overarching principles highlighted the importance of assessments being closely linked to the rheumatology training programme and protecting sufficient time and resources to ensure effective implementation. In the PtCs, two were related to overall assessment strategy (PtCs 1 and 5); three focused on formative assessment and portfolio (PtCs 2–4); three focused on the assessment of knowledge, skills or professionalism (PtCs 6–8); one focused on trainees at risk of failure (PtC 9); and one focused on training the trainers (PtC 10). The LoA (0–10) ranged from 8.75 to 9.9.ConclusionThese EULAR PtCs provide European guidance on assessment methods throughout rheumatology training programmes. These can be used to benchmark current practices and to develop future strategies, thereby fostering continuous improvement in rheumatology learning and, ultimately, in patient care.

ObjectivesTo provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field.MethodsAn international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items.ResultsThe task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high.ConclusionsThese updated EULAR recommendations provide consensus on the management of RA with respect to benefit, safety, preferences and cost.

ObjectivesTo investigate the influence of gender on disease outcomes in patients with spondyloarthritis (SpA), including across SpA subtypes.MethodsData from 4185 patients of 23 countries with a diagnosis of axial SpA (axSpA), peripheral SpA (pSpA) or psoriatic arthritis (PsA) from the Assessment of SpondyloArthritis International Society (ASAS)-perSpA study were analysed. Associations between gender and disease activity (Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Score (BASDAI), C-reactive protein (CRP)), function (Bath Ankylosing Spondylitis Functional Index (BASFI)) and overall health (ASAS Health Index (ASAS HI), European Quality of Life Five Dimension (EQ-5D)) outcomes were investigated. Multilevel multivariable linear mixed models adjusted for relevant confounders (and stratified by disease subtype in case of a relevant interaction) were used.ResultsIn total, 65%, 10% and 25% of patients had axSpA, pSpA and PsA, respectively. axSpA was more frequent in males (68%), whereas pSpA and PsA were more frequent in females (53% and 52%, respectively). A significant interaction between gender and disease subtype was found for ASDAS, BASDAI and BASFI. While being female independently contributed to higher BASDAI across the three disease subtypes (with varying magnitude), female gender was only associated with higher ASDAS in pSpA (β (95% CI): 0.36 (0.15 to 0.58)) and PsA (0.25 (0.12 to 0.38)) but not in axSpA (0.016 (−0.07 to 0.11)). No associations were observed between gender and CRP levels. Female gender was associated with higher ASAS HI and EQ-5D, without differences across disease subtype.ConclusionFemale gender is associated with less favourable outcome measures across the SpA spectrum. However, while female gender influences BASDAI across the three subtypes, ASDAS is associated with gender only in pSpA and PsA but not in axSpA. Therefore, ASDAS is an appropriate instrument both for females and males with axSpA.

ObjectivesTo compare the clinical manifestations, disease activity and disease burden between patients with radiographic (r-axSpA) and non-radiographic axial spondyloarthritis (nr-axSpA) over a 5-year follow-up period in the Devenir des Spondylarthropathies Indifferénciées Récentes (DESIR) cohort.MethodsPatients from the DESIR cohort who had X-ray images of the sacroiliac joints available at baseline and did not leave the study during the 5-year follow-up period because of a diagnosis other than axSpA were included. A unilateral rating of ‘obvious sacroiliitis’ by the local reader was considered sufficient for classification as r-axSpA. The incidence of first episodes of peripheral and extra-rheumatic manifestations was compared between the two groups using the incidence rate ratio and Cox regressions adjusted for sex, age and tumour necrosis factor blocker (TNFb) intake. Mean values of patient-reported outcomes (PROs) and days of sick leave over 5 years of follow-up were compared using mixed models adjusted for sex, age, TNFb intake and baseline values.ResultsIn total, 669 patients were included, of whom 185 (27.7%) and 484 (72.3%) were classified as r-axSpA and nr-axSpA, respectively. At baseline, the r-axSpA patients showed a significantly higher prevalence of males. After adjusting for age, sex and TNFb intake, Cox regressions for peripheral and extra-rheumatic manifestations did not show any significant differences between groups. Mixed models also showed similar mean levels in PROs and days of sick leave between groups over time.ConclusionThe incidence of peripheral and extra-rheumatic manifestations as well as the disease burden over time remained similar between r-axSpA and nr-axSpA groups after adjusting for intermediate variables.Trial registration numberNCT01648907

To update the European League Against Rheumatism (EULAR) recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) published in 2011. Four systematic literature reviews were performed regarding the incidence/prevalence of vaccine-preventable infections among patients with AIIRD; efficacy, immunogenicity and safety of vaccines; effect of anti-rheumatic drugs on the response to vaccines; effect of vaccination of household of AIIRDs patients. Subsequently, recommendations were formulated based on the evidence and expert opinion. The updated recommendations comprise six overarching principles and nine recommendations. The former address the need for an annual vaccination status assessment, shared decision-making and timing of vaccination, favouring vaccination during quiescent disease, preferably prior to the initiation of immunosuppression. Non-live vaccines can be safely provided to AIIRD patients regardless of underlying therapy, whereas live-attenuated vaccines may be considered with caution. Influenza and pneumococcal vaccination should be strongly considered for the majority of patients with AIIRD. Tetanus toxoid and human papilloma virus vaccination should be provided to AIIRD patients as recommended for the general population. Hepatitis A, hepatitis B and herpes zoster vaccination should be administered to AIIRD patients at risk. Immunocompetent household members of patients with AIIRD should receive vaccines according to national guidelines, except for the oral poliomyelitis vaccine. Live-attenuated vaccines should be avoided during the first 6 months of life in newborns of mothers treated with biologics during the second half of pregnancy. These 2019 EULAR recommendations provide an up-to-date guidance on the management of vaccinations in patients with AIIRD.

Some studies have showed that obesity, as determined by a body mass index (BMI) ≥30 kg/m2, hampers treatment response to tumour necrosis factor-alpha blockers (TNFb) in patients with axial spondyloarthritis (axSpA).1 However, no study has specifically determined the impact of abdominal adiposity as assessed by waist circumference (WC), on treatment response to TNFb in early axSpA. As compared with BMI, WC is more strongly associated with the metabolic disturbances thought to underlie many of the obesity‐related conditions. Notably, it is associated with low-grade inflammation and all-cause and cardiovascular mortality with or without adjustment for BMI.2 Therefore, we hypothesise that WC could be also an independent factor for TNF b response. We conducted an analysis to assess the impact of abdominal adiposity on the treatment effect of TNFb in real life in an early axSpA population. Devenir des Spondylarthropathies Indifferenciees Recentes cohort3 is a multicenter, observational, prospective cohort of 708 patients with early (

ObjectiveThis study aimed to assess the impact of disease-modifying antirheumatic drugs (DMARDs) on 10-year outcomes in rheumatoid arthritis (RA).MethodsPatients with RA from the ESPOIR cohort with complete data on Disease Activity Score in 28 Joints (DAS28) and Health Assessment Questionnaire (HAQ) at 10 years (n=418) and complete radiographic data at baseline and 10 years (n=343) were included in this study. Outcomes were favourable outcome (FavOut) at 10 years, defined as DAS28 of ResultsOverall, 196/418 (46.9%) patients showed FavOut and 252/343 (73.5%) AbsSDP. WCE models had the best predictive performance, with area under the curve=0.80 (95% CI 0.74 to 0.87) for FavOut and 0.87 (95% CI 0.83 to 0.92) for AbsSDP. In the WCE model, the odds of FavOut and AbsSDP were reduced with conventional synthetic disease-modifying antirheumatic drug (csDMARD) initiation at 12 months versus at baseline (OR 0.78, 95% CI 0.65 to 0.94, and OR 0.89, 95% CI 0.76 to 0.98, respectively). Early biologics initiation was not significantly associated with either outcome.ConclusionsWCE models can identify and quantify the long-term benefit of early csDMARD initiation on 10-year functional and structural outcomes in patients with RA.

ObjectivesTo estimate the frequency of reporting composite indices evaluating axial spondyloarthritis (axSpA) disease activity in daily practice and to assess its impact on the secukinumab (SEC) retention rate.MethodsStudy design: Retrospective, multicentre. Data collected: (1) Recommended composite indices: Bath Ankylosing Spondyltitis Disease Activity Index (BASDAI) +C reactive protein or Ankylosing Spondylitis Disease Activity Score (ASDAS) at the time of initiation of SEC and at least once during the first year of follow-up; (2) Drug retention rate: percentage of patients still on SEC over time according to whether at least one recommended composite index had been optimally reported.ResultsA recommended composite index has been collected in 22% of the 906 enrolled axSpA patients. The percentage of patients still on treatment after 1, 2 and 3 years of follow-up was greater in those for whom at least one composite index had been optimally reported (respectively, 64% (57–71) vs 57% (54–61), 55% (48–62) vs 41% (38–45) and 52% (44–59) vs 38% (34–42), log rank test, p=0.016) with a lower risk of SEC discontinuation for these patients (HR: 0.70 (95% CI 0.5 to 0.88), Cox model, p=0.003).ConclusionThis study suggests that reporting of recommended composites indices for monitoring axSpA might be associated with higher retention rates of biological therapies.

ObjectivesJanus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety.MethodsExisting data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration.ResultsThe Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale.ConclusionThe consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management.

ObjectiveTo evaluate long-term effectiveness of tumour necrosis factor inhibitor (TNFi) after a first switch, and their associated factors in an early axial spondyloarthritis (axSpA) population, considering time-varying prescription bias.MethodsObservational prospective cohort (DEvenir des Spondylarthropathies Indifférenciées Récentes) with 5 years of follow-up, including 708 TNFi-naïve patients with early axSpA. Long-term effectiveness of TNFi after a first switch (ASAS40 response after at least 2 visits under treatment) were estimated using marginal structural models (implementing inverse-probability weighting and iterative propensity scores). Factors associated with the outcome were explored by multivariate Cox regression models.ResultsThe hazard to present an ASAS40 response after a first TNFi switch was increased (HR=2.4 (95% CI 1.9 to 3.0)); this response ratio was slightly lower compared with the response in TNFi naïve patients after a first TNFi (HR=3.3 (95% CI 2.9 to 3.8)). HLA-B27 positive was the only factor independently associated with ASAS40 response after a first TNFi switch.ConclusionAfter application of innovative methods to overcome time-varying prescription bias, the magnitude of the TNFi response after a first switch was found to be numerically lower but clinically relevant from the response in TNFi-naïve patients.

ObjectivesAn increased risk of vertebral fractures (VFs) has been reported in spondyloarthritis (SpA). Our hypothesis is that the prevalence of VFs is lower than reported in previous studies, especially in early SpA. This study aimed at assessing the incidence of radiographical VFs over 5 years in early axial SpA.MethodsThe DESIR (DEvenir des Spondylarthropathies Indifférenciées Récentes) cohort, which included patients with inflammatory back pain highly suggestive of axial SpA, is the basis of this study. All radiographs of the DESIR cohort had been assessed at a central facility, by one investigator specialised in the field of the diagnosis of VFs according to Genant’s method. We assessed the prevalence and incidence of VFs and vertebral deformities at baseline and over 5 years.ResultsFive-year X-rays were available for 432 patients (mean age 34.3±8.7 years, 53% women). Diagnosis of VF was doubtful and needed adjudication for 19 patients (4.4%). 13 patients had prevalent VFs (3.0%) which were located at the thoracic spine (12 were grade 1). At 5 years, five patients had an incident VF (1.15%); seven vertebrae were fractured, mostly located at the thoracic spine (n=6/7), and of grade 1 (n=6/7).ConclusionIn the DESIR cohort, a population of early SpA, we found a low prevalence and incidence of VFs (3.0% and 1.15 %), respectively. This confirms our hypothesis that the actual prevalence and incidence of VFvertebral fracture in SpA is lower than that reported in the previous studies.

ObjectivesThe value of biological disease-modifying antirheumatic drugs (bDMARDs) in spondyloarthritis (SpA) is well recognised, but global access to these treatments can be limited due to high costs and other factors. This study explores country variation in the use of bDMARDs in SpA in relation to country-level socioeconomic factors.MethodsPatients fulfilling the Assessment in SpondyloArthritis International Society (ASAS) SpA criteria in the multinational, cross-sectional ASAS Comorbidities in Spondyloarthritis study were studied. Current use of bDMARDs or conventional synthetic DMARDs (csDMARDs) was investigated in separate models, with multilevel logistic regression analysis, taking the country level into account. Contribution of socioeconomic factors, including country health expenditures, gross domestic product and human development index as independent country-level factors, was explored individually, in models adjusted for sociodemographic as well as clinical variables.ResultsIn total, 3370 patients from 22 countries were included (mean (SD) age 43 (14) years; 66% male; 88% axial disease). Across countries, 1275 (38%) patients were bDMARD users. Crude mean bDMARD use varied between 5% (China) to 74% (Belgium). After adjustment for relevant sociodemographic and clinical variables, important variation in bDMARD use across countries remained (PConclusionsThere remains important residual variation across countries in bDMARD uptake of patients with SpA followed in specialised SpA centres. This is independent of well-known factors for bDMARD use such as clinical and country-level socioeconomic factors.

