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ObjectivesEarly initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA.MethodsThis investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (ResultsThe primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms.ConclusionsIn patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission.Trial registration numberNCT01871649.

Background:Although the prevalence of Psoriatic Arthritis (PsA) is the same in men and women, women experience a higher burden of disease (pain, disability, fatigue) (1).The persistent belief that women tend to over-report their symptoms compared to men may also contribute to under or delayed diagnosis in women. The clinical pattern of PsA also differs, with men presenting more commonly with peripheral and axial joint damage and women being affected more frequently by polyarthritis (2). Furthermore, most disease activity measures contain pain and quality of life measurement metrics that may perform differently by sex. As a result, this may affect the clinician’s perception of disease severity, influence management decisions and subsequently introduce sex bias in prescribing.Objectives:To assess sex-related differences in baseline demographics, disease characteristics and evolution over 1 year in patients with newly diagnosed PsA.Methods:Our study is embedded in the Dutch south-west Early Psoriatic Arthritis prospective cohort study. We described patient characteristics using simple descriptive analysis techniques. For the comparison across sexes and baseline and 1 year follow up, appropriate tests depending on the distribution were used.Results:273 men and 294 women with no significant differences in age and ethnicity were included. Women reported significantly longer duration of symptoms before diagnosis and significantly fewer of them were in paid employment at baseline. Oligoarthritis was the most common pattern of arthritis in both sexes. Polyarthritis and enthesitis were more prevalent in women who also presented at baseline a significantly higher tender joint count (Fig.1) than men but no difference in swollen joint count.Figure 1.Longitudinal evolution of TJC68, Pain, VAS global, BRAF for men and women in the first year of PsA.All composite indices (CPDAI, DAPSA, GRACE, MDA, Psoriatic ArthritiS Disease Activity Score) showed significantly worse results in women at baseline. Women also suffered more frequently from comorbid medical conditions, fatigue and anxiety, and reported more severe limitations in function and worse quality of life.At 12 months women, despite the improvement they made, reported significantly higher levels of pain compared to men. Although MDA rates increase over time for both sexes,(Fig.2), it remained significantly more prevalent among men (19.0% vs 11.1% at inclusion,p, and 58.1% vs 35.7%,p, at T12). DAPSA was significantly higher in women at both timepoints and a significantly higher percentage of men presented remission according to DAPSA score at 12 months.Figure 2.Longitudinal evolution of composite measures for men and women in the first year of PsA.Conclusion:After 1 year of follow-up women didn’t surpass their baseline disadvantages and despite the improvement, they still present higher disease activity, more pain and lower functional capacity than men. The nature of these findings may advocate a need for sex specific adjustment of treatment strategies and evaluation in psoriatic arthritis as sex-related difference in outcome persisted over time.References:[1]Eder L, Thavaneswaran A, Chandran V, Gladman DD. Gender difference in disease expression, radiographic damage and disability among patients with psoriatic arthritis. Annals of the rheumatic diseases. 2013;72(4):578-82.[2]Orbai AM, Perin J, Gorlier C, Coates LC, Kiltz U, Leung YY, et al. Determinants of Patient-Reported Psoriatic Arthritis Impact of Disease: An Analysis of the Association with Gender in 458 Patients from 14 Countries. Arthritis care & research. 2019.Disclosure of Interests:Evangelia Passia: None declared, Marijn Vis Grant/research support from: Novartis, Pfizer – grant/research support, Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer – consultant, Laura C Coates: None declared, Anushka Soni Grant/research support from: Oxford-UCB prize fellowship, Speakers bureau: Janssen and Abbvie, Ilja Tchetverikov: None declared, Andreas Gerards: None declared, Lindy-Anne Korswagen: None declared, Marc R Kok Grant/research support from: BMS and Novartis, Consultant of: Novartis and Galapagos, Wiebo van der Graaff: None declared, Josien Veris-van Dieren: None declared, Natasja Denissen: None declared, F. Fodili: None declared, M. Starmans: None declared, Yvonne Goekoop-Ruiterman: None declared, M. van Oosterhout: None declared, Jolanda Luime: None declared

Background:Rheumatologists play an important role in the management of patients with Psoriatic Arthritis (PsA). With PsA being a multifaceted disease, it can be challenging to assess the impact of psoriatic skin symptoms, next to the musculoskeletal complaints. We have previously shown that a dermatology-specific Health-related Quality of Life (HRQoL) questionnaire provides insight into the burden of skin symptoms, in contrast to a general HRQoL questionnaire.1 When treating PsA patients, specific questions on skin symptoms are necessary in order to assess the burden of psoriasis.Objectives:To create a set of questions that can easily identify PsA patients with a high psoriasis burden in daily rheumatology clinical practice.Methods:Data from patients receiving usual care were used from the Dutch south west Psoriatic Arthritis (DEPAR) cohort, consisting of newly diagnosed PsA patients included between July 2013 and March 2020. The two dermatology-specific HRQoL questionnaires used were the Skindex-17 and Dermatology Life Quality Index (DLQI), both with a one-week recall period.First, an exploratory principal component analysis (PCA) with varimax rotation was performed on both questionnaires combined, to identify underlying latent traits. Subsequently, items were dichotomized on their median frequencies. And a 2-parameter logistic (2PL) model was fitted for each latent trait. Item characteristic curves were plotted for each latent trait. Item selection took place based on the discrimination and difficulty of the items. Per latent trait, we selected 2 to 3 items distributed far apart across the latent trait. A flowchart was made with the selected questions.Results:In total, 413 patients with completed Skindex-17 and DLQI questionnaires at baseline were included. Mean (sd) age was 50.3 (13.4) years and median (IQR) Psoriasis Area and Severity Index (PASI) score 2 (0.5-4.2). The PCA gave the best fit with two underlying clusters of questions, namely psychosocial (n=20) questions and questions regarding physical symptoms (n=7). Three questions were selected to assess psychosocial impact and two for impact of physical symptoms (Figure 1). Questions should be asked in chronological order.Figure 1.Flowchart of questions assessing psoriasis burden.Cluster 1: PsychosocialThe first question is if the patient was embarrassed by their skin condition. If answered with “never”, the patient experienced the lowest burden. When answered with “rarely/sometimes” or “often/always”, continue to the second question. Ask the patient if they tended to stay at home because of their skin condition. If answered with “never”, they experienced a higher burden. If answered with “rarely/sometimes” or “often/always”, continue to the last question. Ask the patient if their skin condition has prevented them from working or studying. If not, the patient experienced a higher burden and if answered with “yes”, they experienced the highest burden in this domain.Cluster 2: Physical symptomsFirst ask the patient how itchy, sore, painful or stinging their skin was. If they answer with “not at all”, they experienced the lowest burden. If answered with “a little/a lot/very much”, continue to the second question. Ask if their skin was irritated. If answered with “never/rarely/sometimes”, they experienced a higher burden. If answered with “often/always”, the patient experienced the highest burden in this domain.Conclusion:We have created a practical guide for rheumatologists to distinguish PsA patients with a high psoriasis burden from those with a lower burden. With a minimum of two and a maximum of five questions, both psychosocial burden of psoriasis and burden of physical symptoms can be easily identified in daily clinical practice.References:[1]Kasiem FR, Kok MR, Tchetverikov I, Wervers K, Hazes J, Luime J, et al. AB0786 Impact of psoriasis severity on Health-Related Quality of Life in early psoriatic arthritis: results from real world data, the DEPAR study. Annals of the Rheumatic Diseases. 2020;79:1691-2.Disclosure of Interests:None declared