Background:ESPOIR is a longitudinal prospective cohort of adults with possible early RA (ClinicalTrials.gov: NCT03666091). Patients were referred by rheumatologists and general practitioners to one of the 14 regional centers in France. The objective and design of the cohort are described elsewhere (1). Patients received standard of care by their rheumatologists and were followed without predefined therapeutic strategiesObjectives:To report the current 10-year outcome of patients with early rheumatoid arthritis (RA) in the ESPOIR cohort, and predictors of outcome.Methods:From 2003 to 2005, 813 patients were included if they had early arthritis (< 6 months) with a high probability of RA developing and had never been prescribed disease modifying anti-rheumatic drugs (DMARDs). Multivariate logistic regression analysis was used to evaluate predictors of outcome.Results:In total, 521 (64.1%) RA patients were followed up for 10 years and 35 (4.3%) died, which appears similar to the French general population. Overall, 480 (92.1%) patients received a DMARD; 174/521 (33.4%) received at least one biologic DMARD, 13.6 and 23.4% within 2 and 5 years. At year 10 (Table), mean DAS28 ESR was 2.5 ± 1.3; 273 (52.4%) patients were in DAS28 remission, 39.7% in CDAI remission, 40.1% in DAS28 sustained remission, and 14.1% in drug-free remission. Disability was well controlled overtime (Figure) and half of the patients achieved a HAQ Disability Index < 0.5; the SF-36 physical component and pain were well controlled. Structural progression was weak, with a mean change from baseline in modified Sharp score of 11.0 ± 17.9. A total of 82 (16.5%) patients required joint surgery including arthroplasty or arthrodesis in only 6.5% of the cases. A substantial number of patients showed new comorbidities, mainly cardiovascular or metabolic diseases over 10 years. Finally, positivity for anti-citrullinated protein antibodies was confirmed as a robust predictor of long-term outcome in patients with early RA.Table 1.Outcome in ESPOIR cohort and 1993 cohort at 10 yearsESPOIR cohort n=5211993 cohort n=112DAS28 ESR2.5 ± 1.3DAS44-2.2 ± 0.9SDAI7.5 ± 8.7CDAI6.8 ±8.3DAS28 ESR remission (n (%)273 (52.4)CDAI remission207 (39.7)DAS28 sustained remission, n (%)209 (40.1)DAS28 drug-free remission, n (%)75 (14.1)DAS28 ESR LDA336 (64.5)Rheumatoid nodules39 (7.5)Sicca syndrome314 (60.3)Patient global assessment24.0 ± 24.0HAQ DI score0.5 ± 0.60.75 ± 0.71HAQ DI < 0.5, n (%)280 (54.5)SF36 MCS46.7 ± 10.5SF36 PCS44.6 ± 9.2Pain (mm, VAS)16.6 ± 20.6Fatigue (mm, VAS)31.4 ± 27.023.2 ± 23.0ESR (mm/hr)14.4 ± 13.818.4 ± 16.5CRP level (mg/l)6.4 ± 16.59.3 ± 11.7Normal CRP (< 5 mg/l), n (%)336 (67.6)Total mSharp score*13.8 ± 19.635.4 ± 46.1Erosion score4.9 ± 9.418.4 ± 26.5)Joint narrowing score8.9 ± 12.132.1 ±23.2Joint surgery82 (16.5)26 (23.2)Joint arthroplasty/arthrodesis34 (6.5)20 (17.9)Data are mean (SD)DAS28, disease activity in 28 joints; HAQ DI, Health Assessment Questionnaire Disability Index; SF36 MCS, Medial Outcomes Study 36-item Short Form mental component summary; SF36 PCS, Medical Outcomes Study 36-item Short Form physical component summary; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein; VAS, visual analog scale; CDAI, Clinical Disease Activity Index; SDAI, Simple Disease Activity Index; *van der Heijde-modified Total Sharp scoreFigure 1.Health Assessment Questionnaire Disability Index (HAQ-DI) over 10 years Data are mean (SD).Conclusion:We report a very mild 10-year outcome of a large inception cohort of patients with early RA diagnosed in the early 2000s, which was much better than results for a previous cohort of early RA patients who were recruited in 1993. This current favourable outcome may be related to more intensive care for real-life patients than previously.References:[1]Combe B et al. Jt Bone Spine Rev Rhum. 2007;74:440–5Acknowledgements:We thank MC Boissier, G Falgaronne and F. Lioté for help in patient recruitment. An unrestricted grant from Merck Sharp and Dohme (MSD) was allocated for the first 5 years of the cohort study. Two additional grants from INSERM supported part of the biological database. The French Society of Rheumatology, Abbvie, Pfizer, Lilly and more recently Fresenius and Biogen supported the ESPOIR cohort.Disclosure of Interests:Bernard Combe Speakers bureau: AbbVie; BMS; Gilead; Lilly; Merck; Pfizer; Roche-Chugai;, Consultant of: AbbVie; BMS; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi;, Grant/research support from: Fresenius, Novartis, Pfizer, and Roche-Chugai., Nathalie Rincheval: None declared, Francis Berenbaum Speakers bureau: Boehringer, Bone Therapeutics, Expanscience, Galapagos, Gilead, GSK, Merck Sereno, MSD, Nordic, Novartis, Regulaxis, Roche, Sandoz, Sanofi, Servier, UCB, Peptinov, TRB Chemedica, 4Moving Biotech, 4P Pharma, Consultant of: Boehringer, Bone Therapeutics, Expanscience, Galapagos, Gilead, GSK, Merck Sereno, MSD, Nordic, Novartis, Regulaxis, Roche, Sandoz, Sanofi, Servier, UCB, Peptinov, TRB Chemedica, 4Moving Biotech, 4P Pharma, Patrick BOUMIER: None declared, Alain Cantagrel Speakers bureau: AbbVie; Amgen, Bristol-Myers Squibb; Grunenthal; Lilly; Medac; MSD France; Novartis; Pfizer; Roche-Chugai; Sanofi;, Consultant of: AbbVie; Amgen, Bristol-Myers Squibb; Grunenthal; Lilly; Medac; MSD France; Novartis; Pfizer; Roche-Chugai; Sanofi;, Grant/research support from: Abbvie, Fresenius, MSD France, Novartis, Pfizer, and UCB, Philippe Dieudé Speakers bureau: Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Lilly, Medac, Novartis Roche-Genentech, Sanofi, Consultant of: Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Lilly, Medac, Novartis Roche-Genentech, Sanofi, Grant/research support from: Bristol-Myers Squibb, GlaxoSmithKline, Pfizer., Maxime Dougados Speakers bureau: Pfizer, Abbvie, Lilly, UCB, Merck, BMS, Roche, Biogen, Sanofi, Novartis, and Sandoz, Consultant of: Pfizer, Abbvie, Lilly, UCB, Merck, BMS, Roche, Biogen, Sanofi, Novartis, and Sandoz, Grant/research support from: Pfizer, Abbvie, Lilly, UCB, Merck, BMS, Roche, Biogen, Sanofi, Novartis, and Sandoz, Bruno Fautrel Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Fresenius Kabi, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Fresenius Kabi, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Grant/research support from: AbbVie, Lilly, MSD and Pfizer, René-Marc Flipo Speakers bureau: Abbvie, Biogen, BMS, Janssen, MSD, Nordic, Novartis, Pfizer, Roche-Chugai and Sanofi-Genzyme, Consultant of: Abbvie, Biogen, BMS, Janssen, MSD, Nordic, Novartis, Pfizer, Roche-Chugai and Sanofi-Genzyme, Grant/research support from: Abbvie, Janssen, Novartis, Pfizer and Roche-Chugai, Philippe Goupille Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB., Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB., Grant/research support from: Abbvie, Biogen, MSD, Pfizer, Xavier Mariette Speakers bureau: BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Servier, and UCB., Consultant of: BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Servier, and UCB., Grant/research support from: Servier, Alain Saraux Speakers bureau: AbbVie, Bristol-Myers Squibb, Lilly, Nordic, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Lilly, Nordic, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB, Grant/research support from: Roche-Chugai, Thierry Schaeverbeke Speakers bureau: AbbVie, BMS, Lilly, Novartis, Nordic Pharma, Pfizer, Roche, UCB, Consultant of: AbbVie, BMS, Lilly, Novartis, Nordic Pharma, Pfizer, Roche, UCB, Grant/research support from: Pfizer, AbbVie, BMS, Roche, UCB, Astra, MSD, Rigel, AB-sciences, Jean Sibilia Speakers bureau: AbbVie, Lilly, MSD, Amgen, Pfizer, BMS, Janssen, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Novartis., Consultant of: AbbVie, Lilly, MSD, Amgen, Pfizer, BMS, Janssen, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Novartis., Grant/research support from: AbbVie, Lilly, Pfizer, Roche, Olivier VITTECOQ Speakers bureau: AbbVie, Bristol-Myers Squibb, Gilead, Lilly, Merck, Novartis, Pfizer; Roche-Chugai, Mylan and Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Gilead, Lilly, Merck, Novartis, Pfizer; Roche-Chugai, Mylan and Sanofi, Grant/research support from: Novartis, Pfizer, Merck, and Bristol-Myers Squibb, Jean-Pierre Daures: None declared

Background:Health outcomes in spondyloarthritis (SpA) are largely determined by socioeconomic (SE) factors, leading to the great inequity observed between countries across the world. However, the impact of these SE factors on health outcomes across the different SpA phenotypes (axSpA, pSpA and PsA), is less well known.Objectives:To investigate (1) the association between individual and country-level SE factors and health outcomes in different SpA phenotypes, and (2) to explore whether any effect of these SE factors is mediated by the use of b/tsDMARD therapy.Methods:Patients with axSpA, pSpA or PsA from the multinational cohort ASAS-perSpA were included in the analysis. The effect of individual (age, gender, education and marital status) and country-level SE factors (Gross Domestic Product [GDP], Healthcare Expenditure [HCE], Human Development Index [HDI], Gini Index) over health outcomes (ASDAS≥2.1, continuous ASDAS, BASFI, fatigue and ASAS-HI) were assessed in multivariable mixed-effects logistic and linear regression models (as appropriate), adjusting for confounders. Interactions between each individual and country-level SE factors and disease phenotype and between both levels of SE factors, were tested. Finally, a mediation analysis was conducted to explore whether the impact of country-level SE factors on ASDAS is mediated through b/tsDMARD uptake.Results:A total of 4185 patients from 23 countries were included: 61% males, mean age 45 (SD 14), 65% axSpA, 10% pSpA and 25% PsA. Female gender, lower educational level and marital status (single vs married) were associated with higher ASDAS, without significant differences across disease phenotype. Living in lower-(vs higher) GDP countries was also associated with higher ASDAS (β=0.39 [95%CI 0.16; 0.63], with similar results for other economic indicators (Figure 1). 7% of the association between GDP and ASDAS was mediated by b/tsDMARD uptake. The above-mentioned individual and country-level SE factors remained significant to discriminate active disease (ASDAS≥2.1), with greater impact of gender (OR=1.32 [1.13; 1.54]), educational level (primary vs university OR=1.76 [1.40;2.20]) and lower GDP (OR= 1.74 [1.22;2.46]). Higher BASFI was also associated with gender (female vs male: β=0.12 [0.01; 0.24]), lower education (primary vs university: β=0.29 [0.11; 0.46], and marital status (single vs married: β=0.23 [0.09; 0.38]), without effect of country-level SE factors, and no differences across SpA phenotype. Gender and lower educational level were similarly associated with worse ASAS-HI scores (female vs male β=0.88 [0.68;1.09], and primary vs university β=0.61 [0.31;0.91]), while more fatigue was only associated with female gender and, in an opposite direction, with higher country-level SE factors (Figure 1). No interactions were found between individual and country-level SE factors for any of the outcomes.Conclusion:Individual (female gender and lower education) and country-level SE factors are independently associated with higher disease activity in SpA. Uptake of b/tsDMARD had a small mediating effect on the association between GDP and ASDAS. Lower education and female gender are also associated with worse outcomes of functional disability, global functioning and fatigue. Country-level SE factors are not associated with functional disability or global functioning; in contrast, there is a paradoxical effect with fatigue: living in a country with a higher SE status is independently associated with higher levels of fatigue. Management of disease outcome in SpA requires also awareness of the role of individual and country level SE-factors.Figure 1.Effect of individual and country-level socioeconomic factors on ASDAS and fatigue, derived from multivariable mixed-effects models adjusted by clinical confounders.Disclosure of Interests:Dafne Capelusnik Speakers bureau: BMS, Grant/research support from: Pfizer, Sizheng Steven Zhao: None declared, Annelies Boonen: None declared, Nelly Ziade Speakers bureau: Roche, Abbvie, Eli Lilly, Pfizer, Janssen, Novartis, Pierre Fabre, Apotex, Pharmaline, Paid instructor for: Abbvie, Eli Lilly, Sanofi-Aventis, Pfizer, Janssen, Consultant of: Roche, Abbvie, Eli Lilly, Pfizer, Janssen, Novartis, Gilead, NewBridge, Grant/research support from: Abbvie, NewBridge, Algorithm/Celgene, Clementina López-Medina: None declared, Maxime Dougados: None declared, Elena Nikiphorou Speakers bureau: Pfizer, Lilly, AbbVie, Sofia Ramiro Speakers bureau: Lilly, MSD, Novartis, UCB, Consultant of: AbbVie, Lilly, MSD, Novartis, UCB, Sanofi, Grant/research support from: MSD

Background:Heterogeneity in psoriatic arthritis (PsA) is a current matter of discussion, especially concerning axial involvement.Objectives:To determine the profile of axial PsA (axPsA) in a worldwide setting. Secondly, to identify predictive factors associated with the development of axial involvement in patients with PsA.Methods:Data from 3684 patients with axial spondyloarthritis (axSpA) or PsA from the ASAS-PerSpA study were analysed. The ASAS-PerSpA is an observational, cross-sectional study that recruited consecutive patients with SpA from 68 centers worldwide. For this analysis, 367 PsA patients ever presenting axial involvement according to their rheumatologist were defined as axPsA and compared with 2651 axSpA patients, using logistic regression to later identify predictive factors for rheumatologist diagnosis of axPsA. In addition, the axPsA patients were also compared with 666 PsA patients without axial involvement (pPsA) and the characteristics associated with axial manifestations were determined by logistic regression analysis.Results:Among all patients, 2651 were identified as axSpA and 1033 patients as PsA. Among those with axial involvement, 2651 were identified as axSpA (100% of axSpA) and 367 as axPsA (35.5 % of PsA). In comparison with axSpA, axPsA patients were less frequently males, older, less frequently HLA-B27 positive and had a higher body mass index (Table 1). Additionally, while patients with axPsA had more peripheral manifestations and psoriasis, concomitant IBD and uveitis were higher in axSpA. In the multivariable analysis, older age at diagnosis (OR= 1.04), peripheral arthritis (OR= 7.32) and dactylitis (OR= 2.82) were significantly associated with a diagnosis of axPsA. However, uveitis (OR= 0.22), IBD (OR= 0.12) or HLA*B27 carriership (OR= 0.26) were inversely associated with axPsA diagnosis as compared to axSpA. Furthermore, axial involvement in patients with PsA was significantly associated with male gender (OR= 1.68), elevated CRP (OR= 2.87), and the absence of psoriasis (OR= 0.33).Conclusion:In this worldwide setting, axPsA was defined by rheumatologists as a unique phenotype, with disease features lying between axSpA and pure pPsA. Male gender, elevated CRP and the absence of psoriasis were associated with axial involvement in patients with PsA.Table 1.Demographic and disease characteristics of patients with axial involvement included in the ASAS PerSpA study. Results shown as absolute numbers (percentages) or as the mean ± standard deviationaxSpAn= 2651axPsAn= 367p-valueSex (male)1816 (68.5) 196 (53.4)Age at study visit42.1(13.0)50.0 (12.7)Body Mass Index25.9 (5.1)27.4 (5.7)Family history of SpA944 (35.6)135 (36.8)0.684Past history or current symptoms of back pain2625 (99.0)358 (97.5)0.04Inflammatory back pain (ASAS definition), n/N(%)2500/2632 (94.9)317/362 (87.6)Sacroiliitis on imaging, n/N (%) by: xRay mNY criteria1997/2586 (77.2)185/298 (62.1) MRI-SIJ, ASAS definition1449/1757 (82.4)141/225 (62.6) mNY criteria or ASAS definition2446/2634 (92.9)243/339 (71.7)HLA B27 positive1674 /2126 (78.7)54/182 (29.6)Elevated CRP (>5 mg/dL)1863/2569 (72.5)274/356 (76.9)0.2Classification criteria ASAS criteria2339 (88.2)185 (50.4) CASPAR criteria123 (4.6)274 (74.4)Peripheral Arthritis946 (35.7)318 (86.6)Enthesitis1086 (41.0)198 (54.0)Dactylitis155 (5.8)125 (34.1)Psoriasis185 (7.0)324 (88.3)IBD129 (4.9)3 (0.8)Uveitis576(21.7)13 (3.5)csDMARD (ever)1359 (51.3)339 (92.4)bDMARD (ever)1585 (59.8)263 (71.7)Specific drug for axial involvementNSAIDs2465 (98.6)317 (96.1)0.002csDMARD828 (33.1)187 (56.7)bDMARD1288 (51.5)180 (54.4)0.32axSpA: axial spondyloarthritis; axPsA: axial psoriatic arthritis; IBD: Inflammatory Bowel Disease; CRP: C-Reactive Protein; mNY: modified New York; csDMARDs: conventional synthetic DMARDs; bDMARDs: biological DMARDs; NSAID: Non-steroidal anti-inflammatory drugsDisclosure of Interests:Diego Benavent: None declared, Chamaida Plasencia: None declared, Denis Poddubnyy: None declared, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma., Fabian Proft Grant/research support from: AbbVie, AMGEN, BMS, Celgene, MSD, Novartis, Pfizer, Roche, UCB, Haruki Sawada: None declared, Clementina López-Medina: None declared, Maxime Dougados: None declared, Victoria Navarro-Compán: None declared.