Background:Health literacy is increasingly recognised as a critical determinant of health. While care should be tailored to the health literacy needs of each patient [1], research in primary care shows that physicians often under- or overestimate their patients’ health literacy, with socioeconomic factors playing a role [2]. Evidence in a rheumatology setting is scarce.Objectives:-To investigate discordance between health literacy of patients with rheumatic and musculoskeletal diseases (RMDs) and assessment by their treating health professional, across the nine domains of the Health Literacy Questionnaire (HLQ).-To explore whether discordance is associated with the patient’s socioeconomic background.Methods:Patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), or gout from three Dutch outpatient rheumatology clinics completed the HLQ [3]. The treating health professional (rheumatologist, physician assistant, nurse (practitioner) or resident) assessed their patient’s level for each HLQ domain, or answered “I don’t know”. Discordance per domain was calculated as the patient’s score subtracted from the professional’s score (both on a 0-10 scale). Discordance was defined as a ≥2-point difference in either direction. Adjusted multilevel multinomial regression models (ref. = no discordance) with patients clustered by health professionals were computed to test the role of socioeconomic factors (age, gender, education level, immigration background, living alone and employment status) in negative (i.e. professional scored lower) and positive (i.e. professional scored higher) discordance.Results:Of 778 patients included, 41% had RA, 34% had SpA, and 25% had gout. We observed considerable discordance across all HLQ domains (Table 1). Professionals answered “I don’t know” most often for “Having social support for health” (19.4%, domain 4). Most discordance occurred for “Critically appraising information” (42.1%, domain 5). For all HLQ domains except “Having social support for health” (domain 4), discordance was associated with socioeconomic factors. In patients with a non-Western immigration background, professionals were likely to assign lower scores than patients’ HLQ scores in six domains. Education level was an important driver of discordance in seven domains, with the direction of the association being domain-dependent. Other factors associated with discordance in multiple domains were type of rheumatic disease, comorbidities, mastery, how well the professional knew the patient, type of professional, and disease impact.Table 1.Discordance per HLQ domain (n=778)HLQ domainProfessional scored lowerNo discordanceProfessional scored higherProfessional did not known (%)1. Healthcare provider support128 (16)514 (66)126 (16)10 (1)2. Having sufficient information100 (13)528 (68)143 (18)7 (1)3. Actively managing health95 (12)461 (59)208 (27)14 (2)4. Having social support for health55 (7)397 (51)175 (22)151 (19)5. Critically appraising information78 (10)448 (58)250 (32)2 (0)6. Actively engaging with providers205 (26)500 (64)70 (9)3 (0)7. Navigating the health system115 (15)544 (70)107 (14)12 (2)8. Finding health information163 (21)492 (63)98 (13)25 (3)9. Understanding health information145 (19)511 (66)110 (14)12 (2)Conclusion:Considerable discordance between patients’ health literacy and their treating health professionals’ assessment exists across health literacy domains. In eight out of nine domains, discordance was associated with the patient’s socioeconomic background, particularly education and immigration background. Understanding and addressing the reasons for discordance between patient-reported and professional-perceived health literacy has potential to improve responsiveness to patients’ needs, promote better communication and ultimately improve care outcomes.References:[1]Bakker et al., Arthrit Care Res (2021)[2]Storms et al., BMJ Open (2019)[3]Osborne et al., BMC Public Health (2013)Disclosure of Interests:None declared

Background:The effect of inflammatory arthritis (IA) on fertility has been mainly studied in women. Multiple factors associated with lower fertility rate in women can also be present in male patients with IA (1). The fertility rate in men with IA, however, has never been studied.Objectives:To describe the fertility rate (number of biological children per individual) of men with IA.Methods:We performed a multicenter cross-sectional retrospective study conducted in eight Dutch hospitals. Men with IA (Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA) and Spondyloarthritis (SpA)) who were over 40 years old and indicated that their family size was complete were invited to participate. Men who were still planning on having biological children were excluded. Participants completed a digital questionnaire that included fertility-related questions and questions regarding their demographic and clinical information. To analyze the impact of IA on male fertility rate, patients were divided into groups according to the age at the time of their diagnosis: age41 years.Results:In total 628 participants diagnosed with IA were included. The response rate 34.87%. Information regarding their age, age at diagnosis, clinical diagnosis and number of children is presented per group in Table 1. Regarding the total number of children per man, there was a statistically significant difference between the three groups (p=41 years (1.88 {SD 1.14}). Compared to men from the general population of the Netherlands, the total number of children of men diagnosed at age>41 years was not statistically different (1.88 vs 1.80, respectively).Table 1.Participants’ basic demographic and clinical characteristics, including the number of biological children per men.All patientsIA diagnosed at age IA diagnosed at age 31-40 yearsIA diagnosed at age >41 yearsTotal, n (%)628137 (21.82)149 (23.73)342 (54.46)Age, mean (SD)57.17 (9.98)53.01 (9.96)52.76 (7.35)61.06 (9.47)Diagnosis, n (%)•iRA297 (47.29)42 (30.66)67 (44.97)188 (55.32)•AJIA10 (1.59)10 (6.25)0 (0)0 (0)•ISpA (incl. PsA)320 (50.96)90 (65.69)83 (55.70)147 (42.98)Age at diagnosis, mean (SD)41.29 (13.08)26.27 (9.15)36.99 (5.66)49.98 (9.70)Disease duration, mean (SD)15.89 (11.88)26.48 (12.57)15.70 (8.52)11.30 (9.87)Number of biological children, mean (95% CI)1.71 (1.60-1.81)1.39 (1.15-1.63)a,b1.60 (1.38-1.82)a1.88 (1.75 -2.01)a p< 0.05 compared to those diagnosed age >41 yearsb p< 0.05 compared to those diagnosed age >31-40 yearsConclusion:This is the largest study ever conducted to evaluate the impact of IA on male fertility. We demonstrated that men diagnosed with IA before and during their reproductive years have a lower fertility rate than those men diagnosed with IA after their reproductive years. Multiple mechanisms (biological and non-biological) can be responsible for this association. More research is needed to identify the causes of these lower fertility rates in men with IA.References:[1]Perez-Garcia LF, Te Winkel B, Carrizales JP, Bramer W, Vorstenbosch S, van Puijenbroek E, et al. Sexual function and reproduction can be impaired in men with rheumatic diseases: A systematic review. Semin Arthritis Rheum. 2020;50(3):557-73.Figure 1.Total number of biological children (mean and SD) per group.Acknowledgements:The authors would like to acknowledge Ron Buijs, data manager of the Department of Rheumatology of the Erasmus MC, for his technical support with regards to data collection.Disclosure of Interests:Luis Fernando Perez-Garcia Consultant of: Galapagos, Esther Röder: None declared, Robbert Goekoop: None declared, Johanna Hazes: None declared, Marc R Kok Consultant of: Novartis, Grant/research support from: Novartis, Petra Kok: None declared, Hieronymus TW Smeele: None declared, Ilja Tchetverikov: None declared, J.H. van der Kaap: None declared, Annette van der Helm - van Mil: None declared, Bouwe Krijthe: None declared, Radboud Dolhain Speakers bureau: UCB, Roche, Abbvie, Genzyme, Novartis, Consultant of: Galapagos, Grant/research support from: UCB

Background:The need to involve patient reported outcomes (PROs) in the management of rheumatoid arthritis (RA) increases, since PROs quantify patient relevant outcomes. Although PROs have been incorporated in the core-outcome sets in clinical trials, knowledge about the treatment effects on these PROs is scarce. Therefore, we performed a systematic review on the effects of disease modifying anti-rheumatic drugs (DMARDs), of any type, on relevant PRO domains mentioned in the ICHOM standard set. This might support rheumatologists and RA patients during treatment decisions.Objectives:To get insight in the treatment effects of DMARDs of any type on three PRO domains that matter to patients (pain, activity limitations and fatigue).Methods:A systematic review was performed in Embase, Medline, Web of Science, Cochrane and Google Scholar. Included were all studies that were published before August 2019 and showed DMARD treatment effects in RA on PROs that are part of the ICHOM standard set. Three Bayesian network meta-analyses were performed for the PRO domains pain, activity limitations and fatigue. Preliminary results of DMARDs (in)directly compared to placebo were visualized by forest plots using R.Results:The search strategy yielded n=5974 articles. After selection was performed by 2 independent researchers, n=70 individual articles representing n=53 studies were extracted, over the three PRO domains; pain (n=31), activity limitations (n=41) and fatigue (n=21). In all RCTs, PROs were only reported as secondary or tertiary endpoints. In figure 1, we show the effects on PROs for any type of DMARD investigated compared to placebo. Overall, DMARDs show a greater reduction in pain (standardized mean difference (SMD); -0.97 – -0.22) and most of them in activity limitations (SMD; -0.81 – 0.56). In fatigue, this clear direction is lacking (SMD; -0.86 – 3.5). csDMARDs and anti-TNF seem to perform slightly, but nog significantly, worse than other bDMARDs and tsDMARDs in the first two domains.Conclusion:Within in this systematic review we report a reduction for DMARDs of any type on the domains of pain and activity limitations compared to placebo. However, results are still preliminary and should be interpreted with care. A more comprehensive network analysis might give a more definitive answer which DMARD performs best.Figure 1.Disclosure of Interests:None declared

Background:Treatment with low-dose glucocorticoids (GCs) (≤7.5 mg prednisolone) in combination with standard care is highly effective in rheumatoid arthritis (RA), but despite 70 years of clinical experience, evidence-based information on its balance of benefit and harm is incomplete. This leads to an ongoing debate, with under- and over-use of GCs as result. The GLORIA pragmatic trial was developed to assess harm, benefit and costs of low-dose GCs added to the standard treatment of older RA patients.Objectives:The objective of this abstract is to document the baseline status and frequency of comorbid conditions in the GLORIA study population. The results of the unblinded data will be submitted as late-breaking abstract.Methods:This double-blind, randomized, placebo-controlled, multicenter trial (1) was open for patients with RA according to the 1987 or 2010 (2) criteria, age ≥65 years, and disease activity score of 28 joints (DAS28) of ≥2.6. Patients were recruited from rheumatology clinics in Germany, Hungary, Italy, The Netherlands, Portugal, Romania and Slovakia. Eligible patients were randomized to two years of treatment with daily 5 mg prednisolone or matching placebo. All other medication was allowed, except for GCs. The presented data are blinded because the database is not closed yet.Results:The population consists of 451 patients with mean disease duration 10.6 (Q1-Q3: 3-15) years. The majority (70%) is female, mean age is 72.5 (Q1-Q3: 68-76, range: 65-88) years, 66% were positive for rheumatoid factor and 56% for ACPA. Patients had a mean of 4.3 (SD 2.8) comorbidities besides RA (3.4 active) and therefore used multiple concomitant medications (3.9 (SD 3.4)) (Table 1). The most common comorbidities (provisional data of 161 patients with complete coding) in this older population are: vascular disorders (58%), musculoskeletal and connective tissue disorders (57%) and a history of surgical and medical procedures (45%). Patients were most frequently on beta blocking agents (22%, mainly metoprolol) and HMG CoA reductase inhibitors (20%, mainly simvastatin). Most patients also have an extensive history of anti-rheumatic treatment. At the start of the trial most patients (82%) were on cDMARD treatment; 15% were on bDMARDs/tsDMARDs. Almost half of the patients previously had been treated with GCs, with a mean duration of 3.4 years and a mean last dose of 4.6 mg/day.Conclusion:The baseline data shows that we have an older study population who have relatively many other comorbidities next to RA and who are almost all treated with multiple concomitant medications in addition to the study medication. Therefore, we expect to report a high adverse event rate. Research among older patients is urgently needed, but the frailty of this population as represented by the multiple comorbidities and concomitant medications have to be taken into account in the analyses and interpretation of the results.References:[1]Hartman L, Rasch LA, Klausch T, Bijlsma HWJ, Christensen R, Smulders YM, et al. Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial. Trials. 2018;19:67.[2]Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569-81.Table 1.Comorbidities and concomitant medications at baseline in the GLORIA trial.MeanSDRangeComorbidities 4.32.8 0-15 Active 3.4 Past 1.9Concomitant medications (count) 3.93.4 0-15 Beta blocking agents (%)22 HMG CoA reductase inhibitors (%)20 Platelet aggregation inhibitors (%)16 ACE inhibitors (%)12 Angiotensin II antagonists (%)11DAS28 4.521.05DAS28CRP 4.060.97HAQ (0-3) 1.20.7RA treatmentCurrent (%)Previous (%) cDMARD8492 bDMARD/tsDMARD1522 NSAID5129 Glucocorticoids 049Acknowledgements:The GLORIA project is funded by the European Union’s Horizon 2020 research and innovation programme under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886.Disclosure of Interests:None declared