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim safety and efficacy of BKZ in patients with active AS from a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its ongoing open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Treatment-emergent adverse events (TEAEs) are reported for the BE AGILE safety set (patients who received ≥1 dose of BKZ on study entry) for total exposure to BKZ across BE AGILE and the OLE. Efficacy outcomes are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: ASAS40, ASAS20, ASAS PR, ASDAS, ASDAS-CII, ASDAS-MI, ASDAS-ID (Results:262/303 (86%) patients randomised at BE AGILE study baseline completed Week 48 on BKZ 160 mg or 320 mg. At Week 48, 255/262 (97%) patients entered the OLE (full analysis set: 254); 219 patients had an efficacy assessment at Week 156. Over the 156 weeks, the exposure-adjusted incidence rate (EAIR) per 100 patient-years (PY) of TEAEs was 143.5, with an EAIR of 5.8 for serious TEAEs, 1.3 for serious infections, and 3.8 for Candida infections (Table 1). All Candida infections were mild or moderate; none were systemic or led to study discontinuation. Over 156 weeks, the EAIR of inflammatory bowel disease (1.2), anterior uveitis (0.8), and injection site reactions (0.5) remained low. Efficacy demonstrated at Week 48 in BE AGILE was maintained or improved up to Week 156 (Figure 1). Mean ASDAS improved from 3.9 at BE AGILE baseline to 2.0 and 1.8 at Weeks 48 and 156 respectively (by MI). At Week 156 in the NRI analyses, ASAS40 and ASAS PR were achieved by 62.6% (OC: 72.6%) and 32.7% (OC: 37.9%) patients respectively. ASDAS-ID and ASDAS Table 1.Safety for total exposure to BKZ across BE AGILE and the OLEBE AGILEWeeks 0–48BE AGILE + OLEWeeks 0–156n (%) [EAIR/100 PY]BKZ 160 mg(n=149;114.2 PY)BKZ 320 mg(n=150;119.6 PY)All BKZ(N=303;261.3 PY)All BKZ(N=303;781.0 PY)Any TEAE103 (69.1) [168.7]122 (81.3) [221.1]235 (77.6) [186.2]280 (92.4) [143.5]Serious TEAEs5 (3.4) [4.4]6 (4.0) [5.1]13 (4.3) [5.1]43 (14.2) [5.8]Key TEAEs of special monitoringSerious infections3 (2.0) [2.7]1 (0.7) [0.8]4 (1.3) [1.5]10 (3.3) [1.3]Candida infections10 (6.7) [9.1]9 (6.0) [7.9]19 (6.3) [7.5]28 (9.2) [3.8]Inflammatory bowel disease1 (0.7) [0.9]2 (1.3) [1.7]4 (1.3) [1.5]9 (3.0) [1.2]Anterior uveitis1 (0.7) [0.9]1 (0.7) [0.8]2 (0.7) [0.8]6 (2.0) [0.8]Study discontinuations due to TEAEs7 (4.7)10 (6.7)20 (6.6)38 (12.5)Drug-related TEAEs48 (32.2)54 (36.0)110 (36.3)149 (49.2)Deaths1 (0.7)01 (0.3)2 (0.7)TEAEs are reported for the BE AGILE safety set for total exposure to BKZ across BE AGILE and the OLE. There was one death in BE AGILE (cardiac arrest) and one in the OLE (road traffic accident); neither was considered treatment-related.Conclusion:The safety profile of BKZ in patients with AS was in line with previous observations.1.2 Patients treated with BKZ demonstrated sustained and consistent efficacy over 156 weeks.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604; 2. Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma, Employee of: Director of Imaging Rheumatology, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma, Lianne S. Gensler Consultant of: AbbVie, Eli Lilly, Gilead, GSK, Novartis, Pfizer, UCB Pharma, Grant/research support from: Pfizer, Denis Poddubnyy Speakers bureau: AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, Novartis, Pfizer, Samsung Bioepis, UCB Pharma, Grant/research support from: AbbVie, MSD, Novartis, Pfizer, Alan Kivitz Shareholder of: Pfizer, Novartis, Speakers bureau: Amgen, Eli Lilly, Pfizer, Novartis, Consultant of: Novartis, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma

ObjectiveTo describe the prevalence of fibromyalgia (FM) in an axial spondyloarthritis (axSpA) population and to confirm that concomitant FM had a negative impact on tumour necrosis factor blockers’ (TNFb) response.DesignProspective observational study with two visits 3 months apart.PatientsAdult patients with AxSpa initiating a TNFb.Study groupsFM was defined by the Fibromyalgia Rapid Screening Tool (FiRST) at baseline and also by a sustained positive FiRST (both visits) and by a fulfilment of the 1990 American College of Rheumatology criteria for FM.Statistical analysisPrevalence of FM; evaluation of the impact of a concomitant FM on TNFb response (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) as primary endpoint), adjusted by factors known to have an impact on TNFb response.ResultsAmong the 508 patients included in the main analysis, 192 (37.8%) were screened at baseline as FM. Percentage of success after 12 weeks of treatment was lower in the FM group for most of the effectiveness endpoints (eg, BASDAI 50: 45.3% vs 54.1% in the FM/not FM groups according to the FiRST), except for the C reactive protein change endpoints which were not different across groups.ConclusionThis study confirms that FM coexists in patients with axSpA and that its presence seems to have a negative impact on TNFb response, which seems more related to the self-reported instruments used in its evaluation, rather than a different treatment effect of the molecule in this subgroup of patients.

ObjectiveTo evaluate the impact on structural lesions observed on MRI in the sacroiliac joints (SIJ) at 12 weeks in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving etanercept or placebo in EMBARK (Effect of Etanercept on Symptoms and Objective Inflammation in nr-axSpA, a 104 week study).MethodsPatients were randomised to double-blind etanercept 50 mg/week or placebo for 12 weeks. Structural lesions at baseline and 12 weeks were scored by two independent readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score (SSS) on T1-weighted MRI. Change in SPARCC SSS and correlation with improvement in clinical outcomes was evaluated.ResultsMRI scans from 185 patients (etanercept, n=88; placebo, n=97) were reviewed. At baseline, there were no significant differences in mean SPARCC SSS between etanercept and placebo. From baseline to 12 weeks, change in mean SPARCC SSS was significantly greater for etanercept than placebo for erosion (–0.57 vs –0.08, respectively, adjusted p value=0.017) and backfill (0.36 vs 0.06, adjusted p value=0.022). A treatment difference was also present for the subgroup of patients with SIJ inflammation on MRI (SPARCC bone marrow oedema ≥2): erosion: –0.81 versus –0.13 for etanercept versus placebo, respectively, p=0.007; backfill: 0.48 versus 0.08, respectively, p=0.032. Decrease in erosion and increase in backfill correlated with improvement in more clinical outcomes for etanercept than placebo.ConclusionTreatment with etanercept was associated with significantly greater reduction in erosions and increase in backfill at 12 weeks compared with placebo, consistent with a very early reparative response to antitumour necrosis factor therapy. The impact on disease progression in spondyloarthritis should be studied further.Trial registration numberNCT01258738; Post-results.

Background: In 2010 the latest ASAS-EULAR recommendations for ankylosing spondylitis and the ASAS recommendations for the use of TNF-inhibitors (TNFi) have been published. Since then new treatments for axial Spondyloarthritis (axSpA) have become available. Aim: To update and integrate the two sets[for full text, please go to the a.m. URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Background:Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in reducing pain and stiffness in ankylosing spondylitis (AS) patients (pts).1However, continuous use of NSAIDs may lead to gastrointestinal, cardiovascular and renal toxicity.2Therefore, reduction in NSAID intake is desirable in AS pts.Objectives:To evaluate the long-term effect of secukinumab (SEC) on NSAID intake in AS pts pooled from the 3 SEC trials (MEASURE [M] 2-4).Methods:NSAID intake was evaluated prospectively using the Assessment of SpondyloArthritis International Society (ASAS)-NSAID score.3The score was determined by type of NSAID, daily dose, and weights from frequency of intake, as well as % of time use in period. An ASAS-NSAID score of ‘0’ indicates no NSAID intake. Pts with ASAS-NSAID score >0 at baseline (BL) were analysed. SEC dose groups were defined as Any 150 or 300 mg, as defined for pooled safety analyses for SEC. Pts with initial placebo treatment (up to 24 weeks) were included in their respective post-Week 24 SEC dose groups to analyse ASAS-NSAID score at Year (Y) 2 (M2-4), Y3 (M2-3) and Y4 (M2) from BL. From the ASAS-NSAID score at BL, the mean change in ASAS-NSAID score, proportion of pts achieving 50% reduction, and the proportion of pts with score Results:Overall, 562 pts (SEC: 150 mg, N=467; 300 mg, N=95) were analysed. The mean ASAS-NSAID score decreased with time in both dose groups. Greater improvements were observed in high NSAID users and with longer treatment exposure (Figure). Proportion of pts who achieved 50% reduction in ASAS-NSAID score increased with time in both SEC 150 and 300 mg groups. Proportion of pts with clinically meaningful reduction of ASAS-NSAID score TableTime (years)NSAID intakeLow ()High (ASAS-NSAID ≥75)OverallSEC 150 mg(N=167)SEC 300 mg#(N=37)SEC 150 mg(N=300)SEC 300 mg#(N=58)SEC 150 mg(N=467)SEC 300 mg#(N=95)Proportion of pts who achieved 50% reduction from BL in ASAS-NSAID score, % (n/m)*225 (38/154)18 (6/33)19 (50/267)14 (7/49)21 (88/421)16 (13/82)323 (13/56)21 (7/33)26 (26/100)17 (8/46)25 (39/156)19 (15/79)429 (7/24)-26 (14/54)-27 (21/78)-Proportion of pts with ASAS-NSAID score % (n/m)*239 (60/154)33 (11/33)12 (33/267)12 (6/49)22 (93/421)21 (17/82)334 (19/56)33 (11/33)17 (17/100)13 (6/46)23 (36/156)22 (17/79)438 (9/24)-20 (11/54)-26 (20/78)-*Observed data.#MEASURE 3 that evaluated 300 mg was only a 3 year study. N, total number of pts in the group; n, number of pts with response; m, number of evaluable ptsConclusion:SEC provided sustained improvement in ASAS-NSAID score in AS pts and was associated with clinically relevant NSAID-sparing effect in AS pts, when used to measure NSAID intake up to 4 years of treatment. Overall, SEC provided long-term NSAID-sparing effects in both high and low NSAID users.References:[1]Molto A, et al.Joint Bone Spine. 2017;84:79–82.[2]Dougados M, et al.Arthritis Res & Ther. 2014;16:481.[3]Dougados M, et al.Ann Rheum Dis. 2011;70:249–51.Disclosure of Interests:Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Karel Pavelka Speakers bureau: AbbVie, BMS, MSD, UCB, Medac, Egis, Pfizer, Roche, Biogen, Novartis, Susanne Rohrer Employee of: Novartis, Suzanne McCreddin Shareholder of: Novartis, Employee of: Novartis, Erhard Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, Brian Porter Shareholder of: Novartis, Employee of: Novartis, Zsolts Talloczy Shareholder of: Novartis, Employee of: Novartis

Background:Patients with ankylosing spondylitis (AS) are burdened with decreased work productivity.1Ixekizumab (IXE), a high-affinity monoclonal antibody selectively targeting interleukin-17A, has been shown to improve disease signs and symptoms in 2 phase 3 trials assessing patients with active AS.2, 3Objectives:This study investigated the effect of IXE treatment for 52 weeks on work productivity and activity impairment as measured by absenteeism, presenteeism, overall work impairment, and activity impairment in patients with active AS.Methods:COAST-V (NCT02696785) and COAST-W (NCT02696798) were phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled (COAST-V active-controlled with adalimumab) trials investigating the efficacy of IXE every 4 weeks (Q4W) and every 2 weeks (Q2W) in 341 patients with active AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) and in 316 patients who were inadequate responders or intolerant to 1 or 2 tumor necrosis factor inhibitors (TNFi; COAST-W). Patients receiving PBO were switched to IXE Q4W or Q2W at Week 16; patients receiving adalimumab (ADA) were switched to IXE Q4W or Q2W at Week 20. Data for IXE Q4W and Q2W were combined for PBO/IXE and ADA/IXE groups. Changes from baseline in work productivity were measured for those reporting full- or part-time work at Weeks 16 and 52 with the Work Productivity and Activity Impairment (WPAI) Questionnaire for Spondyloarthritis.Results:Compared to bDMARD-naïve patients (COAST-V), TNFi-experienced patients (COAST-W) were slightly older, had longer disease duration, reported less paid employment, and had greater scores for impaired work productivity, signifying more severe baseline disease. At Week 16, bDMARD-naïve patients treated with IXE Q4W or Q2W had significant improvements in activity impairment compared to placebo (pConclusion:Both bDMARD-naïve and TNFi-experienced patients with AS receiving IXE had greater improvements in aspects of work productivity compared to placebo. Improvements were sustained through Week 52.References:[1]Boonen, van der Linden. (2006).J Rheumatol Suppl.78:4-11.[2]Van der Heijde, et al. (2018)Lancet. 392(10163):2441-51.[3]Deodhar, et al. (2019)Arthritis Rheumatol.71(4):599-611.Disclosure of Interests:Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer, Sun Pharma, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB Pharma, Proton Rahman Grant/research support from: Janssen and Novartis, Consultant of: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, and Pfizer., Speakers bureau: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, Pfizer, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, James Cheng-Chung Wei Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis, UCB Pharma, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Xiaoqi Li Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Baojin Zhu Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCBFigure.Changes from baseline in Overall Work Impairment in A) bDMARD-naïve (COAST-V) and B) TNFi-experienced (COAST-W) patients and Activity Impairment in C) bDMARD-naïve and D) TNFi-experienced patients.

Background:Current treatments for PsA have proven effective in reducing patient (pt)-reported pain;1,2however, residual pain often remains. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA.Objectives:This descriptive analysis evaluated the effect of tofacitinib, adalimumab and placebo on residual pain in pts with PsA whose inflammation was attenuated after 3 months of therapy.Methods:Data were included from OPAL Broaden (NCT01877668), a randomised, double-blind, placebo-controlled Phase 3 trial of 12 months’ duration in pts with PsA.3Pts were randomised to receive tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, adalimumab 40 mg subcutaneous injection once every 2 weeks or placebo. This analysis assessed pts with ‘residual pain’ at Month (M)3. Residual pain was considered as pain in pts with complete attenuation of inflammation at M3, defined by a swollen joint count (SJC) of 0 and CRP levels Results:Demographics and baseline disease characteristics have previously been reported in the primary study, and were generally similar between treatment groups.3At M3, 100/422 (23.7%) pts with PsA had achieved SJC of 0 and CRP Conclusion:Changes from baseline in pain and absolute pain at M3 suggest that in pts with PsA whose inflammation has been completely attenuated, tofacitinib might have an effect on residual pain not obviously attributable to inflammation. However, the sample population was small, and there were large standard deviations. To confirm these results and to understand the mechanisms by which tofacitinib may improve residual pain, a meta-analysis will be performed using individual participant data from pts with rheumatic disease who have participated in tofacitinib randomised controlled trials.References:[1]Gladman et al. Ann Rheum Dis 2007;66:163-68.[2]Gladman et al. Arthritis Care Res 2014;66:1085-92.[3]Mease et al. NEJM 2017;377:1537-50.Acknowledgments:Study sponsored by Pfizer Inc. Medical writing support was provided by Mark Bennett of CMC Connect and funded by Pfizer Inc.Disclosure of Interests:Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Peter C. Taylor Grant/research support from: Celgene, Eli Lilly and Company, Galapagos, and Gilead, Consultant of: AbbVie, Biogen, Eli Lilly and Company, Fresenius, Galapagos, Gilead, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer Roche, and UCB, Lara Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, John Woolcott Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Yves Brault Shareholder of: Pfizer France, Employee of: Pfizer France, Lisy Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Meriem Kessouri Shareholder of: Pfizer France, Employee of: Pfizer France

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively neutralises interleukin (IL)-17A and IL-17F, is a potential therapeutic option in ankylosing spondylitis (AS).Objectives:To report 48-week (wk) patient-reported outcomes (PROs) in patients (pts) with AS treated with BKZ in a phase 2b dose-ranging study (BE-AGILE;NCT02963506).Methods:Pts with active AS (Bath AS Disease Activity Index [BASDAI] ≥4; spinal pain ≥4 [0–10]), fulfilling modified New York criteria (central reading), and inadequate response/intolerance to NSAIDs were randomised according to the study design (Figure 1). PROs included spinal pain, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), Bath AS Functional Index (BASFI), Medical Outcomes Study (MOS) Sleep Problems Index II and AS Quality of Life questionnaire (ASQoL). Efficacy is reported for pts initially randomised to placebo (PBO) or BKZ 160/320 mg every 4 weeks (Q4W); treatment-emergent adverse events (TEAEs) are reported for pts who received ≥1 dose of study drug (Safety Set).Results:Of 303 pts, 181 were randomised to PBO or BKZ 160/320 Q4W mg at Wk 0; 179/181 completed Wk 12 and 161/181 completed Wk 48. At Wk 12, improvements in pain, fatigue, morning stiffness, BASFI, sleep and ASQoL were greater in BKZ pts vs PBO pts. Responses were further improved or maintained to Wk 48, with no meaningful differences between BKZ 160 mg and 320 mg (Table 1). Serious TEAEs occurred in 13/303 (4.3%) pts (Table 2), which included 2 major adverse cardiac events considered not related to study drug. Oral candidiasis occurred in 16 (5.3%) pts.Table 1.PRO efficacy endpoints to Week 48 (multiple imputation)Mean (SD)WkPBO – BKZ 160 mg(n=24)PBO – BKZ 320 mg(n=36)BKZ 160 mg(n=58)BKZ 320 mg(n=61)Spinal pain06.9 (1.4)7.0 (1.9)6.6 (2.0)7.3 (1.5)CfB12-1.5 (1.6)-0.7 (1.7)-2.6 (2.2)-3.6 (2.4)48-3.7 (2.0)-3.7 (2.6)-3.8 (2.4)-4.7 (2.1)Fatigue06.4 (1.7)6.8 (1.6)6.4 (1.7)6.4 (1.9)CfB12-0.7 (2.5)-1.0 (1.7)-2.1 (2.2)-2.1 (2.5)48-2.7 (2.2)-2.8 (2.4)-3.1 (2.1)-3.3 (2.4)Morning stiffness06.9 (1.7)6.7 (2.0)6.5 (1.8)6.6 (2.1)CfB12-1.5 (1.7)-1.1 (1.5)-2.8 (2.0)-3.4 (2.7)48-3.9 (2.2)-3.6 (2.4)-3.9 (2.2)-4.4 (2.4)BASFI05.8 (1.8)5.5 (2.2)5.5 (2.2)5.9 (2.0)CfB12-1.0 (2.1)-0.3 (1.7)-1.7 (1.8)-2.2 (2.0)48-2.9 (2.2)-2.4 (2.2)-2.5 (2.0)-2.9 (2.2)MOS Sleep Problems Index II045.5 (8.1)45.3 (7.9)46.9 (7.5)47.2 (9.4)CfB122.1 (8.3)1.8 (6.8)5.6 (6.7)6.8 (7.5)487.6 (8.7)8.0 (9.1)6.5 (6.1)8.0 (7.9)ASQoL08.4 (4.7)9.2 (4.7)8.4 (4.3)8.7 (4.3)CfB12-1.3 (5.5)-1.3 (3.7)-3.5 (4.3)-4.6 (4.8)48-4.2 (5.6)-5.3 (5.6)-4.9 (4.1)-5.4 (4.8)CfB: change from baselineTable 2.Overview of TEAEs to Week 48 (Safety Set; N=303)n (%)BKZ 160 mg(n=149)BKZ 320 mg(n=150)All BKZ [a](N=303)Any TEAE103 (69.1)122 (81.3)235 (77.6)Drug-related TEAEs48 (32.2)54 (36.0)110 (36.3)Serious TEAEs5 (3.4)6 (4.0)13 (4.3)Discontinuations due to TEAEs7 (4.7)10 (6.7)20 (6.6)[a] Includes TEAEs for 16 and 64 mg BKZConclusion:Pts with active AS demonstrated rapid and sustained improvements in PROs, sleep and quality of life over 48 wks of BKZ treatment. BKZ was generally well tolerated with no unexpected safety findings versus previous studies.Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim, Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Mary Katherine Farmer Employee of: UCB Pharma, Dominique Baeten Employee of: UCB Pharma, Nadine Goldammer Employee of: UCB Pharma, Jason Coarse Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

Background:In patients with spondyloarthritis (SpA), root joint diseases (RJD), i.e. hip or shoulder involvement, may be associated with a distinct disease phenotype compared to those with other affected joints. The ASAS-PerSpA study (PERipheral involvement in SPondyloArthritis) [1], offers a unique opportunity to study the phenotypes of patients with RJD in a global cohort.Objectives:Primary objective was to compare the clinical characteristics of SpA patients with and without RJD. Secondary objectives were to compare the prevalence of RJD across the different SpA subtypes and the different regions of the world, compare the severity of axial disease as well as the disease burden in SpA patients with and without RJD.Methods:This is a post-hoc analysis of the ASAS-PerSpA study, which included 4,465 patients with any subtype of SpA (axial SpA (axSpA), peripheral SpA (pSpA), psoriatic arthritis (PsA), inflammatory bowel disease associated SpA (IBD-SpA), reactive arthritis (ReA) and Juvenile SpA (Juv-SpA)) according to the rheumatologist’s diagnosis. RJD was defined as a positive answer by the investigator to the following question: “Do you consider that the patient has ever suffered from RJD (e.g. hip, shoulder) related to SpA?” In case of a positive answer, a potential specific treatment (e.g. Total Articular Replacement) was investigated. The patient’s characteristics were compared between those with and without RJD involvement, using Chi-2 or Fisher exact test for the categorical variables and t-test for the continuous variables. Two separate multivariable stepwise binary logistic regression analyses were conducted to identify factors associated with the dependent variables “hip involvement” and “shoulder involvement”.Results:RJD occurred in 1,503 patients (33.7%), with more prevalent hip (24.2%) than shoulder (13.2%) involvement. The prevalence of RJD as a group was the highest in Juv-SpA (52.7%), followed by pSpA (44.3%) and axSpA (33.9%). The highest prevalence of RJD was found in Asia and the lowest in Europe and North America. Among patients with hip involvement, 6.0% had a history of hip replacement (highest in the Middle East and North Africa and Latin America); among patients with shoulder involvement, 0.8% had a history of shoulder replacement. Hip had a distinct pattern of associations compared to shoulder involvement (Figure 1). Hip involvement was significantly associated with the SpA main diagnosis (highest in pSpA, lowest in PsA), younger age at first SpA symptom, lower prevalence of family history of psoriasis, positive HLA-B27, occiput-to-wall distance>0, and treatment with cs-DMARDs and b-DMARDs. Shoulder involvement was associated with the SpA main diagnosis (highest in Juv-SpA and pSpA, lowest in axSpA), older age at first SpA symptom, higher prevalence of enthesitis, dactylitis, tender joints count, IBD, occiput-to-wall distance>0, EQ5D score and treatment with cs-DMARDs.Conclusion:Hip involvement was more prevalent than shoulder involvement in patients with SpA, and had a distinct phenotype resembling axial disease whereas shoulder involvement was mostly associated with features of peripheral disease. Hip and shoulder involvement should be analyzed separately in future studies rather than under the RJD entity.References:[1]Lopez-medina, C. et al. Prevalence and Distribution of Peripheral Musculoskeletal Manifestations in Axial Spondyloarthritis, Peripheral Spondyloarthritis and Psoriatic Arthritis: Results of the International, Cross-sectional ASAS-PerSpA Study. RMD Open; 2021;7:e001450.Disclosure of Interests:None declared

Background:Enthesitis is a common feature of axial spondyloarthropathy (axSpA) and psoriatic arthritis (PsA). Up to 25% of individuals with axSpA and PsA have a co-existing diagnosis of fibromyalgia syndrome (FMS). The anatomic overlap between tender points in FMS and sites of entheses is a challenge when differentiating between active SpA and FMS. Literature investigating the co-existence of enthesitis and FMS in individuals with SpA is sparse, in particular the effect of sex. The ASAS Peripheral involvement in Spondyloarthritis (PerSpA) study aims to characterize peripheral musculoskeletal in individuals with SpA across the world.Objectives:(1)To characterise the co-existence of enthesitis and FMS in individuals with SpA.(2)To explore the effect of sex on the presence of FMS and enthesitis.Methods:All individuals from the cross-sectional multinational ASAS-PerSpA study with a diagnosis of axSpA, peripheral SpA (pSpA) or PsA according to their rheumatologist were included. The Fibromyalgia Rapid Screening Tool (FiRST) was used to make the diagnosis of FMS. The baseline descriptive and clinical differences between sexes were performed using T-tests and crosstabs. Sex-stratified comparisons within the following categories were conducted using chi-square analysis and ANOVA as appropriate: (1) enthesitis & fibromyalgia; (2) enthesitis only; (3) fibromyalgia only; (4) neither.Results:Baseline characteristics of the 4465 included patients are outlined in Table 1, stratified by sex. Enthesitis occurred in 44% (n=1984) of the population and was more common in females than males (48% vs 42%, pTable 1.Participant characteristics, stratified by sex. Values are mean (SD), median (25th, 75th) or n (%). P-values are independent T-tests or Mann-Whitney as appropriate.VariableTotalMaleFemaleP valueN446527241741Age, years45 (14)43 (14)46 (13)Disease duration, years11 (6, 20)12 (6, 21)11 (5, 19)0.01Delay to diagnosis, years3 (1, 9)3 (1, 9)3 (1, 10)0.11HLA-B27 positive2066 (66)1457 (73)609 (54)Radiographic sacroiliitis2517 (61)1788 (70)729 (46)Sacroiliitis on MRI1817 (65)1128 (68)689 (60)axSpA ASAS criteria2910 (65)1953 (72)957 (55)pSpA ASAS criteria555 (12)250 (9)305 (18)CASPAR criteria1043 (23)508 (19)535 (31)BMI, kg/m226 (23, 29)26 (23, 29)26 (23, 30)0.24Axial involvement3428 (76.8)2243 (82.3)1185 (68.1)Peripheral involvement2541 (56.9)1404 (51.5)1137 (65.3)Enthesitis1984 (44.4)1149 (42.2)835 (48.0)Uveitis738 (17)482 (18)256 (15)0.01Psoriasis1212 (27)615 (23)597 (34)Inflammatory bowel disease275 (6)150 (6)125 (7)0.02Enthesitis and FMS occurred together in 10% of the cohort, was more common in women than men (see Figure 1) and was associated with a significantly (p2 than people with enthesitis only. Objective confirmation of enthesitis was similar in those with and without FMS (38% vs 38%, p=0.92).The presence of FMS added to the burden of disease in those with enthesitis as assessed by BASDAI (6.4 vs 3.6, p0.05).Conclusion:In this large cross-sectional multinational analysis, FMS affected 19% of individuals with SpA. The co-existence of enthesitis and FMS occurred in 16% of females compared to 6% of males. The presence of FMS increased the burden of disease in those with enthesitis, as assessed by BASDAI and ASDAS-CRP, with no difference between men and women.Disclosure of Interests:Gillian Fitzgerald: None declared, Sinead Maguire Grant/research support from: Recipient of Gilead Inflammation Fellowship, Finbar Barry O’Shea: None declared, Clementina López-Medina: None declared, Maxime Dougados: None declared, Nigil Haroon Speakers bureau: Received honorarium from AbbVie, Eli Lilly, Jannsen, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, Jannsen, Novartis, UCB, Grant/research support from: AbbVie, Eli Lilly, Jannsen, Novartis, UCB.

Background:Knowledge about chronic inflammatory rheumatisc diseases and skills to administer and manage subcutaneous (subcut) biological DMARDs (bDMARDs) are key aspects to optimize patient’s self-management. Intervention of several successive health professionals (e.g comprehensive multidisciplinary team) has proven to be an effective method to improve patient’s self-management of their disease and treatment.Objectives:To assess the pharmacist’s impact on patient’s knowledge and skills during a multidisciplinary annual review. The secondary objectives were to assess this impact on therapeutic adherence and patient’s satisfaction as well as to determine the factors associated with the level of knowledge at baseline.Methods:Study type: prospective, monocentric, 6 months-follow-up, non-controlled study approved by Local Ethical Committee. Inclusion criteria: patient with either rheumatoid arthritis (RA) or spondyloarthritis (SpA), and treated with subcut bDMARDs. Intervention: The visit with a pharmacist evaluating and discussing patient’s knowledge and treatment adherence. At baseline (M0): date of the visit and, 3 (M3) and 6 months (M6) later, knowledge and adherence were assessed using self-administered questionnaires: Biosecure and CQR-5 respectively. A questionnaire was sent at M3 in order to evaluate the patient satisfaction. Endpoints: Primary: Changes in Biosecure score Secondary: Percentage of patients with high level of knowledge (score > 84) and percentage of patients with high adherence at M3 and M6; patient’s satisfaction; identification of patient’s factors (socio-demographics, rheumatisc disease treatments) associated with different levels of knowledge at baseline.Statistical analysis: repeated measures ANOVA, Bonferroni and Generalized Estimating Equation, univariate and multivariate linear regression.Results:The study was conducted from October 2019 to July 2020; 79 patients were included (age (years) = 50±15; sex ratio = 1.1; RA=25, SpA=54). The Biosecure scores changed from 71±18 to 82±15 (M3) and to 84±14 (M6) (pFactors associated with a better Biosecure score in the multivariate analysis were the following, lifestyle as a couple (pConclusion:Pharmacist’s intervention in the comprehensive multidisciplinary annual review resulted in a beneficial impact on patients’ knowledge and skills to manage their bDMARDs with a high level of satisfaction from a patient perspective.Disclosure of Interests:None declared

Background:Current recommendations for management of patients with axial Spondylarthritis (axSpA) include regular collection of validated disease activity outcomes.Objectives:This study aimed at evaluating the proportion of patients for whom the elements allowing the calculation of the validated outcome measures were available on the visits reported on the electronic medical records (EMR) and the factors associated with the presence of such information on the EMR.Methods:This was a cross-sectional and monocentric observational study conducted in a tertiary-care rheumatology department, EULAR center of excellence and ASAS center. We performed a systematic electronic search among all patients with a SpA diagnosis code who attended an outpatient visit between February 1st, 2018 and February 28th, 2019. Thereafter, a manual search was performed in order to check whether disease activity outcome measures (or the elements allowing its calculation): BASDAI individual questions, Disease activity Global, CRP, BASDAI and ASDAS) were reported on EMR. Patient’s and physician’s demographics disease characteristics (including treatment) and whether the patient had participated in a systematic review were also collected. A descriptive analysis of the percentage of EMR with available outcomes was performed, and the characteristics of patients in whom these measures were available/were not available evaluated by univariable and multivariable analysis (including only variables with p < 0,10 on the univariate)Results:320 EMR of axSpA patients seen in the outpatient clinic were screened and selected. Among them, 178 (55.6%) had at least one disease activity outcome measure reported, while 144(45%) and 123 (38.4%) had a BASDAI and an ASDAS reported, respectively. The most frequently reported disease activity items were duration of morning stiffness (n=230, 72%) and CRP (n=224, 70%).Only previous participation on an educational program for self-assessment was found to be independently associated with a reported disease activity outcome: among the patients participating in such program, 93.1% (n=27/29) had a disease activity measure available, compared to 51.9% (n=151/291) in those who did not participate in such program (pConclusion:Implementation of recommendations with regard to regularly collecting disease activity outcome measures is not optimal. The participation in educational programs including self-assessment educational programs might be one of the keys to improve such implementation.References:[1]Smolen JS, Braun J, Dougados M, Emery P, Fitzgerald O, Helliwell P, et al. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force. Ann Rheum Dis 2014;73:6–16. https://doi.org/10.1136/annrheumdis-2013-203419.[2]van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis 2017;76:978–91. https://doi.org/10.1136/annrheumdis-2016-210770.Figure 1.Frequency of disease activity measures reporting in the Electronic Medical Record of patients with axial Spondyloarthritis, followed in a tertiary care rheumatology department outpatient clinicTable 1.Factors associated with the presence of a reported disease activity measures on the electronic medical file of patients with axial SpADisclosure of Interests:Elodie Portier: None declared, Maxime Dougados: None declared, Christian Roux: None declared, Anna Moltó Consultant of: Abbvie, BMS, MSD, Pfizer, Lilly, UCB Novartis, Grant/research support from: Pfizer