Background:The effect of inflammatory arthritis (IA) on pregnancy outcomes has been studied mainly in women. Paternal older age, sperm DNA integrity and certain genetic defects have been associated with worse pregnancy outcomes (1). However, pregnancy outcomes of partners of men with IA have never been studied.Objectives:To describe the pregnancy characteristics and outcomes of partners of men diagnosed with IA.Methods:We performed a multicenter cross-sectional retrospective study conducted in eight Dutch hospitals. Men with IA (Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA) and Spondyloarthritis (SpA)) who were over 40 years old and indicated that their family size was complete were invited to participate. Participants completed a digital questionnaire that included pregnancy-related questions and questions regarding their demographic and clinical information. To analyze the impact of IA on pregnancy outcomes, pregnancies were classified into two groups; pregnancies that occurred after diagnosis of IA and before the diagnosis of IA.Results:In total 628 male participants diagnosed with IA were included. 408 men reported 897 singleton pregnancies that resulted in 794 live births. Regarding pregnancy characteristics, pregnancies conceived after diagnosis of IA had a higher mean paternal and maternal age at conception and a lower rate of spontaneous pregnancies (90.91 vs 96.60%, p=Table 1.Pregnancy characteristics and outcomes.AllpregnanciesPregnancy afterdiagnosis of IAPregnancy before diagnosis of IAP valuePregnancy characteristicsTotal number of pregnancies897220677Maternal age at conception, mean (SD)29.00 (5.00)30.69 (5.16)28.45 (4.83)pPaternal age at conception, mean (SD)31.31 (5.72)34.27 (6.08)30.49 (5.34)pSpontaneous pregnancy, n (%)854 (95.21)200 (90.91)654 (96.60)pPregnancy duration-months, median (IQR)39 (38-40)39 (38-40)39 (38-40)p=0.928Pregnancy outcomesLive births, n (%)794 (88.52)190 (86.36)604 (89.22)p=0.053Miscarriage, n (%)78 (8.70)27 (12.27)51 (7.53)pAbortion, n (%)25 (2.78)3 (1.36)22 (3.25)p=0.128*Medical indication5 (20.00)0 (0)5 (22.73)*Personal reasons20 (80.00)3 (100.00)17 (77.27)Pre-term birth149 (16.61)31 (14.09)118 (17.43)p=0.248Pregnancy complicationsNo complications during pregnancy, n (%)754 (84.34)184 (83.64)570 (84.57)p=0.741Hypertensive disorders(hypertension, pre/eclampsia), n (%)41 (4.57)8 (3.64)33 (4.87)p=0.445Gestational Diabetes Mellitus11 (1.28)2 (0.94)9 (1.38)p=0.619Growth restriction12 (1.34)1 (0.45)11 (1.65)p=0.193Conclusion:This is the largest study to describe the pregnancy characteristics and outcomes of partners of men diagnosed with IA and the first to demonstrate that paternal IA is associated with a higher risk of miscarriage. Prospective studies are needed to corroborate these findings.References:[1]Ibrahim Y, Johnstone E. The male contribution to recurrent pregnancy loss. Translational andrology and urology. 2018;7(Suppl 3):S317-S27.Acknowledgements:The authors would like to acknowledge Ron Buijs, data manager of the Department of Rheumatology of the Erasmus MC, for his technical support with regards to data collection.Disclosure of Interests:Luis Fernando Perez-Garcia Consultant of: Galapagos, Esther Röder: None declared, Robbert Goekoop: None declared, Marc R Kok Consultant of: Roche, Grant/research support from: Roche, Petra Kok: None declared, Hieronymus TW Smeele: None declared, Ilja Tchetverikov: None declared, Annette van der Helm - van Mil: None declared, J.H. van der Kaap: None declared, Bouwe Krijthe: None declared, Radboud Dolhain Speakers bureau: Abbvie, UCB, Genzyme, Novartis, Consultant of: Galapagos, Grant/research support from: UCB

Background:Medication adherence in the GLORIA trial, among elderly patients with rheumatoid arthritis, is measured with caps that register openings of the medication bottle. At each study visit, one or two medication bottles with cap (kits) are dispensed, each containing 90 capsules. Multiple steps are needed to come to a workable dataset to describe adherence.Objectives:To describe the steps that are needed to come from raw data to a workable dataset to analyze adherence data that are recorded by electronic caps.Methods:The medication bottle contains a cap with the ability to register cap openings. The raw dataset from the caps consist of an excel file with one opening event per row, recorded as date and time. One cap yields approximately 90 rows. First, the kit numbers were matched to the corresponding patient numbers, that are recorded in another excel file. Instances where two kits were dispensed were recorded with two kit numbers in one cell and need to be copied to two cells with one kit number. Second, the VLOOKUP function was used to combine dates and kit numbers. One row now contains all openings from one kit. Then, the number of days between first opening and each next opening date was calculated. A range of 90 days was made to calculate how many times the bottle was opened on each day of the 90-days period. The results were color-coded to visualize instances of zero, one or ≥two openings on a day.Results:The colored calendar matrix (Figure 1) can now be used to categorize adherence patterns.Conclusion:A monitoring cap seems a simple instrument to measure adherence. However, multiple steps and a lot of time are needed to come to a workable dataset for the study of adherence patterns.Acknowledgments:The GLORIA project is funded by the European Union’s Horizon 2020 research and innovation programme under the topic ‟Personalizing Health and Care’’, grant agreement No 634886.Disclosure of Interests:Linda Hartman: None declared, Elisa Alessandri: None declared, Reinhard Bos: None declared, Daniela Opris-Belinski Speakers bureau: as declared, Marc R Kok Grant/research support from: BMS and Novartis, Consultant of: Novartis and Galapagos, Hanneke Griep-Wentink: None declared, Ruth Klaasen: None declared, Cornelia Allaart: None declared, George Bruyn: None declared, Hennie Raterman Grant/research support from: UCB, Consultant of: Abbvie, Amgen, Bristol-Myers Sqibb, Cellgene and Sanofi Genzyme, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Nuno Gomes: None declared, Rui Pinto: None declared, Thomas Klausch: None declared, WIllem Lems Grant/research support from: Pfizer, Consultant of: Lilly, Pfizer, Maarten Boers: None declared

Background:The prevalence of limited health literacy (i.e. cognitive and social resources of individuals to access, understand and apply health information to promote and maintain good health) in the Netherlands is estimated to be over 36% [1]. Access to and outcomes of rheumatological care may be compromised by limited patient health literacy, yet little is known about how to address this, thus action is required. As influencing individual patients’ health literacy in the rheumatology context is often unrealistic, it is paramount for the health system to be tailored to the health literacy needs of its patients. The OPtimising HEalth LIteracy and Access (Ophelia) process offers a method to inform system change [2].Objectives:Following the Ophelia approach:a. Identify health literacy profiles reflecting strengths and weaknesses of outpatients with RA, SpA and gout.b. Use the health literacy profiles to facilitate discussions on challenges for patients and professionals in rheumatological care and identify possible solutions the health system could offer to address these challenges.Methods:Patients with RA, SpA and gout attending outpatient clinics in three centres in the Netherlands completed the Health Literacy Questionnaire (HLQ) and questions on socio-demographic and health-related characteristics. Hierarchical cluster analysis using Ward’s method identified clusters based on the nine HLQ domains. Three researchers jointly examined 24 cluster solutions for meaningfulness by interpreting HLQ domain scores and patient characteristics. Meaningful clusters were translated into health literacy profiles using HLQ patterns and demographic data. A patient research partner confirmed the identified profiles. Patient vignettes were designed by combining cluster analyses results with qualitative patient interviews. The vignettes were used in two two-hour co-design workshops with rheumatologists and nurses to discuss their perspective on health literacy-related challenges for patients and professionals, and generate ideas on how to address these challenges.Results:In total, 895 patients participated: 49% female, mean age 61 years (±13.0), 25% lived alone, 18% had a migrant background, 6.6% did not speak Dutch at home and 51% had low levels of education. Figure 1 shows a heat map of identified health literacy profiles, displaying the score distribution per profile across nine health literacy domains. Figure 2 shows an excerpt of a patient vignette, describing challenges for a patient with profile number 9. The workshops were attended by 7 and 14 nurses and rheumatologists. Proposed solutions included health literacy communication training for professionals, developing and improving (visual) patient information materials, peer support for patients through patient associations or group consultations, a clear referral system for patients who need additional guidance by a nurse, social worker, lifestyle coach, pharmacist or family doctor, and more time with rheumatology nurses for target populations. Moreover, several system adaptations to the clinic, such as a central desk for all patient appointments, were proposed.Conclusion:This study identified several distinct health literacy profiles of patients with rheumatic conditions. Engaging with health professionals in co-design workshops led to numerous bottom-up ideas to improve care. Next steps include co-design workshops with patients, followed by prioritising and testing proposed interventions.References:[1]Heijmans M. et al. Health Literacy in the Netherlands. Utrecht: Nivel 2018[2]Batterham R. et al. BMC Public Health 2014, 14:694Disclosure of Interests:Mark Bakker: None declared, Polina Putrik: None declared, Jany Rademakers Speakers bureau: In March 2017, Prof. Dr. Rademakers was invited to speak about health literacy at the “Heuvellanddagen” Conference, hosted by Janssen-Cilag., Mart van de Laar Consultant of: Sanofi Genzyme, Speakers bureau: Sanofi Genzyme, Harald Vonkeman: None declared, Marc R Kok Grant/research support from: BMS and Novartis, Consultant of: Novartis and Galapagos, Hanneke Voorneveld: None declared, Sofia Ramiro Grant/research support from: MSD, Consultant of: Abbvie, Lilly, Novartis, Sanofi Genzyme, Speakers bureau: Lilly, MSD, Novartis, Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Richard Osborne Consultant of: Prof. Osborne is a paid consultant for pharma in the field of influenza and related infectious diseases., Roy Batterham: None declared, Rachelle Buchbinder: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department)