Background:The efficacy and safety of the interleukin-17 inhibitor ixekizumab (IXE) for the treatment of radiographic (r-) and non-radiographic (nr-) axial spondyloarthritis (axSpA) has been shown for up to 52 weeks.1-2Objectives:To study the efficacy and safety of ixekizumab in the treatment of patients with r- and nr-axSpA for up to 116 weeks.Methods:COAST-Y (NCT03129100) is the 2-year extension of the COAST-V, -W, and -X trials. Patients continued with the dose received at the end of the originating trial at Week 52, either with 80 mg IXE every 4 weeks (Q4W) or every 2 weeks (Q2W). Patients who had been assigned to adalimumab or placebo were re-randomized to IXE Q4W or Q2W at Week 16 in COAST-V and -W. Patients who had received placebo for 52 weeks in COAST-X were switched to IXE Q4W in COAST-Y. Patients who switched from placebo or adalimumab treatment to IXE (COAST-V, -W, or -X) or from IXE Q4W to open-label IXE Q2W (COAST-X) during the originating studies were analyzed separately from patients continuously treated with IXE. Standardized efficacy measures were used (Table 1). Missing data were handled by non-responder imputation for categorical data and modified baseline observation carried forward for continuous data. Safety data were analyzed for all patients who received ≥1 dose of IXE.Table 1.Demographic and efficacy results for patients continuously treated with IXE for 116 weeksIXE Q4W N=157IXE Q2W N=195Demographics Age42.7 (13.0)41.8 (11.2) Male (n, [%])124 (79.0)132 (67.7) Baseline ASDAS3.92 (0.80)3.95 (0.76) Baseline BASDAI7.07 (1.26)7.18 (1.35) Baseline BASFI6.57 (1.76)6.74 (1.86) Baseline BASMI4.08 (1.46)3.97 (1.52) Baseline SF-36 PCS33.90 (7.27)33.26 (6.88)Outcome measureResponse (n, [%])Week 52Week 116Week 52Week 116 ASDAS 75 (47.8)69 (43.9)88 (45.1)96 (49.2) ASAS partial remission34 (21.7)31 (19.7)35 (17.9)39 (20.0) ASAS4082 (52.2)89 (56.7)99 (50.8)108 (55.4) BASDAI5078 (49.7)75 (47.8)83 (42.6)99 (50.8)Change from baseline ASDAS-1.64 (1.05)-1.60 (1.15)-1.63 (1.03)-1.78 (1.04) BASFI-2.88 (2.31)-2.76 (2.39)-2.83 (2.38)-3.15 (2.34) BASMI-0.57 (0.95)-0.57 (0.93)-0.53 (0.92)-0.60 (1.00) SF-36 PCS9.03 (8.62)8.43 (8.70)8.87 (7.57)9.86 (8.45)Data are mean (SD) unless otherwise noted. Non-responder imputation was used for categorical variables, and modified baseline observation carried forward for continuous variables.Results:Of the 773 patients enrolled in COAST-Y, 86.0% completed Week 116 of treatment (52 weeks of one of the originating trials and 64 weeks of COAST-Y). Among the patients continuously treated with IXE for 116 weeks (IXE Q4W: N=157; IXE Q2W: N=195), 46.9% achieved low disease activity (ASDAS Conclusion:Ixekizumab treatment led to consistent and sustained long-term improvements in disease activity and quality of life in patients with r- and nr-axSpA, with no new safety signals after up to 2 years of treatment.References:[1]Dougados, et al. Ann Rheum Dis 2020;79:176-185.[2]Deodhar, et al. Lancet 2020; 395:53-64.Disclosure of Interests:Juergen Braun Speakers bureau: Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Consultant of: Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Grant/research support from: Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Uta Kiltz Speakers bureau: AbbVie, Hexal, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Hexal, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Novartis, and Pfizer, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Giliad, GlaxoSmith & Kline, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmith & Kline, Novartis, Pfizer, and UCB, Tetsuya Tomita Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Takeda, Pfizer, Consultant of: AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Takeda, Pfizer, Maxime Dougados Consultant of: AbbVie, BMS, Eli Lilly and Company, Merck, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, BMS, Eli Lilly and Company, Merck, Novartis, Pfizer, Roche, and UCB, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Chen-Yen Lin Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jessica A. Walsh Consultant of: AbbVie, Amgen, Eli Lilly and Company, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Merck, and Pfizer

Background:Patients with a diagnosis of Spondyloarthritis (SpA) and Psoriatic Arthritis (PsA) may have predominant axial or peripheral symptoms, and the frequency and distribution of these symptoms may determine the clinical diagnosis by the rheumatologist (“clinical clusters”). Clustering analysis represents an unsupervised exploratory analysis which tries to identify homogeneous groups of cases (“statistical clusters”) without prior information about the membership for any of the cases.Objectives:To identify “statistical clusters” of peripheral involvement according to the specific location of these symptoms in the whole spectrum of SpA and PsA (without prior information about the diagnosis of the patients), and to evaluate whether these “statistical clusters” are in agreement with the “clinical clusters”.Methods:Cross-sectional and multicentre study with 24 participating countries. Consecutive patients considered by their treating rheumatologist as suffering from either PsA, axial SpA (axSpA) or peripheral SpA (pSpA) were enrolled. Four different cluster analyses were conducted: the first one using information about the specific location from all the peripheral musculoskeletal manifestations (i.e., peripheral arthritis, enthesitis and dactylitis), and thereafter a cluster analysis for each peripheral manifestation individually. Multiple correspondence analyses and k-means clustering methods were used. Distribution of peripheral manifestations and clinical characteristics were compared across the different clusters.Results:4465 patients were included in the analysis. Two clusters were found with regard to the location of all the peripheral manifestations (Fig. 1). Cluster 1 showed a low prevalence of peripheral manifestations in comparison with cluster 2; however, when peripheral involvement appeared in cluster 1, this was mostly represented by arthritis of hip, knee and ankle, as well as enthesitis of the heel. Patients from cluster 1 showed a higher prevalence of males (63% vs 44%), HLA-B27 positivity (69% vs 38%) and axial involvement (80% vs 52%), as well as more frequent diagnosis of axSpA (66% vs 21%) and more frequently fulfilling the ASAS axSpA criteria (69% vs. 41%). Patients from cluster 2 showed a higher prevalence of psoriasis (63% vs 25%), a more frequent diagnosis of PsA (61% vs 19%), and they fulfilled more frequently the peripheral ASAS (26% vs 11%) and the CASPAR criteria (57% vs 19%).Figure 1.Distribution of the peripheral involvement across clustersThree clusters were found with regard to the location of the peripheral arthritis. Clusters 2 and 3 showed a high prevalence of peripheral joint disease, although this was located more predominantly in the lower limbs in cluster 2, and in the upper limbs in cluster 3. Cluster 1 showed a higher prevalence of males, HLA-B27 positivity, axial involvement, a lower presence of psoriasis, a more frequent diagnosis of axSpA and fulfilling the ASAS axSpA criteria in comparison with clusters 2 and 3, respectively. Clusters 2 and 3 showed a higher prevalence of enthesitis and dactylitis in comparison with cluster 1, a more frequent diagnosis of PsA and fulfillment of the CASPAR criteria.Information about the location of enthesitis exhibited three groups: cluster 1 showed a very low prevalence of enthesitis, while cluster 2 and 3 showed a high prevalence of enthesitis, with a predominant involvement of axial enthesis in cluster 2 and peripheral enthesitis in cluster 3.Finally, the analysis of dactylitis also exhibited three clusters that showed a very low prevalence of dactylitis, predominantly toes and predominantly fingers involvement, respectively.Conclusion:These results suggest the presence of heterogeneous patterns of peripheral involvement in SpA and PsA patients without clearly defined groups, confirming the clear overlap of these peripheral manifestations across the different underlying diagnoses.Acknowledgements:This study was conducted under the umbrella of ASAS with unrestricted grant of Abbvie, Pfizer, Lilly, Novartis, UCB, Janssen and Merck.Disclosure of Interests:None declared

Background:Multimorbidity is frequent in rheumatoid arthritis (RA) and could interfere with the therapeutic response.Objectives:The aim of this study was to evaluate multimorbidity in the French cohort of early arthritis (ESPOIR cohort) and its possible impact on the therapeutic response.Methods:We included patients fulfilling 2010 ACR/EULAR criteria for RA. An adapted MultiMorbidity Index (aMMI) was developed [1]. Each patient was assigned scores of binary aMMI (0= no comorbidity, 1= at least 1 comorbidity) and counted and weighted aMMI. The primary endpoint was achievement of Clinical Disease Activity Index (CDAI) low disease activity after initiation of a first disease-modifying anti-rheumatic drug (DMARD) according to the aMMI. Secondary endpoints were other disease activity scores and response criteria. We collected data from the visit preceding the first DMARD initiation (baseline visit) and the visit after at least 3 months of treatment (follow-up visit). The impact of aMMI on therapeutic maintenance at 1, 3, 5 and 10 years was evaluated.Results:Analyses involved 472 patients: 302 (64%) had at least 1 comorbidity. Overall, 45.3% and 44.7% with binary aMMI= 0 or 1, respectively (p= 0.9), achieved CDAI low disease activity (Table 1). Similar results were found with counted and weighted aMMI. Use of other disease activity scores or response criteria did not show a significant impact of multimorbidity on the therapeutic response. Therapeutic maintenance was significantly better with binary aMMI = 1 than binary aMMI = 0. Increased counted aMMI was associated with increased probability of still being on the first initiated DMARD at each time point (Table 2).Table 1.Impact of aMMIs on CDAI, DAS28 and SDAI low disease activity (LDA) achievement at follow-up visit (univariate analyses)LDA achievementCDAIpDAS28pSDAIpYesNoYesNoYesNoBinary aMMI, n (%)077 (45.3)93 (54.7)0.9*85 (50.0)85 (50.0)0.2*80 (47.1)90 (52.9)0.9*1135 (44.7)167 (55.3)131 (43.4)171 (56.6)141 (46.7)161 (53.3)Counted aMMI, mean (SD)1.0 (1.1)1.1 (1.1)0.71.0 (1.1)1.1 (1.1)0.21.1 (1.1)1.1 (1.1)1.0Weighted aMMI, mean (SD)4.1 (5.2)4.0 (4.7)0.94.0 (5.2)4.1 (4.7)0.34.0 (5.0)4.0 (4.9)1.0aMMI= adapted MultiMorbidity Index; CDAI= Clinical Disease Activity Index; SDAI= Simplified Disease Activity Index* Proportion of patients achieving LDA between patients with binary aMMI= 0 and binary aMMI= 1. Because of no statistically significant results, no multivariate analysis was performed.Table 2.Probability of first DMARD maintenance at 1, 3, 5 and 10 years (multivariate analysis)Time pointFirst DMARD maintained or stoppedBinary aMMI#Counted aMMI§011 year(n= 530)Maintenance (n= 300)22981.71 (0.93)OR [95% CI]*> 999 [286.2->999]221.3 [84.0-583.0]Withdrawal (n= 230)205250.12 (0.37)3 years(n= 493)Maintenance (n= 285)102751.66 (0.94)OR [95% CI]*153.9 [73.0-324.5]26.1 [15.1-45.3]Withdrawal (n= 208)175330.22 (0.64)5 years(n= 459)Maintenance (n= 116)91071.72 (1.05)OR [95% CI]*10.9 [5.1-23.3]2.2 [1.8-2.7]Withdrawal (n= 343)1631800.82 (1.0)10 years(n= 415)Maintenance (n= 40)2381.58 (0.84)OR [95% CI]*14.0 [3.3-59.1]1.6 [1.2-2.0]Withdrawal (n= 375)1582170.99 (1.12)#data are number of patients§ data are mean (standard error)* data are odds ratios (ORs) and 95% confidence intervals (95% CI) of still being on the first initiated DMARD at 1, 3, 5 and 10 years between patients with binary aMMI = 1 and binary aMMI = 0 and according to counted aMMI, per additional point.Conclusion:In the ESPOIR cohort, therapeutic response to a first DMARD was not affected by multimorbidity but therapeutic maintenance was better in multimorbid patients.References:[1]Radner H, Yoshida K, Mjaavatten MD, et al. Development of a multimorbidity index: Impact on quality of life using a rheumatoid arthritis cohort. Semin Arthritis Rheum 2015;45:167–73.The variables included in multivariate analyses were sex, rheumatoid factor and/or anti-citrunillated peptide antibody positivity, age, CDAI at baseline visit, number of treatments at baseline visit.Acknowledgements:We are grateful to Nathalie Rincheval (Montpellier) for expert monitoring and data management and all the investigators who recruited and followed the patients (F. Berenbaum, Paris-Saint Antoine; MC. Boissier, Paris-Bobigny; A. Cantagrel, Toulouse; B. Combe, Montpellier; M. Dougados, Paris-Cochin; P. Fardellone and P. Boumier, Amiens; B. Fautrel, Paris-La Pitié; RM. Flipo, Lille; Ph. Goupille, Tours; F. Liote, Paris- Lariboisière; O. Vittecoq, Rouen; X. Mariette, Paris-Bicêtre; P. Dieude, Paris Bichat; A. Saraux, Brest; T. Schaeverbeke, Bordeaux; and J. Sibilia, Strasbourg).Disclosure of Interests:Aurélie BELTAI: None declared, Bernard Combe Speakers bureau: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Consultant of: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Grant/research support from: Novartis, Pfizer, and Roche, Amandine Coffy: None declared, Cécile Gaujoux-Viala: None declared, Cédric Lukas Speakers bureau: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai and UCB, Consultant of: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai and UCB, Grant/research support from: Pfizer, Novartis and Roche-Chugai, Alain Saraux Speakers bureau: AbbVie; Bristol-Myers Squibb; Lilly; Nordic; Novartis; Pfizer; Roche-Chugai; Sanofi and UCB, Consultant of: AbbVie; Bristol-Myers Squibb; Lilly; Nordic; Novartis; Pfizer; Roche-Chugai; Sanofi and UCB, Grant/research support from: AbbVie; Bristol-Myers Squibb; Lilly; Nordic; Novartis; Pfizer; Roche-Chugai; Sanofi and UCB, Maxime Dougados Speakers bureau: Pfizer, Abbvie, Lilly, UCB, Merck, BMS, Roche, Biogen, Sanofi, Novartis, Sandoz, Consultant of: Pfizer, Abbvie, Lilly, UCB, Merck, BMS, Roche, Biogen, Sanofi, Novartis, Sandoz, Grant/research support from: Pfizer, Abbvie, Lilly, UCB, Merck, BMS, Roche, Biogen, Sanofi, Novartis, Sandoz, Jean-Pierre DAURES: None declared, Charlotte Hua: None declared