Background:Adherence is a serious problem in treatment of inflammatory diseases. To measure adherence, caps that record medication bottle openings may be superior to capsule counts (1). In the ongoing two-year GLORIA trial on the addition of low-dose (5 mg) prednisolone or placebo to standard of care in elderly patients (65+ years) with rheumatoid arthritis, adherence was measured in both ways during the whole trial.Objectives:To describe adherence patterns, and to compare adherence as assessed with adherence caps and with capsule counts in the GLORIA trial.Methods:The recorded adherence patterns of patients (blinded for treatment group) were classified according to descriptive categories. Overall adherence according to number of bottle openings was compared with adherence according to the capsule count. Good adherence was defined as 80%: i.e. for caps 80% of days one opening recorded, and for counts less than 20% of prescribed tablets returned at the subsequent visit. Each patient has a maximum of 8 periods of 90 days.Results:Trial inclusion has closed in 2018 at 452 patients; the current dataset contains adherence data of 385 patients. Mean number of recorded 90-day periods per patient was 4 (range 1-8). Based on capsule counts over all periods, 90% of the patients met the 80% threshold of adherence; based on cap data only 31% met this criterion.The four adherence patterns are shown in a calendar matrix, with yellow for zero, green for one and blue for ≥two openings on a day (Figure 1). Bottles were supposed to be opened once a day.Patients were categorized according to the opening pattern seen in at least 50% of assessed periods:32% non-use(26% stable use(≥80% of the days 1 opening);40% irregular use(different adherence patterns, in or between periods);2% weekly use(1 opening per week).Conclusion:In our trial of elderly rheumatoid arthritis patients, patients appeared to be mostly adherent according to conventional capsule counts. Results from adherence caps were highly discrepant with the capsule counts, with patterns suggesting patients did not use the bottle for daily dispensing, despite specific advice to do so.References:[1] El Alili M, Vrijens B, Demonceau J, Evers SM, Hiligsmann M. A scoping review of studies comparing the medication event monitoring system (MEMS) with alternative methods for measuring medication adherence. Br J Clin Pharmacol 2016;82:268-79.Acknowledgments:The GLORIA project is funded by the European Union’s Horizon 2020 research and innovation programme under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886.Disclosure of Interests:Linda Hartman: None declared, Sabrina Paolino: None declared, Reinhard Bos: None declared, Daniela Opris-Belinski Speakers bureau: as declared, Marc R Kok Grant/research support from: BMS and Novartis, Consultant of: Novartis and Galapagos, Hanneke Griep-Wentink: None declared, Ruth Klaasen: None declared, Cornelia Allaart: None declared, George Bruyn: None declared, Hennie Raterman Grant/research support from: UCB, Consultant of: Abbvie, Amgen, Bristol-Myers Sqibb, Cellgene and Sanofi Genzyme, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Nuno Gomes: None declared, Rui Pinto: None declared, Thomas Klausch: None declared, WIllem Lems Grant/research support from: Pfizer, Consultant of: Lilly, Pfizer, Maarten Boers: None declared

Background:Psoriasis is an important feature of psoriatic arthritis (PsA). Psoriasis itself is known to have a significant impact on Health-related Quality of life (HRQoL)1, however its role within PsA is less well understood. In daily practice, assessment of psoriasis may not always be a priority for rheumatologists, having been trained to focus on articular involvement. In order to assess whether psoriasis deserves more attention from rheumatologists, the aim of this study is to evaluate the influence of psoriasis on HRQoL in early PsA patients.Objectives:To describe the evolution of psoriasis severity during the first year of follow up in patients with early PsA and to evaluate the impact of psoriasis severity on HRQoL.Methods:Real world data were used from the Dutch south west Psoriatic Arthritis cohort (DEPAR) study, consisting of newly diagnosed PsA patients included between July 2013 and February 2019. Psoriasis severity was assessed using the Psoriasis Area and Severity Index (PASI) and categorized in: no psoriasis (PASI 0), mild psoriasis (PASI12). Musculoskeletal disease severity was measured with the Disease Activity in PSoriatic Arthritis (DAPSA) score as contrast for psoriasis severity. DAPSA was categorized in: remission (REM[DAPSA≤4]), low disease activity (LDA[DAPSA≤14]), moderate disease activity (MDA[DAPSA≤28]) and high disease activity (HDA[DAPSA>28]).2General HRQoL was assesed with the Short-Form 36 (SF-36[Physical component scale and Mental component scale]). Skin-specific HRQoL was measured with the Skindex-17 (psychosocial scale and symptoms scale).Results:In total, 435 patients were included. Mean (sd) age was 49.7 (13.4) years and 53% (n=229) was male. Psoriasis severity does not fluctuate much over the course of the first year and the majority of patients had mild psoriasis (Figure 1). HRQoL worsened with increasing psoriasis severity, when measured by the Skindex17. This reduction in HRQoL was not seen when measured with the SF-36 (Figure 2).Figure 1.Psoriasis severity categories during the first year of follow up. No psoriasis (PASI 0), mild psoriasis (PASI12).Figure 2.A, B: Median Skindex17 psychosocial score and symptoms score per psoriasis severity category and DAPSA category at baseline. C,D: Mean SF36 Physical component scale (PCS) score and Mental component scale (MCS) score per psoriasis severity category and DAPSA category at baseline. No psoriasis (PASI 0), mild psoriasis (PASI12). REM (DAPSA28)Conclusion:In early PsA patients, psoriasis severity is mostly mild, but considerably impacts HRQoL when measured using a skin specific questionnaire. For optimal management of PsA patients, we therefore recommend rheumatologists to additionally acquire information on the degree of psoriatic involvement. In our opinion, this information is valuable for the adequate assessment of HRQoL.References:[1]Strober B, Greenberg JD, Karki C, Mason M, Guo N, Hur P, et al. Impact of psoriasis severity on patient-reported clinical symptoms, health-related quality of life and work productivity among US patients: real-world data from the Corrona Psoriasis Registry. BMJ Open. 2019;9(4):e027535.[2]Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016;75(5):811-8.Disclosure of Interests:Fazira R. Kasiem: None declared, Marc R Kok Grant/research support from: BMS and Novartis, Consultant of: Novartis and Galapagos, Ilja Tchetverikov: None declared, Kim Wervers: None declared, Johanna Hazes: None declared, Jolanda Luime: None declared, Marijn Vis Grant/research support from: Novartis, Pfizer – grant/research support, Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer – consultant