Background:HLA-B27 is well known for its role in conferring susceptibility to spondyloarthritis (SpA), and several studies evaluating its association to axial SpA phenotype have been published. However, there is few evidence about its influence in patients affected with peripheral SpA (pSpA). In this sense we find ASAS perSpA registry suitable for this purpose.Objectives:To identify phenotypical differences in pSpA patients regarding HLA-B27 status.Methods:Data from all patients fulfilling ASAS pSpA criteria with HLA-B27-testing result available included in the ASAS perSpA study were used for this analysis. Socio-demographic and disease characteristics were collected. A descriptive and comparative analysis was performed between HLA-B27 positive and negative patients, using a simple logistic regression for all variables to assess their association to HLA-B27 positivity. Results were considered significant when p Results:Among the 4465 patients included in the registry, 555 fulfilled ASAS pSpA criteria and of them 286 had the HLA-B27 typing available. HLA-B27 was positive in 118 (41.3%) and negative in 168 (58.7%). Results are listed in Table 1. No differences were observed for gender distribution (males 55.1% in HLA-B27 positive vs 49.4% in HLA-B27 negatives). HLA-B27 positive patients were significantly younger, presented a younger disease onset, had significantly higher prior axial involvement, radiographic sacroiliitis and higher root joint involvement. On the other hand, HLA-B27 negative patients showed longer disease duration with a higher diagnosis delay. Around half of the patients in both groups showed a mono or oligoarticular pattern without differences regarding HLA-B27 status, however, psoriatic arthritis (PsA) and peripheral joint damage was significantly higher in HLA-B27 negative patients. Also psoriasis and inflammatory bowel disease (IBD) were more frequent in HLA-B27 negative patients compared to positive ones, and acute anterior uveitis (AAU) was significantly more frequent in HLA-B27 positive patients without differences in number of AAU episodes lifelong. Finally, obesity and concomitant fibromyalgia were both more common in HLA-B27 negatives. No significant differences were found for the rest of variables evaluated.Table 1.HLA-B27+ (N = 118)HLA-B27- (N = 168)N/mean%/SDN/mean%/SDpObesity (BMI >30)1411,9%4426,3%0,003Men6555,1%8349,4%0,344Family history4437,3%5231,0%0,265Axial involvement6252,5%4225,0%Radiographic sacroilitis3028,3%2516,8%0,029Psoriathic arthritis2319,5%11272,6%Reactive arthritis54,2%31,8%0,229IBD arthritis10,9%84,8%0,098Mono/oligoarticular pattern5954,6%7651,0%0,566Root joint involvement5244,1%5432,1%0,04Tarsitis2218,6%169,5%0,028Enthesitis6252,5%6941,1%0,056Dactylitis3126,3%5130,4%0,452Peripheral structural damage97,6%4124,4%Psoriasis2117,8%12574,4%AAU2117,8%74,2%IBD21,7%137,7%0,039Fibromyalgia1513,2%4326,7%0,008Age (y)42,714,852,213,4Age onset (y)33,913,738,314,50,013Dx delay (m)4,78,27,79,80,009Disease duration (y)9,0610,214,211,6BASDAI3,92,24,42,40,06CRP16,925,11227,30,148ASDAS-CRP2,71,22,71,10,876AAU number of episodes6,88,42,11,70,265In the multivariate analysis, age at disease onset (OR 0.96, CI95% 0.94-0.98), disease duration (OR 0.96, CI95% 0.92-0.99), PsA (OR 0.28, CI95% 0.09-0.85), presence of psoriasis (OR 0.22, CI95% 0.07-0.64), IBD related arthritis (OR 0.03, CI95% 0.01-0.19), AAU (OR 3.63, CI95% 1.22-11.9) and tarsitis (OR 2.61, CI95% 1.01-6.98) were the most important variables independently associated to HLA-B27 status.Conclusion:Presence of HLA-B27 in pSpA patients was associated to a higher axial and root joint involvement, an earlier disease onset and presence of AAU, but not to PsA, psoriasis and IBD that were higher in HLA-B27 negative patients.Disclosure of Interests:Marta Arévalo Speakers bureau: Abbvie, Nordic Pharma, Clementina López-Medina: None declared, Victoria Navarro-Compán: None declared, Mireia Moreno Speakers bureau: Abbvie, Novartis, UCB, Bristol and AMGEN, María LLop Vilaltella Speakers bureau: Novartis, Joan Calvet: None declared, Jordi Gratacos-Masmitja Speakers bureau: During the course of the year, I have received funding for courses and conferences or as an advisor and speaker from MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene, and Lilly., Maxime Dougados: None declared

Background:Clinical characteristics of nonradiographic axial spondyloarthritis (nr-ax-SpA) are highly variable across patients, and may potentially vary across patient populations, particularly due to differing distributions of human leukocyte antigens (HLA) and other genetic factors. The majority of nr-ax-SpA studies have been conducted in Europe, the United States, and small studies are reported from Asia [1].Objectives:To delineate clinical characteristics of patients with nr-ax-SpA in Asian countries in comparison to other areas of the world.Methods:Utilizing the ASAS-COMOSPA data, an international cross-sectional observational study of SpA patients, we analyzed information on demographics, disease characteristics, comorbidities, and risk factors. Patients were classified by region: Asia (China, Japan, Singapore, South Korea, and Taiwan), and non-Asian countries (Europe, Americas, and Africa); patient characteristics, including diagnosis and treatment, were compared.Results:Among 3984 SpA patients included in the study, 1094 were from centers in Asian countries, and 2890 from other regions. 112/780 (14.4%) of axial SpA patients in Asian countries were nr-ax-SpA, substantially less than in other countries (486/1997, 24.3%). Nr-ax-SpA patients in Asian countries compared to nr-ax-SpA in other countries were more likely male (75.9 vs 47.1%), have onset (22.8 vs 27.8 years) and diagnosis (27.2 vs 34.5 years) at younger age, and experience less diagnostic delay (1.88 vs 2.92 years) (Table 1). Nr-ax-SpA patients in Asian countries have higher prevalence of positive HLA-B27 (90.6% vs 61.9%) and fewer peripheral signs such as arthritis, enthesitis, or dactylitis (53.6% vs 66.3%) but have similar rate of extra-articular manifestations (psoriasis, IBD, or uveitis) and co-morbidities. Disease activity, functional impairment, and inflammation on MRI were less in nr-ax-SpA patients in Asian countries. NSAIDs response was higher and use of methotrexate and b-DMARDs were lower among nr-ax-SpA in Asian countries.Conclusion:Among axial SpA patients, substantially lower frequency of nr-ax-SpA was observed in Asian countries compared to other regions of the world. Nr-ax-SpA patients in Asian countries were predominantly male, and had younger disease onset with higher HLA-B27 positivity rate and less peripheral signs, and better response to NSAIDs. These results offer an opportunity to improve both early diagnosis and treatment of nr-ax-SpA patients in Asian countries.Table 1.Characteristics of nonradiographic axial SpA in Asia versus non-Asian regionsVariablesAsianon-Asian regionsp valueN112486Age at disease diagnosis, yrs27.2 [21.1, 39.6]34.5 [27.7, 41.7]Diagnostic delay, yrs1.88 [0.27, 5.56]2.92 [0.59, 9.58]0.011Male (%)85 (75.9)229 (47.1)Sacroiliitis on MRI among tested (%)49 (67.1)341 (82.2)0.005HLA B27 positivity among measured (%)96 (90.6)273 (61.9)Inflammatory Back Pain (%)107 (95.5)478 (98.4)0.076Arthritis, enthesitis, or dactylitis (%)60 (53.6)322 (66.3)0.016Psoriasis (%)12 (10.7)82 (16.9)0.142Uveitis (%)20 (17.9)81 (16.7)0.870Inflammatory bowel disease (%)5 (4.5)27 (5.6)0.817Elevated CRP (%)37 (33.0)213 (43.8)0.048Physician global assessment (0-10)2.0 [1.0, 5.0]2.0 [1.0, 4.0]0.741Patient global assessment (0-10)3.0 [1.0, 6.0]4.0 [2.0, 6.0]0.012ASDAS-CRP1.40 [0.95, 2.08]1.97 [1.21, 2.78]BASFI0.8 [0.05, 2.65]2.9 [0.8, 5.6]Good response to NSAIDs (%)80 (71.4)272 (56.0)0.004Methotrexate use (%)18 (16.1)134 (27.6)0.016Biological DMARDs use (%)27 (24.1)191 (39.3)0.004References:[1]López-Medina C, Ramiro S, van der Heijde D, et al. Characteristics and burden of disease in patients with radiographic and non-radiographic axial Spondyloarthritis: a comparison by systematic literature review and meta-analysis. RMD Open. 2019 Nov 21;5(2): e001108.Acknowledgements:This study was conducted under the umbrella of the International Society for Spondyloarthritis Assessment (ASAS) and COMOSPA study was supported by unrestricted grants from Pfizer, AbbVie and UCB.Disclosure of Interests:Keisuke Ono: None declared, Mitsumasa Kishimoto Speakers bureau: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma, Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma, Sho Fukui: None declared, Satoshi Kawaai: None declared, Gautam A. Deshpande: None declared, Kazuki Yoshida Consultant of: OM1, Inc., Grant/research support from: Corrona, LLC, Naomi Ichikawa: None declared, Yuko Kaneko Speakers bureau: AbbVie, Astellas, Ayumi, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Hisamitsu, Jansen, Kissei, Pfizer, Sanofi, Takeda, Tanabe-Mitsubishi, and UCB, Taku Kawasaki: None declared, Kazuo Matsui: None declared, Mitsuhiro Morita: None declared, Kurisu Tada: None declared, Naoho Takizawa: None declared, Naoto Tamura: None declared, Atsuo Taniguchi: None declared, Yoshinori Taniguchi: None declared, Shigeyoshi Tsuji: None declared, Shigeto Kobayashi: None declared, Masato Okada: None declared, Clementina López-Medina: None declared, Anna Moltó Consultant of: AbbVie, Pfizer, MSD, Novartis, Gilead, Lilly and UCB, Grant/research support from: AbbVie, Pfizer, MSD, Novartis, Gilead, Lilly and UCB, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma, Employee of: Imaging Rheumatology bv. (Director), Maxime Dougados: None declared, Yoshinori Komagata: None declared, Tetsuya Tomita: None declared, Shinya Kaname: None declared.

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma

Background:Work outcomes in spondyloarthritis (SpA) have mostly been studied in axSpA, less in peripheral SpA (pSpA) or PsA. The ASAS-COMOSPA study showed that lower education, female gender and lower healthcare expenditures (HCE) are associated with lower odds of employment in SpA. However, it is unknown whether country-level factors or SpA phenotype (axSpA/pSpA/PsA) modify the effect of individual-level socioeconomic factors.Objectives:To examine whether associations between socioeconomic factors and work outcomes differ across SpA phenotype and whether associations for individual-level socioeconomic factors are modified by country-level factors.Methods:Working age patients (18-65 years) from the ASAS-perSpA (peripheral involvement in SpA) study were included. Associations between individual- (age, gender, education, marital status) and country-level socioeconomic factors (Human Development Index (HDI), HCE) with work outcomes (employment status (binary), absenteeism, presenteeism (tertiles)) were assessed using mixed-effects logistic and ordinal logistic models. Models were adjusted for confounders. Separate models for ASDAS, BASFI and BASDAI were created in turn due to collinearity. Effect modification by SpA phenotype and country-level factors was tested using interaction terms.Results:A total of 3835 patients (mean age 42 years, 61% males) from 23 countries worldwide were included (66% axSpA, 10% pSpA, 23% PsA). Being employed was associated with gender (male vs female OR 2.5; 95%CI 1.9-3.2), education (university vs primary OR 3.7; 2.9-4.7) and being married (vs single OR 1.3; 1.04-1.6) (Table 1). University (vs primary) education was associated with lower odds of absenteeism (OR 0.7; 0.5-0.7) and presenteeism (OR 0.5; 0.3-0.7). Associations were not statistically different across SpA phenotypes. HCE was significantly associated with all work outcomes: employment (OR 2.5; 1.5-4.1), absenteeism (OR 0.6; 0.4-0.9) and presenteeism (OR 0.6; 0.3-0.9). HDI results were similar. Gender discrepancy in odds of employment was greater in countries with lower socioeconomic development; eg, males had 3.5 higher odds of employment than females in countries with low HCE, whereas the difference was 1.8 fold in high HCE countries.Table 1.Effect of individual socio-economic factors on work outcomes.Employment statusOR (95% CI)AbsenteeismOR (95% CI)PresenteeismOR (95% CI)N378022182127Age1.43 (1.36,1.51)1.00 (0.99,1.01)1.00 (0.99,1.01)Age20.996 (0.995, 0.996)NS - uniNS - uniMale (vs female)2.48 (1.92,3.21)1.22 (0.96,1.56)0.97 (0.78,1.20)EducationPrimaryrefrefrefSecondary1.86 (1.48,2.35)0.69 (0.49,0.99)0.69 (0.49,0.99)University3.68 (2.87,4.72)0.67 (0.47,0.96)0.49 (0.34,0.69)Marital statusSinglerefrefrefMarried1.27 (1.04,1.56)0.95 (0.73,1.22)0.98 (0.78,1.22)Divorced or Widowed1.39 (0.98,1.97)1.39 (0.88,2.18)1.16 (0.74,1.82)ASDAS0.78 (0.72,0.84)1.51 (1.33,1.72)2.31 (2.04,2.61)FatigueNS - multi1.14 (1.09,1.21)1.30 (1.24,1.36)Depression0.70 (0.59,0.82)1.45 (1.15,1.82)1.95 (1.59,2.39)FibromyalgiaNS - multi1.62 (1.11,2.35)1.58 (1.03,2.41)BMINS - multi0.99 (0.97,1.02)NS - multiDactylitis1.41 (1.12,1.76)NS - uniNS - uniUveitisNS - multi0.62 (0.46,0.84)NS - uniNSAIDsNS - multi1.53 (1.18,1.99)1.32 (1.07,1.64)bDMARDsNS - multiNS - uni1.23 (1.01,1.51)Models used ASDAS rather than BASDAI/BASFI, which are collinear. NS, not significant in the univariable or multivariable model.Conclusion:Individual- (lower education) and country-level socioeconomic factors (lower healthcare expenditure) were both associated with (lower) work participation, independently of SpA phenotype. The disadvantageous effect of female gender on employment is particularly strong in countries with lower socioeconomic development. This highlights the need for wider societal interventions, such as improving education and healthcare investment, to improve work outcomes.Disclosure of Interests:Sizheng Steven Zhao: None declared, Elena Nikiphorou Speakers bureau: Pfizer, Lilly, AbbVie, Annelies Boonen Consultant of: Yes, Grant/research support from: Yes, Clementina López-Medina: None declared, Maxime Dougados: None declared, Sofia Ramiro Speakers bureau: Lilly, MSD, Novartis, UCB, Consultant of: AbbVie, Lilly, MSD, Novartis, UCB, Sanofi, Grant/research support from: MSD.

BackgroundBaricitinib is an oral, reversible, selective Janus kinase 1 and 2 inhibitor.MethodsIn this phase III, double-blind 24-week study, 684 biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with rheumatoid arthritis and inadequate response or intolerance to ≥1 conventional synthetic DMARDs were randomly assigned 1:1:1 to placebo or baricitinib (2 or 4 mg) once daily, stratified by region and the presence of joint erosions. Endpoint measures included American College of Rheumatology 20% response (ACR20, primary endpoint), Disease Activity Score (DAS28) and Simplified Disease Activity Index (SDAI) score ≤3.3.ResultsMore patients achieved ACR20 response at week 12 with baricitinib 4 mg than with placebo (62% vs 39%, p≤0.001). Compared with placebo, statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness were observed. In a supportive analysis, radiographic progression of structural joint damage at week 24 was reduced with baricitinib versus placebo. Rates of adverse events during the treatment period and serious adverse events (SAEs), including serious infections, were similar among groups (SAEs: 5% for baricitinib 4 mg and placebo). One patient had an adverse event of tuberculosis (baricitinib 4 mg); one patient had an adverse event of non-melanoma skin cancer (baricitinib 4 mg). Two deaths and three major adverse cardiovascular events occurred (placebo). Baricitinib was associated with a decrease in neutrophils and increases in low-density and high-density lipoprotein.ConclusionsIn patients with rheumatoid arthritis and an inadequate response or intolerance to conventional synthetic DMARDs, baricitinib was associated with clinical improvement and inhibition of progression of radiographic joint damage.Trial registration numberNCT01721057; Results.