Effective treatment for Sjögren's syndrome (SS) might be developed locally by introducing genes encoding cytokines, which are potentially anti-inflammatory, or by introducing a cDNA encoding a soluble form of a key cytokine receptor, which can act as an antagonist and decrease the availability of certain cytokines, such as soluble tumour necrosis factor alpha receptors. Currently, the preferred choice of viral vector for immunomodulatory gene transfer is recombinant adeno-associated virus. The use of gene transfer to help determine the pathophysiology and to alter the course of the SS-like disease in the NOD mouse model can ultimately lead to the development of new treatments for managing the salivary component in patients with SS.

Background Psoriatic arthritis (PsA) is a disease with musculoskeletal and skin inflammation (psoriasis). Attempts are being made to develop comprehensive disease measures to capture global disease activity. However very little is known on how much psoriasis actually affects quality of life (QOL) in patients with PsA. Objectives In this study we aim to determine to what extent psoriasis affects quality of life in incident Psoriatic Arthritis patients. Methods Data collected at baseline in the Dutch south west Psoriatic Arthritis Registry (DEPAR) study were used. The DEPAR includes newly diagnosed PsA patients from 8 hospitals in the South-West of the Netherlands. PsA core measurements were collected: Swollen and Tender join count (66/68), enthesitis (LEI and MASES), dactylitis (LDI) and psoriasis (PASI). In addition 3 patient reported measures of quality of life were administered. Short Form-36 (SF-36) is a self-administered 36-item health survey questionnaire. The items are assigned to eight scales grouped in two factors: physical component summary (PCS) and mental component summary (MCS, score 0–100). Skindex-17 is a self-administered 17-item dermatology questionnaire that explores functioning, emotions and symptoms in a Symptoms Subscale (SS; range 0–10) and a Psychosocial Subscale (PS; range 0–24).The DLQI is a self-administered 10-item questionnaire, score 0–30 with higher scores resulting in poorer quality of life. It covers Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships and Treatment Results In total 281 patients were included: mean age was 50.6 (SD 13.6) and 50.5% were male. In terms of arthritis subtypes, 56 (20%) had mono-arthritis, 108 (39%) oligo-arthritis, 80 (29%) poly-arthritis and 35 (12%) were diagnosed with axial disease, dactylitis or enthesitis only. The Median PASI score was 2.3, ranging from 0 to 22.5. Divided in PASI categories (1) this resulted for 12% in no skin disease, 72% mild (>0–7), 11% moderate (7–12) and 5% had severe (>12) psoriasis. Median PASI scores were different for mono, oligo to polyarthritis group: 2.7 (0–12.3), 3.4 (0–22.5) and 4.4 (0–21). Skin related quality of life measured by DLQI showed a median 1 (QR 0–5) and the two subscales of the skindex resulted in a median SS 4 (IQR 2–6) and a PS of 2 (IQR 0–8), and a SF-36 PCS of 40.3 (8.3) and SF-36 MCS of 47.7 (10.4).(table 1) Comparing none and mild psoriasis to moderate and sever psoriasis resulted in median scores for DLQI: 1 vs 5 (p Conclusions Skin involvement in incident Psoriatic Arthritis is in the majority of patients mild with median PASI score of 2.3. About 15% suffered from moderate to severe psoriasis. Skin quality of life measures showed poorer health states for these patients, which was also reflected in the emotional role and bodily pain subscale of more generic QOL questionnaire: SF-36. Disclosure of Interest None declared

Background To decrease burden of disease of rheumatoid arthritis (RA) we need to identify patients at risk for RA as early as possible, preferably as no clinical apparent synovitis could be detected yet. Previous studies suggest that this should be in the arthralgia phase or even before that. Up to now it has been fairly difficult to identify those arthralgia patients who develop inflammatory arthritis (IA), but recent studies in ultrasound (US) suggest that earlier detection is possible [1]. Objectives We aim to identify which arthralgia patients will develop clinical apparent IA within a year using US to detect subclinical synovitis at first consultation. Methods In a multi-centre prospective cohort study we followed arthralgia patients with ≥2 painful joints of hands, feet or shoulders without clinical apparent synovitis. Patients had a symptom duration of Results In total, 196 patients were included of whom 154 completed the 12 months follow-up. At baseline 72 (38%) arthralgia patients had US synovitis and in 29 (15%) patients a positive PD signal was detected. At 12 months follow-up 36 (23%) patients had developed IA of whom 22 patients initiated DMARD treatment. Table 1 shows baseline characteristics of cases and non-cases and the results of the univariate analysis. Strongest variables were ACPA, RF, morning stiffness >30 minutes and PD signal. In the multivariate logistic regression positive ACPA (OR 4.56: 95% CI 1.26–16.46) and the presence of PD signal (OR 5.79: 95% CI 1.75–19.19) at baseline were associated with the development of IA during one year follow-up. Conclusions In this early arthralgia cohort 38% of patients showed US synovitis at baseline. At 12 months 23% of the patients developed IA. In a multivariate analysis positive PD signal and positive ACPA were significantly associated with the development of IA after one year. References Colebatch AN, Edwards CJ, Ostergaard M, van der Heijde D, Balint PV, D9Agostino MA, et al. EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis. Ann Rheum Dis. 2013 Jun;72(6):804–14. Disclosure of Interest None declared