We thank Wei et al 1 for their correspondence on the recently published European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis (PsA).2 The authors of this correspondence raise some interesting points. The first point relates to the role of cyclosporine A (CsA) in the treatment of patients with psoriatic disease. The authors mention that this drug is often used in Asia, in particular in skin psoriasis. They suggest that CsA could be proposed for PsA. While CsA is recommended for the management of skin psoriasis, …

Background:Baricitinib (Bari) is an oral, selective and reversible Janus kinase 1 and 2 inhibitor approved for the treatment of adults with active RA. In addition to long-term safety which has been disclosed previously with data up to 7 years [1], an important clinical consideration is whether treatment efficacy can be maintained over the long term.Objectives:To evaluate the long-term efficacy of once-daily Bari 4 mg in patients with active rheumatoid arthritis (RA) who were either naïve to or who had inadequate response (IR) to methotrexate (MTX)Methods:Post hoc analyses of data from two phase 3 studies, RA-BEGIN (MTX-naïve) and RA-BEAM (MTX-IR) for 52 weeks, and one long-term extension (LTE) study (RA-BEYOND) for an additional 96 weeks were conducted (148 weeks in total). At week 52, MTX-naïve patients initially treated with MTX monotherapy, Bari 4 mg monotherapy, or Bari 4 mg +MTX in RA-BEGIN were switched to open-label Bari 4 mg monotherapy for treatment in the LTE. Similarly, at week 52, MTX-IR patients initially treated with Bari 4 mg [+ background MTX noted as (+MTX) for RA-BEAM] or adalimumab (ADA) (+MTX) in RA-BEAM were switched to open-label Bari 4 mg (+MTX) for treatment in the LTE. Patients who received placebo (+MTX) were switched to open-label Bari 4 mg (+MTX) at week 24. The analyses of efficacy (SDAI) and physical function (HAQ-DI) were conducted on all patients who were randomized into the RA-BEGIN and RA-BEAM studies and had received ≥1 dose of study drug after randomization (mITT population). The proportion of patients who reached low disease activity (LDA), as measured by SDAI ≤11, was evaluated along with change from baseline in HAQ-DI. The non-responder imputation (NRI) method was used for the categorical analysis.Results:By week 24 in RA-BEGIN (N=584), 62% of patients treated with Bari 4 mg monotherapy or Bari 4 mg +MTX achieved SDAI LDA in comparison to 40% of pts in the MTX monotherapy group; response rates seen at week 24 in the Bari treatment groups were maintained through week 148 (Fig 1A). Similarly, by week 24 in RA-BEAM (N=1,305), 52% of patients treated with Bari 4 mg (+MTX) and 50% of patients treated with ADA (+MTX) achieved a SDAI LDA in comparison to 26% of patients from the PBO (+MTX) group. The response rate seen at week 24 with Bari 4 mg and ADA were maintained through week 148, even after patients switched from ADA to Bari 4 mg at week 52 (Fig 1B). Similar improvement and maintenance patterns in physical function measured by HAQ-DI were demonstrated. The overall discontinuation rate across treatment groups from RA-BEGIN (19.5%) and RA-BEAM (14.2%) have been published. In the LTE, the discontinuation rate from Bari treatment was 13.7% for patients originating from RA-BEGIN (1.1% due to lack of efficacy, 6.4% due to safety) and 12.6% for patients originating from RA-BEAM (1.8% due to lack of efficacy, 5.9% due to safety).Figure 1.Proportion of patients achieving SDAI ≤11 in the NRI analysis†In RA-BEGIN, rescue to Bari 4 mg + MTX was offered at week 24.‡In RA-BEAM, rescue to Bari 4 mg (+ MTX) was offered at week 16. At week 24, all PBO + MTX patients were switched to Bari 4 mg + MTX.§Upon entering RA-BEYOND at week 52, MTX and ADA patients were switched to Bari 4 mg.Conclusion:Long-term treatment with Bari 4 mg demonstrated the maintenance of clinically-relevant outcomes for up to 3 years. Low discontinuation rates during the LTE indicated that Bari 4 mg treatment was well-tolerated.References:[1]Genovese et al.Annals of the Rheumatic Diseases. 2019;78:308-309.Disclosure of Interests: :Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Li Xie Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Bochao Jia Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Peter C. Taylor Grant/research support from: Celgene, Eli Lilly and Company, Galapagos, and Gilead, Consultant of: AbbVie, Biogen, Eli Lilly and Company, Fresenius, Galapagos, Gilead, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer Roche, and UCB, Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Ayesha Elias Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Anabela Cardoso Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Robert Ortmann Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Chad Walls Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

Background:Current recommendations for axial spondyloarthritis (axSpA) management include tight control and treat-to-target (TC) strategies, but no study has evaluated its potential benefitObjectives:To evaluate the benefit of TC strategies in comparison to usual care (UC) in patients with axSpA.Methods:Study design:Pragmatic, prospective, cluster-randomized controlled (2 arms), one-year trial (NCT03043846).Centers: 18 axSpA expert centers randomly allocated (1:1) to the treatment arm: TC vs. UC.Patients: axSpA diagnosis and ASAS criteria, non-optimally treated with NSAIDs, bDMARD-naïve, and ASDAS > 2.1 at inclusion.Study treatment:a) TC arm: the strategy was pre-specified by the scientific committee based on current axSpA recommendations and aiming at a target (ASDAS b) UC arm:treatment decisions were at the rheumatologist’s discretion with visits every 12w.Outcomes:the % of patients with a significant (>30%) improvement in the ASAS-HI score over one-year follow-up was the main outcome. Other outcomes (disease activity, quality of life, treatment, …) over follow-up were evaluated (Table 1). The number/type of adverse events were collected.Statistical analysis: this was an intention-to-treat analysis. To take into account the cluster-randomization design, for all outcomes, two models were performed: first a two-level mixed model with 2 random effects was used to estimate the % of responders/the change of the outcome over follow-up (i.e. mod1); in a second step, the imbalanced variables observed at baseline were included in the model (i.e.mod2). Cost-effectiveness was assessed by estimating the (baseline- and cluster-adjusted) incremental cost per quality-adjusted life-year (QALY) gained for TC vs. UC.Estimated outcomes at week 48Cluster-adjusted (mod1)Cluster and imbalance-adjusted (mod2)TCUCASDAS LDA*76.5%59.5%0.03ASDAS ID25.9%18.7%--ASDAS CII61.2%46.0%0.02ASDAS MI16.5%14.9%--ASAS4052.3%34.7%0.01ASAS2094.9%85.9%0.03BASDAI 5079.0%43.8%0.010.03Physician Global (0-10)2.0 (0.2)1.8 (0.2)--CRP (mg/L)3.9(1.4)3.5 (1.5)--BASG (0-10)2.6 (0.5)3.4 (0.5)0.09-BASFI (0-10)1.7(0.5)2.4 (0.5)--ASAS HI SMD47.3%36.1%--EQ5D0.7(0.1)0.8(0.1)0.02-ASAS-NSAID score1.5(2.2)- 4.9 (2.9)--Results:160 patients were included (80 in TC and 80 in UC). Mean age was 37.9(11.0) years with a disease duration of 3.7(6.2) years, 51.2% were males. A radiographic damage of the SI-joints, a (ever) positive MRI sacroiliitis and HLA-B27+ were seen in 46.9%, 81.9% and 75.0% patients respectively. Mean ASDAS at inclusion was 3.0 (0.7) and mean ASASHI was 8.6 (3.7). 72 patients per group attended the one-year visit. Although 47.3% vs. 36.1% patients in the TC and UC arms achieved a significant improvement in ASASHI at the one-year visit, the difference was not statistically significant, with either model. Across all other outcomes a trend was observed in favor of the TC arm (Table 1). The number of bDMARDs was significantly higher in TC arm (56.2% vs. 27.2%). The number of infections was comparable in both groups (15 vs. 16 in the TC and UC, respectively), with only 2 severe infections occurring in the UC arm. From a societal perspective, TC resulted in an additional 0.04 QALY and saved €265 when compared to UC and a 67% probability of being cost-effective at a cost-effectiveness threshold of €20,000 per QALY.Conclusion:In this setting of SpA expert centers, UC resulted in a good outcome in a substantial number of patients but the TC was not superior for the primary outcome despite a greater number of bDMARDs prescription. Nevertheless, a general trend in favor of the tight control was observed, with a comparable safety profile and was found to be favorable from a societal health economic perspective.Acknowledgments:this trial has been conducted thanks to an unrestricted grant from UCBDisclosure of Interests:Anna Moltó Grant/research support from: Pfizer, UCB, Consultant of: Abbvie, BMS, MSD, Novartis, Pfizer, UCB, Clementina López-Medina: None declared, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Casper Webers: None declared, Emmanuelle Dernis Speakers bureau: Lilly, Novartis, Floris A. van Gaalen: None declared, Martin SOUBRIER: None declared, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review, Mirian Starmans-Kool: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

Background:In chronic rheumatic diseases, non-adherence to treatment is associated with a progression of disease and an increased morbidity (1). In spondyloarthritis (SpA), improving patients’ knowledge on their subcutaneous biologic disease-modifying antirheumatic drugs (bDMARDs) is a key factor to enhance medication adherence (2). The patient information has to ensure the acquisition of safety skills regarding their treatment management.Objectives:To evaluate the impact of a pharmacist’s educational interview on knowledge and therapeutic adherence of subcutaneous bDMARDs in patients with SpA.Methods:Population and study design:consecutive adult patients with well-controlled axial SpA, stable on subcutaneous bDMARDs were enrolled in a randomized, controlled, single-center, open-label, 6-months trial.Intervention:A pharmacist’s educational interview provided information on bDMARDs management at baseline in the intervention group (IG) and at month 6 (M6) in the control group (CG). A booklet containing essential information was given to the patient.Intervention allocation:After written consent, the study treatment was randomly allocated via a computer program by simple randomization, with an allocation ratio of 1:1.Outcome measures:The change of a weighted knowledge score (0 – 100) concerning the bDMARDs management and the change in the Medication Possession Ratio (MPR) at M6 were primary outcomes. The changes in disease activity (BASDAI) and patients’ satisfaction regarding the pharmacists’ interview were secondary outcomes.Statistics:Changes in knowledge score, MPR and BASDAI were compared between the two groups using the T-Student test. Statistical analysis was performed in intention-to-treat. Missing data was handled with multiple imputations.Results:Patients’ characteristics at baseline were comparable among the 89 included patients (46 in IG, 43 in CG). The means ± SD of the knowledge score were 75.3 ±14.2 versus 73.0 ±13.2 and 86.3 ±12.6 versus 76.0 ±14.1 in the IG versus CG at baseline and at M6, respectively. The patient’s knowledge score improved at a greater magnitude in the IG (+11.0 ±11.5 versus +3.0 ±10.6 in the IG versus the CG respectively, pConclusion:Pharmacists’ educational interview on subcutaneous bDMARDs is effective in improving the knowledge of patients with SpA on their treatment. Regarding therapeutic adherence, a trend in favor of an improvement was observed in the intervention group but did not reach the statistically significance. Nevertheless, the results observed in this study are an argument to propose to include the pharmacists in the multidisciplinary team in charge of the management of patients with SpA.References:[1] Bluett J, Morgan C, Thurston L et al. Impact of inadequate adherence on response to subcutaneously administered anti-tumour necrosis factor drugs: results from the biologics in rheumatoid. Rheumatology. 2015;54(3):494-9.[2] Gossec L, Molto A, Romand X et al. Recommendations for the assessment and optimization of adherence to disease-modifying drugs in chronic inflammatory rheumatic diseases: A process based on literature reviews and expert consensus. Joint Bone Spine. 2019;86(1):13-9.Disclosure of Interests:Loriane Gutermann: None declared, Sophie Dumas: None declared, Clementina López-Medina: None declared, Léa Boissinot: None declared, Camille Cotteret: None declared, Valérie Perut: None declared, Anna Moltó Grant/research support from: Pfizer, UCB, Consultant of: Abbvie, BMS, MSD, Novartis, Pfizer, UCB, Ornella Conort: None declared, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

Background:Standardization of clinical practice has been proven to be effective in management of chronic diseases. This is particularly true at the time where the concept of treat to target is becoming more and more important in the field of axial spondyloarthritis (ax-SpA).Objectives:To propose a list of variables to be collected at the time of the diagnosis and over the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice.Methods:The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of axSpA via a systematic literature research, (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of the variable in a 4 grade scale from ”potentially useful” to “mandatory”, (3) a consensus on optimal timeline for periodic assessment of the selected variables on a 5 grade scale from “at each visit” to “never to be re-collected”.Results:The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Concerning the data to be collected at the time of the diagnosis and during follow-up, we proposed to differentiate the results based on a) the way of collection of the variables (e.g. questionnaires by the patient, interview by the physician, physical examination, investigations) b) the usefulness these variables in daily practice based on the opinion of the rheumatologists ” c) the optimal timeline between 2 evaluations of the variable based on the opinion of the rheumatologists. In the initial systematic review, symptoms of heart failure history of inflammatory bowel disease, psoriasis or uveitis, patient global visual analogic scale, spine radiographs, modified Schöber test, coxo-femoral rotations, swollen joint count, urine strip test, BASDAI and ASDAS global scores were considered very useful and nocturnal back pain/morning stiffness, sacro-iliac joints radiographs and CRP were considered mandatory (Figure 1). Timeline between 2 evaluations of variables to collect in the periodic review are summarized inFigure 2.Figure 1.Core sets of items to collect and report in the systematic review in axial spondyloarthritis management in daily practice ASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, BASFI=Bath Ankylosing Spondylitis Functionnal Index, BASMI=Bath Ankylosing Spondylitis Metrology Index, CRP=C Reactive Protein, CT=computerized tomography, FIRST=Fibromyalgia Rapid Screening Tool, HLA=Human Leukocyte Antigen, MRI=Magnetic resonance imaging, PET=positron emission tomography.Figure 2.Periodic review timeline of variables to collectASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, Spondylitis Metrology Index, CRP=C Reactive Protein, IBD = inflammatory bowel diseases, PRO = Patient Reported OutcomesConclusion:Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported at the time of the diagnosis and during follow-up of patients with ax-SpA in daily practice.Acknowledgments:this study has been conducted in two parts: the first one (evidence-based) was conducted thanks to a support from Abbvie France. AbbVie did not review the content or have influence on this manuscript. The second part of this initiative (consensus) has been conducted thanks to a support from the scientific non-profit organization: Association de Recherche Clinique en RhumatologieDisclosure of Interests:Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review, Xavier Romand Consultant of: Xavier ROMAND has received honorarium fees from Abbvie, Arnaud Pfimlin Consultant of: Arnaud PFIMLIN has received honorarium fees from Abbvie, Mickael Dalecky Consultant of: Mickael DALECKY has received honorarium fees from Abbvie, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