Background Tendon complaints are common in both healthy adults and patients with psoriatic arthritis (PsA). Ultrasound (US) could be used to investigate whether these are located at the enthesis and of inflammatory origin, as it is able to detect structural changes and inflammatory changes using Power Doppler. Objectives We aim to describe the difference in ultrasound abnormalities in the entheses of patients with recently diagnosed PsA, patients with established PsA and young healthy volunteers (20–30 years). using the MASEI US score Methods Consecutively newly diagnosed PsA patients participating in the Dutch south west Psoriatic Arthritis Registry (DEPAR), patients with >2 years PsA and healthy volunteers (aged 20–30 years) were asked to participate. An ultrasound was performed by one examiner unaware of clinical findings using an Esoate Mylab 60 (probe LA-435 and LA-523). The triceps, quadriceps, proximal and distal patellar and Achilles tendon insertion, plantar fascia (i.e. the locations of the Madrid Sonographic Enthesis Index; MASEI) and the tendon insertion at the lateral epicondyle of the elbow were investigated (1). In each location structural changes, erosions, calcifications, increased thickness and Power Doppler signal and is some locations bursitis were evaluated, resulting in a total score (range 0–158). Results In total, 25 newly diagnosed PsA patients (A), 25 established PsA patients (B) and 25 healthy volunteers (C) participated. The median of the MASEI+ score was for A 18 (IQR 15–30), for B 22 (IQR 15–27) and for C 10 (IQR 5–15) (Table 1). Of note, the reference values for thickness of the Quadriceps tendon at the superior pole (6.1 mm), the inferior pole (4.0 mm) and the insertion at the tuberosity of the tibia (4.0 mm) were exceeded by 50%, 58% and 70% of the entheses of healthy volunteers (50 tendons). Also the degree of Power Doppler signal varied from one spot of signal to a confluent signal in large section of the enthesis, suggesting different levels of inflammation or possibly even false-positive findings. The images were re-evaluated for PD signal (assigning 1 point for one spot of signal, 1.5 for 2 or 3 spots, 2 for confluent small area or 3 points for confluent large area). When excluding increased thickness of knee entheses and using the re-evaluated PD scores the median MASEI was resp. 13 (IQR 10–22.5), 13.5 (IQR 9.5–18) and 3 (IQR 1.5–8) (Table 1). Conclusions US structural changes and inflammation in the entheses are common in both early and established PsA patients using the MASEI. In healthy young adults US enthesitis was only observed around the knee. MASEI ultrasound score differentiated PsA patients from healthy volunteers when dropping the knee tendon enthesis thickness and applying a refined Power Doppler score. Our findings need to be confirmed in a larger cohort of healthy controls and patients. References de Miguel E, Cobo T, Munoz-Fernandez S, Naredo E, Uson J, Acebes JC, et al. Validity of enthesis ultrasound assessment in spondyloarthropathy. Ann Rheum Dis. 2009;68(2):169–74. Disclosure of Interest None declared

Background Acute anterior uveitis (AAU) is common in ankylosing spondylitis (AS) (1). Golimumab, a tumor necrosis factor alpha (TNF-α) blocker, has proven to be effective in the treatment of AS (2). We have shown earlier that treatment with adalimumab, another TNF-α blocker, leads to a significant decrease in the recurrence rate of AAU (3) in AS. At present, the effect of golimumab on the recurrence rate of AAU in AS is unknown. Objectives To investigate the effect of golimumab treatment on the recurrence rate of AAU attacks in AS patients. Methods Consecutive AS patients were enrolled who all fulfilled the 1984 Modified New York criteria, and fulfilled the criteria for initiating treatment with a TNF-α blocker in the Netherlands. All patients were treated with golimumab 50mg once a month for 12 months. During treatment, all occurring AAU attacks were assessed. The historic presence of AAU attacks was assessed from the year before baseline for non-biological treated patients, or the year before the first treatment with a TNF-α blocker in case of a switch from another TNF-α blocker to golimumab. Disease activity was measured with the Ankylosing Spondylitis Disease Activity Score – C-reactive protein (ASDAS). Response to treatment was assessed with the ASAS-20. Results In total, 93 patients (65% male) were evaluable as per protocol, with a mean age of 44±13 years and a median disease duration of 7 (0–53) years. Fifty-one patients (55%) were TNF-α blocker naive. Median ASDAS score at baseline was 3.1 (0.7–5.5), which decreased to 1.9 (0.1–5.1) at 12 months. ASAS-20 response was achieved by 36% of patients at month three (p Six patients (7%) had a prior history of AAU with a total of nine attacks in the year prior to the first TNF-α blocker use (9.8/100 patient years). During golimumab treatment, the rate of recurring AAU attacks was reduced to two new attacks (2.2/100 patient years), a significant reduction of 78% (p Conclusions Treatment of AS patients with golimumab leads to a significant decrease in disease activity. Simultaneously, the rate of recurring AAU attacks decreased significantly during golimumab treatment. References Stolwijk C, van TA, Castillo-Ortiz JD, Boonen A. Prevalence of extra-articular manifestations in patients with ankylosing spondylitis: a systematic review and meta-analysis. Ann Rheum Dis 2015 Jan;74(1):65–73. Inman RD, Davis JC, Jr., Heijde D, Diekman L, Sieper J, Kim SI, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum 2008 Nov;58(11):3402–12. Van Denderen JC, Visman IM, Nurmohamed MT, Suttorp-Schulten MS, van der Horst-Bruinsma IE. Adalimumab significantly reduces the recurrence rate of anterior uveitis in patients with ankylosing spondylitis. J Rheumatol 2014 Sep;41(9):1843–8. Disclosure of Interest S. Heslinga: None declared, M. Nurmohamed: None declared, A. Gerards: None declared, E. Griep: None declared, C. Koehorst: None declared, M. Kok: None declared, A. Schilder: None declared, M. Verhoef Employee of: Merck Sharp & Dohme the Netherlands, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA., I. Van der Horst-Bruinsma Grant/research support from: This study was funded by Merck Sharp & Dohme the Netherlands, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Background Psoriatic Arthritis (PsA) is a multi-features disease requiring disease activity measures that capture not only joint disease, such as the Composite Psoriatic Disease Activity Index (CPDAI) and the Psoriatic Arthritis Disease Activity Score (PASDAS). Although both are well validated in clinical trials, little data exists on their evolvement in daily clinical care. Objectives to describe the longitudinal evolvement of CPDAI and PASDAS and its associations with demography, disease, and DMARDs. Methods Newly diagnosed consecutive PsA patients were recruited in 8 hospitals in the Netherlands from August 2013 to November 2015. Demographic and disease characteristics were registered. Data was analysed in the first 3 months by linear regression and over 12 months using linear mixed model with random intercept for CPDAI (0–15) and PASDAS (0–10) Results In November 2015 281 patients had had a baseline assessment, of which 234, 198, 157 and 129 had had resp. a 3, 6, 9 and 12 month assessment. The mean age was 50.6 (SD 13.6) and 50.5% were male. In terms of arthritis subtypes, 56 (20%) had monoarthritis, 108 (39%) oligoarthritis, 80 (29%) polyarthritis and 35 (12%) were diagnosed with axial disease, dactylitis or enthesitis only. PASDAS evolved from a mean of 4.0 points (SD 1.2, n=174) at baseline, to 3.3 (SD 1.1, n=160) at 3 months, and 2.6 (SD 1.1, n=94) at 12 months. CPDAI evolved from 5.5 (SD 2.1, n=229), to 4.4 (SD 2.0, n=213) to 2.97 (SD 1.8, n=113) resp. Associations and their course over time are described in table 1. In summary: MTX had a lowering effect on both the CPDAI and PASDAS in the multivariate analysis, while baseline scores and disease duration had a raising effect. Higher baseline PASDAS and CPDAI values in the multivariate analysis were associated with being female, the presence of oligo- or polyarthritis and tender enthesis, for CPDAI also with the presence of morning stiffness. Similar results were observed in the 3-months linear regression. Conclusions PASDAS and CPDAI decrease over time associated with the use of Methotrexate, while higher baseline values and longer disease duration affected this negatively. Disclosure of Interest None declared

Background Little data is available on quality of life in newly diagnosed psoriatic arthritis (PsA) patients and its relation to the extent of the disease. Objectives To describe quality of life in newly diagnosed PsA related to the extent of the disease as defined by the number of swollen joints and the presence or absence of tender enthesis. Methods Baseline data of consecutively recruited incident PsA patients was used from the Dutch south west Psoriatic Arthritis Registry (DEPAR) study between August 2013 to November 2015. Health-related quality-of-life (HRQoL) was assessed by the 8 subscales of the Short-Form 36 (SF-36) questionnaire (0–100, higher score represents a better HRQL) and the PsA-specific quality-of-life (PsAQoL) questionnaire (0–20, lower score represents a better HRQL). Patients were classified in the three arthritis subtypes (i.e. mono-, oligo- or polyarthritis) based on evaluation of the rheumatologist. A tender enthesis was defined as having at least one tender enthesis using the Leeds Enthesitis Index (LEI) and Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Results 209 patients with arthritis at time of inclusion completed the SF-36 questionnaire. Average age was 51.4 years (SD 13.7) and 55% were male. Of these patients 49 had monoarthritis, 92 oligoarthritis and 68 polyarthritis. At least one tender enthesis was present in 45%, 38% and 53% of the patients. Mean scores of the subdomains in the SF-36 were similar across the different arthritis-groups, with better scores for monoarthritis compared to oligo and polyarthritis. However, when separating the groups based on the presence of a tender enthesis HRQoL decreased substantially for all groups across all subdomains of the SF-36, with a mean difference of 15 points (Figure 1). Mean scores of all subdomains were significantly lower in the tender enthesis group (n=106) compared to the non-tender enthesis group (n=131). Comparable results were observed for the PsAQoL scores (mono: 7.09 (SD 6.24) vs. 2.15 (SD 2.85); oligo: 7.11 (5.21) vs 4.18 (5.65) and 8.52 (6.04) vs 2.16 (2.90) Conclusions Stratifying the HRQoL for the presence of tender enthesis, present in about half of newly diagnosed PsA patients, showed lower levels of health-related quality-of-life across both physical and mental scales, independent of arthritis classification, emphasizing the importance of the enthesis in PsA. Disclosure of Interest None declared

Background Psoriatic arthritis (PsA) is the second most common chronic arthritis. The CASPAR criteria are used to classify patients as having PsA for scientific research. 1 Currently there are no diagnostic criteria for PsA. The Dutch South-West Psoriatic Arthritis Registry (DEPAR) includes patients newly diagnosed with PsA. The diagnosis is made at the discretion of the rheumatologist. In this abstract we will report the characteristics of new PsA patients in daily practice. Objectives To investigate the characteristic of patients newly diagnosed with PsA in daily clinical practice. Methods The Dutch South-West Psoriatic Arthritis Registry (DEPAR) is prospective cohort study for newly diagnosed patients with PsA. The DEPAR is hosted by CICERO a collaboration of 11 hospitals including one academic hospital in the South West Part of the Netherlands. Patients with newly diagnosed PsA are included and followed for 2 years at regular intervals (0,3,6,9,12,18 and 24 months). The diagnosis of PsA is made at the discretion of the treating rheumatologist. At baseline data is recorded on demographics, comorbidity, medication use, medical history, family history, work, quality of life and Disease activity. Results The aim is to include 500 patients; this abstract describes the characteristics of the currently included 149 patients. (table 1) Fifty percent of patients are male with a mean (SD) age of 50,1 (12,8) years and have a median of 3 swollen joints (1-20) at presentation. The percentage of patients with polyarticular, oligoarticular and monoarticular disease was 35, 40 and 25 percent respectively. Conclusions In our cohort most patients presented with a mild disease activity as measured by swollen and tender joint count, low PASI score and subsequently a low CPDAI score with only 3.2 percent in the severe range. In our region, a long standing practice of use of early arthritis clinics may have contributed to early referral of the patients and as a consequence, low disease activity state at the time of presentation. It may also be due to the fact that in daily practice, physicians tend to diagnose more patients with PsA than when using the CASPAR classification criteria. Also a majority of patients presented with oligo-/mono articular disease instead of polyarticular disease, which is studied most frequent in clinical trials. The use of DMARDs in our group of patients even with oligoarticulair disease shows the adaptation of early aggressive treatment strategies as used in rheumatoid arthritis and as such underlines the need of studies to estimate the effectiveness of such approach in daily practice. References Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54:2665–73. Disclosure of Interest None declared

Background Current pharmacological treatment options of hand osteoarthritis (hand OA) are limited. Hydroxychloroquine (HCQ) has been used successfully in the treatment of mild rheumatoid arthritis and other auto-immune diseases for many years and is believed to be beneficial in hand OA as well. Objectives The main objective was to study the symptom modifying effect of HCQ in primary hand OA Methods We conducted a randomized, double blind, placebo controlled multi center trial in which patients ≥40 years of age, with primary hand OA according to the ACR classification criteria were included. Patients with ≥1 hand joint with a Kellgren and Lawrence grade 4 were excluded. Hand pain symptoms, independent of level of severity, had to be present for at least one year. Patients were randomly assigned to receive either hydroxychloroquine 400 mg once a day or placebo during a treatment period of 24 weeks. Paracetamol was used as rescue medication and patients were allowed to continue all comedication except NSAIDs during the study. If patients were using NSAIDs, inclusion was allowed after a wash out period of 1 week. The primary outcome was decrease of hand pain in the previous 24 hours on a 100 mm visual analogue scale (VAS) at the end of the study. Secondary outcomes included change in total score of the Australian Canadian Hand Osteoarthritis Index (AUSCAN) and the Arthritis Impact Measurement Scale 2 SF (AIMS2-SF) at the end of the study. Results Two hundred and two patients were included from July 2010 till December 2013. Six patients who were lost to follow up at an early stage of the study (i.e. no data at any time point), were excluded from the analysis. An intention to treat analysis was performed on the remaining 196 patients (HCQ n=98, placebo n=98). No differences were seen in baseline characteristics between the groups: 86% of the patients were female, the mean age was 57 years. At baseline the median (25th -75th percentile) VAS pain was 45 mm (26-60) in the HCQ group and 50 mm (25-63) in the placebo group. The mean (SD) total AUSCAN score was 5.2 (1.9) in the HCQ group and 5.0 (1.9) in the placebo group (0 - 10 scale). The mean (SD) total AIMS2-SF score was 3.7 (1.2) in the HCQ group and 3.9 (1.2) group (0 - 10 scale). After 24 weeks the median (25th -75th percentile) VAS pain was 36 mm (16-58) and 48 mm (23-62) in the HCQ and placebo groups respectively. The decreases in pain were not statistically significant within the groups. Also, no statistically significant difference was seen between the intervention and placebo group at any time point (t =0, 6, 12, 24 weeks) for VAS pain scores, AUSCAN total and subscales or AIMS-SF2 outcomes. Conclusions This study shows that 24 weeks of treatment with HCQ in symptomatic hand OA did not reduce pain when compared to placebo. Also, no effect was observed in change of AUSCAN total and subscales scores or AIMS2-SF scores between both treatment groups. These results suggest that HCQ should not be prescribed in patients with primary hand OA with mild to moderate pain symptoms. Further investigation is required to determine the efficacy of HCQ in other hand OA phenotypes. Disclosure of Interest None declared