Background:Axial Spondyloarthritis (ax-SpA) displays an increased cardiovascular disease (CVD) risk compared with the general population. Although ischemic cardiac manifestations are well known, prevalence of non-ischemic manifestations such as myocardial dysfunction and valvulopathy is less clear.Objectives:To compare prevalence of myocardial dysfunction and valvulopathy by ultrasound in ax-SpA patients and versus healthy controls.Methods:Two investigators independently searched for studies indexed in PUBMED, Cochrane Library and EMBASE databases and published before January 17th 2020. The search was focused on ultrasound evaluation of myocardial function and valvulopathy, with two-dimensional, Doppler, tissue Doppler, and speckle tracking echocardiography. We included for meta-analysis all controlled studies including ax-SpA without previous cardiovascular disease. Data were pooled using appropriate random or fixed effects model.Results:Literature search retrieved of 186 abstracts. A total of 31 papers were included in the systematic review and 27 papers were analyzed in the meta-analysis (1,494 ax-SpA patients and 1,091 healthy controls). Studies displayed cross-sectional design and included ax-SpA without prevalent cardiovascular disease.Ax-SpA was defined according to the modified New York criteria (24 studies) followed or the ASAS criteria (2 studies). HLA B27+ positivity ranged from 51 to 100%, mean age ranged from 26.7 to 55.7 years, disease duration ranged from 3.2 to 23.3 years and mean BASDAI ranged from 1.24 to 5.6.Patients with ax-SpA displayed a lower diastolic function with a lower E/A ratio, a higher deceleration time, a higher isovolumetric relaxation time and a lower systolic function with a lower ejection fraction (figure 1). Left-ventricular end diastolic and systolic diameters were higher in ax-SpA patients with respectively mean difference 0.55 mm [CI95%; 0.19, 0.91] and 0.79 mm [CI95%; 0.40, 1.17]. We did not find any difference for left and posterior ventricular thickness, left atrial dimension, and left ventricular mass index.Figure 1.Systolic and diastolic dysfunction is slightly altered in ax-SpA patients compared to healthy individuals Diastolic dysfunction was assessed by (A) E/A ratio (m/s), (B) deceleration time (ms), (C) Isovolumetric relaxation time (ms) and (D) systolic function was assessed by ejection fraction (%).A total of 15 articles reported prevalence of valvulopathy in ax-SpA. Prevalence of mitral regurgitation and aortic regurgitation were similar in ax-SpA patients and healthy individuals: OR=1.13 [CI95% 0.76, 1.68] and OR=1.18 [CI95% 0.68, 2.04].Conclusion:Prevalence of valvulopathy was similar in ax-SpA and healthy individuals. Diastolic and systolic function seems to be slightly altered in ax-SpA compared to healthy controls. However, this difference is unlikely clinically relevant. Usefulness of systematic echography remains to be determined in future longitudinal studies.Disclosure of Interests:Fanny Adeline: None declared, Xavier Romand Consultant of: Xavier ROMAND has received honorarium fees from Abbvie, Mickael Dalecky Consultant of: Mickael DALECKY has received honorarium fees from Abbvie, Arnaud Pfimlin Consultant of: Arnaud PFIMLIN has received honorarium fees from Abbvie, Daniel Wendling: None declared, Philippe Gaudin Speakers bureau: Lilly, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review

Background:EULAR- recommendations for management of early arthritis formulated that patients should be referred to, and seen by a rheumatologist, within 6-weeks after symptom onset. The mentioned period of ≤6-weeks after symptom onset is shorter than ≤12-weeks, the period that is generally considered as the ‘window-of-opportunity’. Because implementation provides challenges, and evidence supporting that referral ≤6-weeks is better than e.g. Objectives:We used an observational study design to investigate in two cohorts if time-to-encounter (TtE) a rheumatologist ≤6-weeks, compared to 7-12-weeks, results in better disease long-term outcomes, measured with sustained DMARD-free remission (SDFR) and radiographic progression.Methods:Consecutive 1987-RA patients of the Leiden EAC (n=1025) and ESPOIR (n=514) were studied during median 7 and 10 years follow-up. Patients were categorized on duration between symptom onset and first encounter with a rheumatologist; ≤6-, 7-12-, and >12-weeks. Multivariable Cox regression (SDFR), linear mixed models (radiographic progression), and meta-analyses were used.Results:Leiden RA-patients encountered the rheumatologist within 6-weeks obtained SDFR more often than patients seen within 7-12-weeks (HR 1·59, 95%CI:1·02-2·49), and >12-weeks (HR 1·54, 95%CI:1·04-2·29). In ESPOIR, similar but non-significant effects were observed; meta-analysis showed that within 6-weeks was better than 7-12-weeks (HR 1·69, 95%CI:1·10-2·57, Figure 1-A) and >12-weeks (HR 1·67, 95%CI:1·08-2·58). Patients encountered the rheumatologist within 6-weeks had similar radiographic progression than those seen 7-12-weeks, in any cohort, or meta-analysis (Figure 1-B).Figure 1Meta-analyses of time-to-encounter the rheumatologist and the chance of achieving sustained DMARD-free remission (A) and radiographic progression (B)Conclusion:Scientific evidence underlying the first EULAR recommendation depends on the outcome of interest; visiting a rheumatologist within 6-weeks of symptom-onset had clear benefits for achieving SDFR, but not for radiographic progression.References:None.Disclosure of Interests:Ellis Niemantsverdriet: None declared, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Annette van der Helm - van Mil: None declared

Background:We previously failed to find any significant difference with regard to severe outcomes (death, severe infections, fractures, cardiovascular diseases [CVD]) between recent-onset RA patients taking or not low-dose GC treatment in a 7-year analysis of the ESPOIR cohort (1).Objectives:To explore the 10-year tolerability profile of GC use in patients with early RA.Methods:We analysed data from the early arthritis (less than 6 months disease duration) ESPOIR cohort. Patients were stratified in two groups, with or without GC treatment at least once during their follow-up (median 10 years IQR [9-10]). The primary outcome was a composite of death, CVD (including myocardial ischemia, cerebrovascular accident and heart failure), severe infection and fracture. In order to reduce the impact of treatment selection bias and potential confounding factors, the weighted Cox time-dependent analysis model was used with inverse probability of treatment weighting (IPTW) propensity score method.Results:Among the 608 RA patients (480 women, mean age of 47.5 ± 12.1 years), 397 patients (65%) received low-dose prednisone (median 1.9 mg/day [IQR 0.6-4.2], mainly during the first 6 months (70%). The mean duration of GC treatment was 44.6 months ± 40.1. Overall, 95 events were identified during follow-up: 10 deaths, 18 CVD, 32 fractures and 35 severe infections. Based on univariate analysis at 10 years, patients taking GC experienced significantly more events (n=71) than those without GC (n=24) (p=0.035), especially severe infections (n=30 with GC versus 5 without GC, p=0.009) (table 1), with a cumulative dose effect (p=0.007).On weighted Cox time-dependent analysis, using the IPTW propensity score method, the risk of events over time was significantly associated with GC treatment (p ) (figure 1 and table 2).Table 1.Primary outcome and events at 10 years: univariate analysisTotal study population (n=608)Without GCWith CGP ValuePrimary outcome95 (15.6%)24 (11.4%)71 (17.9%)0.035Death10 (1.6%)1 (0.5%)9 (2.3%)0.103Cardiovascular diseases18 (3%)3 (1.4%)15 (3.8%)0.177Severe infections35 (5.8%)5 (2.4%)30 (7.6%)0.009Fractures32 (5.3%)15 (7.1%)17 (4.3%)0.137Table 2.Time-dependent relationship between glucocorticoids treatment and risk of eventsestimated by hazard ratioTime (Months)Hazard Ratio (95% CI)120.46 (0.23 - 0.90)240.62 (0.36 - 1.08)360.83 (0.52 - 1.33)481.12 (0.73 - 1.72)601.52 (0.96 - 2.40)722.05 (1.19 - 3.52)842.77 (1.44 - 5.34)963.74 (1.69 - 8.26)1085.05 (1.98 - 12.91)1206.83 (2.29 - 20.35)Figure 1.Time-dependent relationship between glucocorticoids treatment and risk of eventsestimated by hazard ratio (HR)Conclusion:This 10-year analysis of the ESPOIR cohort supports a dose and time-dependent impact of very low-dose GC treatment in early RA, with a long-term high risk of severe outcomes.Disclosure of Interests:Camille Roubille Consultant of: Servier, Pfizer, Novartis, Amandine Coffy: None declared, Nathalie Rincheval: None declared, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Rene-Marc Flipo Speakers bureau: Novartis, Janssen, Lilly, Jean-Pierre Daures: None declared, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB

Background:Axial spondyloarthritis (axSpA) is a chronic rheumatic disease that encompasses various clinical presentations: inflammatory chronic back pain, peripheral manifestations and extra-articular manifestations. The current nomenclature divides axSpA in radiographic (in the presence of radiographic sacroiliitis) and non-radiographic (in the absence of radiographic sacroiliitis, with or without MRI sacroiliitis. Given that the functional burden of the disease appears to be greater in patients with radiographic forms, it seems crucial to be able to predict which patients will be more likely to develop structural damage over time. Predictive factors for radiographic progression in axSpA have been identified through use of traditional statistical models like logistic regression. However, these models present some limitations. In order to overcome these limitations and to improve the predictive performance, machine learning (ML) methods have been developed.Objectives:To compare ML models to traditional models to predict radiographic progression in patients with early axSpA.Methods:Study design: prospective French multicentric cohort study (DESIR cohort) with 5years of follow-up. Patients: all patients included in the cohort, i.e. 708 patients with inflammatory back pain for >3 months but Results:10-fold cv-AUC for traditional models were 0.79 and 0.78 for M2 and M3, respectively. The 3 best models in the ML algorithm were the GAM, the DBARTS and the Super Learner models, with 10-fold cv-AUC of: 0.77, 0.76 and 0.74, respectively (Table 1).Table 1.Comparison of 10-fold cross-validated AUC between best traditional and machine learning models.Best modelsCross-validated AUCTraditional models M2 (step AIC method)0.79 M3 (LASSO method)0.78Machine learning approach SL Discrete Bayesian Additive Regression Trees Samplers (DBARTS)0.76 SL Generalized Additive Models (GAM)0.77 Super Learner0.74AUC: Area Under the Curve; AIC: Akaike Information Criterion; LASSO: Least Absolute Shrinkage and Selection Operator; SL: SuperLearner. N = 295.Conclusion:Traditional models predicted better radiographic progression than ML models in this early axSpA population. Further ML algorithms image-based or with other artificial intelligence methods (e.g. deep learning) might perform better than traditional models in this setting.Acknowledgments:Thanks to the French National Society of Rheumatology and the DESIR cohort.Disclosure of Interests:Romain Garofoli: None declared, Matthieu resche-rigon: None declared, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Christian Roux: None declared, Anna Moltó Grant/research support from: Pfizer, UCB, Consultant of: Abbvie, BMS, MSD, Novartis, Pfizer, UCB

Background:Long-term observational studies on the prediction of structural damage progression (SDP) in rheumatoid arthritis (RA) have mostly considered patients baseline characteristics and have rarely evaluated the specific impact of treatments in real world settings.Objectives:To assess the impact of treatments exposure on the 10-year radiographic progression in early rheumatoid arthritis (RA).Methods:The 310 patients of the ESPOIR cohort fulfilling ACR/EULAR 2010 criteria at baseline and having complete radiographic data at baseline and 10 years were considered in the present study. SDP was defined at 10 years as a significant increase of the Sharp/van der Heijde score, i.e., superior to the Smallest Detectable Change of 11.5 at 10 years. Three RA treatments were considered: glucocorticoids (GC), conventional synthetic and biologic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs and bDMARDs), which posologies were standardized by the mean of dose quotients (DoseQ). Drug exposure was modelled with Weighted Cumulative Exposure (WCE) variables, considering the intensity of drug exposure defined as a weighted function of past doses, and was incorporated into a logistic regression model that also included baseline clinical, biological and radiological characteristics. The predictive performance of this WCE model was compared to models considering on the one hand only baseline characteristics (BSL model) and on the other, baseline characteristics and binary treatments exposure - in other terms, “ever exposed, yes or no” (BIT model).Results:Overall, SDP at 10 years occurred in 85 (27.4%) patients. GC exposure was significantly associated with SDP in univariate analysis only, and therefore was not included in the final WCE model. In the final WCE model, the joint exposure to 1 DoseQ of csDMARD and 1 DoseQ of bDMARD during the 10-year follow-up was associated with a significant protective effect on SDP compared to patients receiving no treatment: OR=0.04 (95% CI: 0.002-0.72). Early csDMARD initiation was associated with a significantly lower risk of SDP compared to later initiation (Table 1).Table 1.odd ratios for the association of patterns of drug regimen with 10-year radiographic progressionExposure testedReferenceOR (95%CI)Treatments intakes during the last 10 yearscsDMARD & bDMARD for last 10 yearsNo treatment for last 10 years0.04 (0.002-0.72)Testing the interest of an early initiation of csDMARDs (not combined with bDMARD)csDMARD for last 10 yearscsDMARD after month 30.79 (0.65-0.96)csDMARD after month 60.41 (0.19-0.86)csDMARD after year 10.13 (0.02-0.80)Testing the interest of an early initiation of bDMARDs (in association with csDMARD)bDMARD after month 3No treatment for last 10 years0.04 (0.002-0.72)bDMARD after month 60.04 (0.002-0.72)bDMARD after year 10.04 (0.002-0.72)bDMARD after year 20.04 (0.003-0.73)bDMARD after year 30.05 (0.03-0.81)Initiation of a bDMARD between the 3rd month and 3rd year of follow-up in combination with a csDMARD was significantly associated with a lower risk of SDP compared to no bDMARD treatment (Table 1).The final WCE model was better at predicting SDP at 10 years compared to the BSL and BIT models, with AUC=0.92 (95% CI: 0.89-0.95) (Figure 1).Figure 1.ROC curves of BSL model (A), BIT model (B) and WCE combined model (C) for 10-year radiographic progressionConclusion:CsDMARDs and bDMARDs have a protective effect on radiographic progression at 10 years in RA patients. This study has shown the value of considering drug exposure in the study of RA prognosis, and modeling this exposure using WCE variables.Disclosure of Interests:Joanna KEDRA: None declared, David Hajage: None declared, Alexandre Lafourcade: None declared, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB

Background:Previous studies have shown that withdrawing tumour necrosis factor inhibitors (TNFi) in patients (pts) with axial spondyloarthritis (axSpA) who have achieved sustained remission often leads to relapse.1However, none have formally tested TNFi dose reduction strategies in a broad axSpA population or evaluated whether relapse following TNFi dose reduction and withdrawal is associated with a specific demographic subgroup.Objectives:C-OPTIMISE evaluated the percentage of pts without flare after TNFi dose continuation, reduction or withdrawal in adults with early axSpA treated with the Fc-free, PEGylated TNFi certolizumab pegol (CZP). Here, we analyse whether responses to reduced maintenance dose were comparable in pts stratified by axSpA subpopulation, gender and age.Methods:C-OPTIMISE (NCT02505542) was a multicentre, two-part phase 3b study in adults with early (3.5 at any timepoint) during Wks 48–96. Analyses were conducted on subgroups according to axSpA subpopulation, gender and age ≤/> the median age of the randomised set (32 years).Results:During the 48-wk induction period, 43.9% of patients (323/736) achieved sustained remission and 313 pts entered the 48-wk maintenance period (r/nr-axSpA: 168/145 pts; males/females: 247/66 pts; age ≤32/>32: 165/148 pts). During the maintenance period, responses in r- and nr-axSpA pts were comparable across all three randomised arms. 83.9% r-axSpA and 83.3% nr-axSpA pts receiving the full CZP maintenance dose did not experience a flare, and in the reduced maintenance dose arm 82.1% r-axSpA and 75.5% nr-axSpA pts did not experience a flare. In the PBO group this was reduced to 17.9% and 22.9%, respectively. Similar responses were seen in pts stratified by gender or age, with substantially higher percentages of pts randomised to CZP full or reduced maintenance dose remaining free of flares compared to PBO in all subgroups (Figure).Conclusion:The results of C-OPTIMISE indicate that a reduced maintenance dose is suitable for pts with axSpA who achieve sustained remission following 1 year of CZP treatment, regardless of axSpA subpopulation, gender or age. Complete treatment withdrawal is not recommended due to the high risk of flare.References:[1]Landewe R. Lancet 2018;392:134–44.Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello MedicalDisclosure of Interests:Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Karl Gaffney Grant/research support from: AbbVie, Celgene, MSD, Novartis, Pfizer, and UCB Pharma, Consultant of: AbbVie, Celgene, MSD, Novartis, Pfizer, and UCB Pharma, Speakers bureau: AbbVie, Celgene, MSD, Novartis, Pfizer, and UCB Pharma, Lars Bauer Employee of: UCB Pharma, Bengt Hoepken Employee of: UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Karen Thomas Employee of: UCB Pharma, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB