Search

In this review article four clinical comparative studies in axial spondylarthritis (axSpA) are presented and discussed. SURPASS as the only head-to-head study investigated the effect of adalimumab biosimilar disease-modifying antirheumatic drug (bsDMARD) or secukinumab on radiographic progression over a time period of 2 years. Overall, the radiographic progression of the spine was low and no significant difference between adalimumab bsDMARD or secukinumab was noted. The three other studies were not constructed as direct head-to-head studies but compared the efficacy of non-steroidal antirheumatic drugs (NSARD) with and without simultaneous treatment with biological DMARDs (bDMARD). The CONSUL study showed no statistically significant difference in the delay of radiographic progression of the spine over 2 years in radiographic axSpA (r-axSpA) patients, who underwent either combined treatment with golimumab and celecoxib or treatment with golimumab alone over 2 years. The ESTHER study showed that patients with early axSpA active inflammatory lesions, which were detected by whole-body magnetic resonance imaging (MRI), showed a significantly greater improvement under treatment with etanercept than those treated with sulfasalazine. The INFAST study showed that patients with early active axSpA who received a combined treatment of infliximab and naproxen, achieved a clinical remission twice as frequently as those who only received naproxen. Therefore, for the endpoint of radiological progression no difference could be shown in the inhibition of radiological progression between the mechanisms of action investigated. The comparative data for the endpoint of clinical efficacy showed that patients with bDMARDs showed a clearly better response to treatment than patients with NSAR or conventional synthetic DMARDs (csDMARD)., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Global health (GH) and health-related quality of life are patient priorities in axial spondyloarthritis (axSpA). Our objective was to assess the relative importance of disease-related factors including disease activity, and patient-related factors including comorbidities, to explain GH in axSpA. Post hoc cross-sectional analyses of 4 sets (COMOSPA, PERSPA, COMEDSPA, and DESIR) of patients fulfilling ASAS criteria for axSpA. GH was assessed through the ASAS Health Index (ASAS-HI) or the EuroQoL-5D-3L (EQ-5D). Disease-related factors included disease activity (ASDAS, psoriasis, arthritis, enthesitis, and CRP), disease duration, diagnostic delay, bamboo spine, and treatment. Non-disease-related factors included sociodemographic characteristics, comorbidities and chronic widespread pain. Multivariable logistic and linear regressions and partial variances (R 2 ) were applied to identify independent determinants of GH. In 6064 patients (range 284-2756 across datasets), mean age ranged 38.9-45.8 years, 51-68% were male. GH was generally moderate: median ASAS-HI ranged 5.0-7.0. GH was explained by ASDAS (range of odds ratios, OR, 2.60-4.48) and chronic widespread pain (range of OR 2.19-8.39); other determinants included comorbidities and sociodemographic characteristics. Only 47-57% of the total variance in GH could be explained by the models; disease activity (partial variance, 16-26%) and chronic widespread pain (partial variance 12-15%) were the key contributing variables. A wide range of disease and non-disease-related variables usually collected in studies could only explain 47-57% of the variability in GH. Among these, disease activity and chronic widespread pain were most relevant and of similar magnitude of importance. These findings will be helpful for shared decision-making., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Spinal radiographic progression is an important outcome in radiographic axial spondyloarthritis (SpA). The objective of the phase IIIb SURPASS study was to compare spinal radiographic progression in patients with radiographic axial SpA treated with secukinumab (interleukin-17A inhibitor) versus adalimumab biosimilar (Sandoz adalimumab [SDZ-ADL]; tumor necrosis factor inhibitor)., Methods: Biologic-naive patients with active radiographic axial SpA, at high risk of radiographic progression (high-sensitivity C-reactive protein [hsCRP] ≥5 mg/L and/or ≥1 syndesmophyte[s] on spinal radiographs), were randomized (1:1:1) to secukinumab (150/300 mg) or SDZ-ADL (40 mg). The proportion of patients with no radiographic progression (change from baseline [CFB] in modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] ≤0.5) on secukinumab versus SDZ-ADL at week 104 (primary endpoint), mean CFB-mSASSS, proportion of patients with ≥1 syndesmophyte(s) at baseline with no new syndesmophyte(s), and safety were evaluated., Results: Overall, 859 patients (78.5% male, mSASSS 16.6, Bath Ankylosing Spondylitis Disease Activity Index 7.1, hsCRP 20.4 mg/L, and 73.0% with ≥1 syndesmophyte[s]) received secukinumab 150 mg (n = 287), secukinumab 300 mg (n = 286), or SDZ-ADL (n = 286). At week 104, the proportion of patients with no radiographic progression was 66.1%, 66.9%, and 65.6% (P = not significant, both secukinumab doses) and mean CFB-mSASSS was 0.54, 0.55, and 0.72 in secukinumab 150 mg, secukinumab 300 mg, and SDZ-ADL arms, respectively. Overall, 56.9%, 53.8%, and 53.3% of patients on secukinumab 150 mg, secukinumab 300 mg, and SDZ-ADL, respectively, with ≥1 syndesmophyte(s) at baseline did not develop new syndesmophyte(s) by week 104. There were no unexpected safety findings., Conclusion: Spinal radiographic progression over two years was low with no significant difference between secukinumab and SDZ-ADL arms. The safety of both treatments was consistent with previous reports., (© 2024 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objective: Define the prevalence and location of inflammatory and structural lesions on magnetic resonance imaging (MRI) in patients with rheumatoid arthritis (RA) and radiographic axial spondyloarthritis (r-axSpA) with neck pain as leading clinical symptom., Methods: Patients with diagnosis of RA and r-axSpA were consecutively included if they had chronic (> 3 months) neck pain. Clinical assessment, neck pain questionnaires and MRIs of the cervical spine (CS) were performed., Results: 107 patients (59 RA and 48 r-axSpA) were included. While there was no difference in the Northwick-Park-Neck-Pain-questionnaire, patients with RA reported higher neck pain compared to r-axSpA on a numeric rating scale (5.0 ± 3.6 vs. 3.0 ± 3.1; p = 0.003). Inflammatory lesions occurred predominantly in the craniocervical area in RA and in the lower CS segments in r-axSpA. Bone marrow edema (BME) was more frequent in axSpA (BME-score axSpA/RA: 0.35vs0.17; p < 0.001) while synovitis was visible in both but was more prevalent in RA (synovitis-score axSpA/RA: 0.02vs0.1; p < 0.001). BME was found in 8 (13.6%) vertebral corner vs. 9 (18.8%), in 2 (3.4%) facet joints vs. 7 (14.6%) and in 1 (1.7%) spinous processes vs. 9 (18.8%) in patients with RA/r-axSpA. In contrast, more patients with RA (30.5% vs6.3%) showed erosive osteochondrosis with endplate BME (p = 0.002)., Conclusion: While involvement of upper cervical inflammation was typically present in RA, r-axSpA patients showed more BME in lower CS segments, vertebral corners, facet joints and spinous processes. Neck pain is linked to upper and lower inflammatory and structural lesions of the CS in both diseases., (© 2024. The Author(s).)

Objective: Patients with axial spondyloarthritis (axSpA) suffer from clinical symptoms like morning stiffness and back pain. Mobility of patients with axSpA is often impaired. The aim of this study is to compare the performance of patients with axSpA regarding mobility measures including performance-based tests and objective electronic assessments with the Epionics SPINE device (ES) at different times of the day compared with healthy controls (HC)., Methods: Observational trial, consecutive inpatients with axSpA (n=100) and 20 HCs were examined in the morning (V1: before 10:00 am) and in the afternoon (V2: after 02:00 pm) by the Bath Ankylosing Spondylitis Metrology Index (BASMI), the AS physical performance index (ASPI), the Short Physical Performance Battery (SPPB) and ES measurements, including range of motion (RoM) and range of kinematics (RoK)., Results: The assessments of patients with axSpA performed in the morning clearly differed from those in the afternoon, especially regarding performance-based tests. Significant improvements were seen for BASMI (4.0±3.8 to 3.8±1.9; p<0.001), ASPI (36.2±18.3 to 28.8±11.9 s; p<0.001), SPPB (10.1±1.5 to 10.7±1.4 points; p<0.001) and for ES measures of speed (RoK; p<0.018) but not for RoM, except for lateral flexion (13.3±7.4 to 14.7±8.2°; p=0.002). This time of assessment-related variability was not observed in HC., Conclusion: The spinal mobility of patients with axSpA was worse in the morning but significantly improved in the afternoon. This was captured best by performance-based measures and was not seen in HC. The diurnal variation of mobility has implications for clinical studies, suggesting that the time of assessments needs to be standardised., Competing Interests: Competing interests: The authors declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: Dr DK has received grant and research support and consultancy fees from AbbVie, BMS, Boehringer Ingelheim, Chugai, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche and UCB. Dr JB has received honoraria for talks, advisory boards, paid consultancies and rants for studies from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi Aventis and UCB. Dr UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB. NK, LS and ST: none. Dr IA has received research support, consultancy fees and honoraria from Abbvie, Amgen, BMS, Chugai, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sobi, Takkeda and UCB. Dr BB has received honoraria for talks, advisory boards, paid consultancies and/or travel support from Abbvie, Alexion, Amgen, Biogen, Boehringer Ingelheim, Gilead/Galapagos, Janssen, MSD, Theramex, Sanofi-Genzyme and UCB. Dr PS has received grant and research support and consultancy fees from AXIOM Health, AMGEN, AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Chugai Pharma Marketing/Chugai Europe, Deutscher Psoriasis-Bund, Gilead Sciences, Hexal Pharma, Janssen-Cilag, Johnson & Johnson, Lilly/Lilly Europe/Lilly Global, medi-login, Mediri GmbH, Novartis Pharma, Onkowissen GmbH, Pfizer, Roche Pharma, Rheumazentrum Rhein-Ruhr, Sanofi-Genzyme, Spirit Medical Communication, Swedish Orphan Biovitrum, UCB Pharma. SH has received consultancy fees of AbbVie and Novartis. Dr XB has received grant and research support and consultancy fees from AbbVie, Amgen, Chugai, Galapagos, Hexal, Lilly, MSD, Novartis, Pfizer and UCB., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The treatment of patients with axial spondyloarthritis (axSpA) is characterized by non-pharmacological and pharmacological treatment options. It may depend on the type and extent of musculoskeletal and extramusculoskeletal manifestations. Recent data on non-pharmacological treatment options, such as physical activity, physiotherapy, and modification of lifestyle factors, are summarized in this review. Moreover, we have provided an overview on non-steroidal anti-inflammatory drugs and the ever-expanding number of biological and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs, respectively). In addition to data on efficacy and safety, the review also encompasses data on switching/cycling, tapering, and treatment selection for specific patient subgroups to optimize treatment outcomes., Competing Interests: Conflict of interest Dr. Baraliakos: Research Support: Abbvie, Novartis, and MSD; Consultant, Speakers Bureau, Scientific Advisory Board and Honoraria: Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB. Dr. Kiltz has received a grant, research support, and consultancy fees from AbbVie, Amgen, Biocad, Biogen, BMS, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche, UCB, and Viatris. Dr. Ciurea received honoraria for educational lectures from Abbvie and Novartis. Iuliia Kononenko declares no conflicts of interest or funding., (Copyright © 2023. Published by Elsevier Ltd.)

Introduction: The course of axial spondyloarthritis (axSpA) is often characterized by impairments in physical function and mobility. Regular physical activity (PA) is a cornerstone of axSpA management. Recent European League Against Rheumatism (EULAR) recommendations for PA have stressed the importance of their implementation., Objective: Cohort study to investigate the awareness on and individual implementation of axSpA patients towards PA., Methods: Patients with axSpA and impaired physical function (Bath AS Functional Index [BASFI] score≥2.0) were recruited consecutively. All patients underwent a clinical examination including assessments of disease activity, physical function, mobility and global functioning. Patients also had to fill out structured questionnaires on knowledge, awareness and individual attitudes to PA., Results: Out of a total of 100 patients enrolled, 96 were included. Most respondents (n=82, 85.4%) were aware that PA has significant health benefits for patients with axSpA. Even though less than half of the patients (n=44, 42.7%) were aware that actual EULAR recommendations do exist, 45 patients (46.9%) did already fulfill these in terms of frequency/week. The majority of patients (n=61, 67.7%) had been informed about the benefits of PA by their physician, and physiotherapy had often been prescribed (n=61, 63.3%). Many patients (n=51, 53.1%) reported to perform individual exercise programs, and some (n=22, 22.9) supervised PA., Conclusion: Even though the majority of axSpA patients are not aware of the recent EULAR recommendations for PA, many understand and agree that PA is beneficial for their health status. Health care providers should concentrate on the patients who are not active and do not know about the benefits of PA., (Copyright © 2023 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

A standardized documentation of the clinical manifestation and patient-reported outcome (PRO) of patients with axial spondylarthritis (axSpA) is necessary in order to assess the disease with respect to disease activity and severity and to achieve the foundations for clinical decisions. The standardized documentation refers to domains such as disease activity, quality of life, functional capacity and ability to work but also to individual aspects, such as pain, arthritis and enthesitis. The domains as well as the individual aspects are mainly collected directly from PROs using a self-report questionnaire. An exception is the clinical examination of the inflammatory involvement of joints, entheses and the physical examination of spinal mobility. In interventional studies, status or response criteria are used to quantify changes. The lack of objective clinical criteria for documentation of inflammatory activity poses a particular challenge in axSpA, therefore, the PROs need to be interpreted critically taking objective disease parameters into consideration. Most instruments were developed in the 1990s in Bath, UK and in the last 15 years by the Assessments in Axial Spondylarthritis International Society (ASAS) for use in studies., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Objectives: To compare the influence of age on inflammatory (bone marrow oedema [BME]) and structural (fat lesions [FL], erosions and ankylosis) MRI lesions in the sacroiliac joints (SIJ) of patients with and without axial spondyloarthritis (axSpA)., Methods: In a retrospective study, SIJ MRI (STIR/T1 sequences) of consecutive patients with chronic back pain diagnosed with axSpA or non-SpA were evaluated based on SIJ quadrants (SIJ-Q). Two blinded readers evaluated BME and structural lesions. Reader agreement was evaluated for prevalence of MRI lesions related to age., Results: MRIs of 309 (175 axSpA, 134 non-SpA) patients were evaluated. Their mean age was 38.5 (11.4) and 43.4 (13.8) years, 67% and 36% were male, CRP was 1.6 (2.4) and 1.1 (2.1) mg/dl and median symptom duration was 48 and 60 months for axSpA and non-SpA, respectively. SIJ-Q with BME and erosions were significantly more frequent in axSpA vs non-SpA patients independent of age, while this difference was seen for FL only in patients ≥50 years. The proportion of patients with ≥1 or ≥3 BME or chronic lesions except for FL increased with age in both groups, and was constantly higher in axSpA vs non-SpA. In univariate analyses, only female sex was significantly associated with more FL., Conclusions: The proportion of patients with MRI lesions was high in both axSpA and non-SpA patients. However, the prevalence of BME and erosions was significantly more frequent in patients with axSpA, was independent of age and also allowed for discrimination. FL occurred more frequently only in older age groups and were less reliable for discrimination vs non-SpA patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Quality standards (QS) are measurable constructs designed to quantify gaps in care and subsequently to improve quality of care. The Assessment of SpondyloArthritis International Society (ASAS) recently generated and published international QS for the management of patients with axial spondyloarthritis (axSpA) for the first time. The German Society of Rheumatology (DGRh) then decided to translate, review and possibly adopt these standards by a group of experts from different care settings. Against this background, national QS for the management of patients with axSpA for Germany were developed for the first time. The main focus was on feasibility and practical relevance. Ultimately, nine QS were defined with which the quality of care in Germany can and should be measured and improved., (© 2021. The Author(s).)

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic condition, historically considered a predominantly male disease. However, increasing evidence suggests a more equal prevalence between men and women. Of the limited research conducted to date, it is apparent that gender differences exist in terms of time to diagnosis, treatment outcomes and health-related quality of life (HRQoL). Despite this, women are underrepresented in clinical trials and most studies do not stratify by gender to identify potential differences in terms of disease manifestations and treatment response. In this perspectives article, we reflect on the potential biological and social factors contributing to these differences and propose three key areas of education and research that should be prioritised in order to address the unmet needs of female patients with axSpA, namely: (1) to identify ways to increase awareness of disease occurrence in female patients among healthcare professionals (HCPs), (2) to improve understanding of gender differences in disease manifestation and outcomes, and (3) to conduct gender-stratified clinical trials with a representative sample of female patients., (© 2022. The Author(s).)

Although the pathogenesis of spondyloarthritis (SpA) has still not been elucidated our options to treat SpA have definitely improved in the last decades. There are two main types of SpA: (i) axial spondyloarthritis (axSpA), also covering the classical ankylosing spondylitis (AS) which is largely equivalent to radiographic (r)-axSpA but different from non-radiographic (nr)-axSpA, and (ii) peripheral SpA (pSpA) also covering psoriatic arthritis (PsA) as the main subtype. The subtype nr-axSpA has historically developed because the approval of drugs for AS did not cover forms without structural changes in the sacroiliac joints which is mandatory in the 1984 New York criteria. The definitions for axSpA are based on the 2009 Assessments in AxSpA International Society (ASAS) classification criteria. Several biologic disease modifying anti-rheumatic drugs (bDMARDs) such as the tumor necrosis factor alpha inhibitors (TNFi) and the interleukin-17-inhibitors (IL-17i) are approved mostly for the whole spectrum of SpA including axSpA and PsA but L-17i does not work in inflammatory bowel disease (IBD). Targeted synthetic (ts) DMARDs cover mainly the janus kinase (JAK)-inhibitors which have recently been developed to inhibit inflammation in several rheumatic and other immune mediated diseases such as IBD. Indeed, the physiologic mechanism of JAK-mediated signal transduction has been recognized as an important target because the inhibition of its actions was shown to successfully work as a therapeutic mechanism. There are now 4 small molecule JAK inhibitors (JAKi) that currently play a role in rheumatology with variable selectivity for the four different JAK isoforms: tofacitinib, baricitinib, upadacitinib and filgotinib. In this review, we summarize current clinical trial data and evaluate the use of the JAK1 selective inhibitor upadacitinib in the treatment of axSpA, including nr-axSpA and r-axSpA. Even though the efficacy and safety of upadacitinib over shorter periods of time has been convincing to date, long-term trials are needed to fully establish its performance and also evaluate the safety at higher doses, and its use in PsA., Competing Interests: Prof. Dr. Jürgen Braun, PD Dr.Uta Kiltz and Prof.Dr.X.Baraliakos did not receive any grants for the conduct of this manuscript. Professor Jürgen Braun reports grants, personal fees from Abbvie, Lilly, Galapagos, but not during the conduct of the study; and grants, personal fees from Novartis, outside the submitted work. Dr Uta Kiltz reports personal fees and/or grants from Abbvie, Amgen, Lilly, Fresenius, Gilead, GSK, Hexal, Janssen, MSD, Novartis, Pfizer, and UCB, outside the submitted work. The authors report no other conflicts of interest in this work, and they confirm that there was no third party influence on the content of this review., (© 2022 Braun et al.)

Background: The ASAS Health Index (ASAS HI) was developed to assess global functioning in patients with axial spondyloarthritis (axSpA). Influencing factors have not been studied to date, especially the influence of inflammation and structural changes in the spine has remained unclear to date., Objective: To find out whether and to what degree do axial inflammation, radiographic damage and other clinical features influence global functioning of patients with axSpA., Methods: Patient reported outcomes (ASAS HI, pain, BASDAI, BASFI, EQ-5D and SF-36) were assessed, spinal mobility by BASMI and depression by SF-36 scores. Axial inflammation was quantified using the MRI Berlin score and structural damage as detected by conventional radiographs by the modified Stokes AS Spinal Score (mSASSS). Correlation and regression analyses were performed to analyze the association between global functioning and other variables., Results: A total of 191 axSpA patients with different degrees of global functioning and disease activity was included, 60.2% had r-axSpA. Syndesmophytes were found in 38.5% of patients - with a median mSASSS score of 3.8 (IQR 1.0-18.7) in r-axSpA and 0.0 (IQR 0.0-1.2) in nr-axSpA patients. The mean MRI score was 2.3 (IQR 0.5-7.6). ASAS HI values correlated significantly with BASMI, BASDAI, BASFI, BMI and MRI scores. However, no significant correlation was found for mSASSS and CRP. Regression analyses revealed that global functioning was significantly influenced by disease activity, physical function, obesity and depression but not by structural damage or spinal inflammation as detected MRI., Conclusions: Our study shows that global functioning is strongly associated with physical function, body weight and depression in patients with axSpA but not with spinal inflammation and structural damage. This may be explained by the relatively low mSASSS of these well treated patients., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To investigate the performance of a health app with respect to usability, adherence, and equivalence of data in daily care of patients with axial spondyloarthritis (axSpA)., Methods: Consecutive patients with axSpA were asked to export patient-reported outcomes (PRO) electronically with the AxSpA Live App regularly every 2 weeks over a period of 6 months. The first clinical visit was followed by 2 further personal visits after 3 and 6 months. Patients completed paper-based PRO at every visit; they also completed the Mobile App Rating Scale and the System Usability Scale after 3 and 6 months., Results: Of 103 patients with axSpA, 69 agreed to participate (67.0%): age 41.5 (11.3) years, 58.0% male, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 4.3 (2.0), and 76.8% treated with biologic disease-modifying antirheumatic drugs. Patients' adherence to regular app exports was 29.0% and 28.4% after 3 and 6 months, respectively. Significant predictors for good adherence were high disease activity ( P = 0.02) and older age ( P = 0.04). No systematic differences between digital and paper-based BASDAI scores were found (intraclass correlation coefficients 0.99 [95% CI 0.98-0.99]). Performance of the app was rated as good., Conclusion: Collection of digital PROs by AxSpA Live App may be successfully used in patients with axSpA with high disease activity. Our study showed equivalence of digital data, but adherence to the app after 6 months was poor. Higher disease activity and older age resulted in increased adherence to the app. This suggests that the use of health apps like this should concentrate on more severely affected patients., (Copyright © 2022 by the Journal of Rheumatology.)

Objectives: To study the efficacy and safety of ixekizumab (IXE) in patients with radiographic (r-) and non-radiographic (nr-)axial spondyloarthritis (axSpA) for up to 116 weeks., Methods: COAST-Y (NCT03129100) is the 2-year extension study following COAST-V, COAST-W and COAST-X. Patients were treated with either 80 mg IXE every 4 weeks or 2 weeks, as assigned in the originating studies. Efficacy was assessed in all participants continuously treated with IXE through week 116 and in subgroups based on disease subtype and dosing. Missing data were handled by non-responder imputation for categorical variables and modified baseline observation carried forward for continuous variables. Safety data were analysed in all patients having received ≥1 IXE dose., Results: Of 932 patients who received ≥1 IXE dose, 773 enrolled in COAST-Y (82.9%); 665 of which (86.0%) completed week 116. Of 352 continuously treated patients, the proportion achieving Assessment of Spondyloarthritis International Society (ASAS40) at week 52 was 51.4%, which increased to 56.0% at week 116. The proportion of patients achieving ASAS40 at week 116 was 64.9% and 57.7% for biological disease-modifying antirheumatic drug (bDMARD)-naïve patients with r-axSpA and nr-axSpA, respectively, and 47.0% for TNFi-experienced patients. The proportion of patients achieving Ankylosing Spondylitis Disease Activity Score <2.1 through week 116 was 57.0% and 52.9% for bDMARD-naïve patients with r-axSpA and nr-axSpA, respectively, and 33.6% for TNFi-experienced patients. Incidences of treatment-emergent adverse events and serious adverse events were consistent with previous reports., Conclusion: IXE treatment led to sustained long-term improvements in patients with axSpA, with similar efficacy for r-axSpA and nr-axSpA, and for patients receiving the approved every 4 weeks dose. The safety profile of IXE was consistent with previous reports. No new safety signals were identified., Competing Interests: Competing interests: JB has received compensation as a speaker, adviser, or consultant for, or has received grant support from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Fresenius, GlaxoSmithKline, Gilead, Hexal, Janssen, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB. MD has received compensation as a consultant or adviser for, and has received grant support from Abbvie, Biogen, Eli Lilly and Company, Galapagos, Merck, Pfizer and UCB. UK has received compensation as a consultant, adviser, or speaker for Abbvie, Eli Lilly and Company, Hexal, Janssen, MSD, Novartis, Pfizer, UCB and Viatris; and has received grant support from Amgen, Hexal and Novartis. AD has received compensation as a consultant, adviser or speaker for Abbvie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, GlaxoSmithKilne, Janssen, Novartis, Pfizer and UCB; has received travel, grant, or research support from Abbvie, Eli Lilly and Company, GlaxoSmithKline, Novartis, Pfizer and UCB; and serves as a member of the GRAPPA steering committee. TT has received compensation as a consultant and adviser for Eli Lilly and Company; and as a speaker for Abbvie, Bristol Myers Squibb, Eli Lilly and Company, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer. JW has received compensation as a consultant for Abbvie, Amgen, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB; has received grant or travel support from Abbvie, Eli Lilly and Company, Merck, and Pfizer. DS, and CL are full-time employees and shareholders of Eli Lilly and Company. RB is an employee and shareholder of Eli Lilly and Company; has received travel support for and has received compensation as an adviser for Eli Lilly and Company., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI)., Method: First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion. Third, the final English EFIS was translated into 15 languages and cross-culturally validated., Results: The initial item pool contained 53 EF addressing four ICF EF chapters: products and technology (e1), support and relationship (e3), attitudes (e4) and health services (e5). Based on 1754 responses of axial spondyloarthritis patients in an international survey, 44 of 53 initial items were removed based on low correlations to the ASAS HI or redundancy combined with expert opinion. Nine items of the initial item pool (range correlation 0.21-0.49) form the final EFIS. The EFIS was translated into 15 languages and field tested in 24 countries., Conclusions: An EFIS is available complementing the ASAS HI and helps to interpret the ASAS HI results by gaining an understanding of the interaction between a health condition and contextual factors. The EFIS emphasizes the importance of support and relationships, as well as attitudes of the patient and health services in relation to self-reported health., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

This review article presents the innovations in the update of the S3 guidelines on axial spondylarthritis. The total of eight new recommendations address the areas of the consideration of differential diagnoses, coordination of comorbidity management, including a vaccination strategy, treatment targets, safety of nonsteroidal anti-inflammatory drugs (NSAID), treatment response to biological disease-modifying antirheumatic drugs (bDMARD) and discontinuation strategies when remission has been achieved. In this article the authors deal particularly with the areas of early diagnosis and referral as well as exercise therapy and drug treatment., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Objectives: To assess the effectiveness of secukinumab in patients with axSpA treated in routine clinical settings in 5 European countries., Methods: Retrospective analysis of a cross-sectional survey to assess real-world effectiveness of secukinumab in the management of axSpA and rheumatologist satisfaction with treatment in France, Germany, Italy, Spain and the UK from March to December 2018. Outcomes collected included patient demographics, clinical characteristics and rheumatologist- and patient-reported satisfaction with secukinumab treatment., Results: Five hundred thirty-five patients receiving secukinumab for more than 4 months were assessed, 359 of whom were diagnosed with AS and 178 with nr-axSpA. Rheumatologist assessment of disease status at treatment initiation indicated that 39 (7.3%) had stable/improving disease. Secukinumab treatment for 4 months or longer resulted in 515 (95.9%) patients judged as stable/improving. Treatment was associated with benefits from initiation to assessment in terms of BASDAI (6.2 vs 2.8), 44-joint count score (9.7 vs 6.6), rheumatologist global VAS score (56.9 vs 23.0) and patient global VAS scores (64.4 vs 25.5). These benefits for key clinical outcomes were sustained for periods of 12 months or longer. Patient-reported outcomes on health status using EQ-5D, global functioning using the ASAS health index and overall work impairment via WPAI were sustained over the treatment period, while patient and rheumatologist satisfaction with secukinumab treatment remained very high at 80.2 and 91.2%, respectively., Conclusion: Consistent benefits across multiple clinical and patient-reported outcomes were seen with secukinumab treatment in patients with AS and nr-axSpA treated in routine clinical settings across five European countries. Key Points • In routine clinical settings across five European countries, secukinumab treatment resulted in improvements in a wide range of clinical outcomes including physician-reported disease severity, disease status, pain, BASDAI, 44-joint count score and global VAS scores. • Key clinical and patient reported outcomes were sustained for a 12-month period or longer with secukinumab treatment. • Rheumatologist- and patient-reported treatment satisfaction was high with secukinumab., (© 2021. International League of Associations for Rheumatology (ILAR).)

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to reduce pain and inflammation, and are considered the cornerstone of pharmacological intervention in patients with radiographic axial spondyloarthritis (r-axSpA); however, the long-term use of NSAIDs is debatable due to their restricted therapeutic potential and the risk of side effects and complications. Therefore, reduction in NSAID intake is desirable in r-axSpA patients. Here, we report the long-term NSAID-sparing effect of secukinumab over 4 years in patients with r-axSpA. This post hoc analysis pooled data from 3 secukinumab trials (MEASURE 2-4) for each secukinumab maintenance dose of 150 and 300 mg, regardless of the loading dose regimen being i.v. or s.c. NSAID intake was evaluated prospectively using the Assessment of SpondyloArthritis International Society (ASAS)-NSAID score. Patients with an ASAS-NSAID score > 0 at baseline were analysed. NSAID-sparing endpoints included the mean change in the ASAS-NSAID score, the proportion of patients achieving 50% reduction, and the proportion of patients with an ASAS-NSAID score < 10. Percentages of patients who achieved BASDAI ≤ 2 were also assessed. Overall, 562 patients were included in this pooled analysis (secukinumab: 150 mg, N = 467; 300 mg, N = 95). The mean ASAS-NSAID score decreased with time in both the secukinumab 150 mg and 300 mg dose groups. The proportion of patients who achieved 50% reduction in the ASAS-NSAID score and clinically meaningful reduction of ASAS-NSAID score < 10 increased with time in both dose groups and in both low and high NSAID intake patients. The percentage of patients with a clinically relevant improvement (BASDAI ≤ 2) was consistently higher in patients with an ASAS-NSAID score < 10 than in patients with an ASAS-NSAID score ≥ 10. Secukinumab provided sustained, long-term NSAID-sparing effects in patients with r-axSpA for up to 4 years of treatment, as measured using the ASAS-NSAID score. Trial registered at clinicaltrials.gov: NCT01649375 ( https://clinicaltrials.gov/ct2/show/NCT01649375 ); NCT02008916 ( https://clinicaltrials.gov/ct2/show/NCT02008916 ); NCT02159053 ( https://clinicaltrials.gov/ct2/show/NCT02159053 )., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease that manifests primarily in the axial skeleton, initially mostly in the sacroiliac joints (SIJ), usually later spreading to the spine. The disease is characterised by inflammation and new bone formation which are mainly assessed by conventional radiography (CR) and magnetic resonance imaging (MRI). Tumour necrosis factor inhibitors (TNFi) and interleukin-17 antagonists have been shown to be efficacious and efficient in patients with axSpA. This treatment seems to also inhibit structural damage, for example, retard radiographic progression. Indeed, a reduction of new bone formation in the spine, as assessed by CR, has been reported to occur after at least 2 years of therapy with TNFi. Recently, a reduction of erosions and ankylosis in the SIJ has also been observed in axSpA patients treated with etanercept and filgotinib. In this narrative review, we discuss the limited significance of such findings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary., Objective: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA)., Methods: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies., Results: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials., Conclusion: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain., Competing Interests: Declaration of Competing Interest V. Navarro-Compán: Research grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer, and UCB. A. Boel has no competing interests to declare. A. Boonen: Research grants from AbbVie and Novartis and honoraria for boards or lectures form AbbVie, Galapagos and Lilly. R. Landewé: Honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Eli-Lilly, Novartis, Pfizer, UCB Pharma. Director of Rheumatology Consultancy BV. U. Kiltz: Grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. M. Dougados: Consulting fees from Pfizer, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB Pharma. W. Bautista-Molano: Research speaker´s fees from Janssen, Lilly, Novartis, Pfizer, and Biopas. X. Baraliakos: Consulting fees from AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB. P. Chiowchanwisawakit: Research grants/honoraria from Novartis, Pfizer, Zuellig Pharma, Janssen. N. de Peyrecave: Employee of UCB Pharma. B. Elzorkany: Consultancy, research grants, and speaker's fees from: AbbVie, Amgen, BMS, Eva, Hekma, Janssen, Lilly, MSD, New Bridge, Novartis, Pfizer, Roche, Sanofi‐Aventis, and Servier. L. Fallon: Employee and shareholder of Pfizer Inc. K. Gaffney: Research grants from AbbVie, Lilly, Novartis, Pfizer, UCB. Consulting fees: AbbVie, Celltrion, Celgene, Gilead, Lilly, MSD, Novartis, Pfizer, UCB: Director Spondyloarthritis Academy (SPATE UK). LS. Gensler: Research grants/honoraria from AbbVie, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB. N. Haroon: Consultant for Amgen, Abbvie, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB. PM. Machado: Consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript. WP. Maksymowych: Consulting fees from Abbvie, BMS, Boehringer, Celgene, Lilly, Janssen, Novartis, Pfizer, UCB; Research and/or Educational Grants Abbvie, Novartis, Pfizer; Chief Medical Officer CARE Arthritis Limited. S. Ramiro: Research grants from Galapagos, MSD, Novartis, Pfizer and consulting fees from AbbVie, Eli Lilly, MSD, Novartis, UCB and Sanofi. D. Poddubnyy: Research support from AbbVie, Lilly, MSD, Novartis, and Pfizer. Consulting fees from: AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB. Speaker fees from: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, and UCB. I-H. Song: Employee of AbbVie, Immunology Clinical Development, USA. D. van der Heijde: Consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma. Director of Imaging Rheumatology bv., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Advances in the field of axial spondyloarthritis (axSpA) and the methodology to develop core sets have led the Assessment of SpondyloArthritis international Society (ASAS) group to update the ASAS-Outcomes in Rheumatology (OMERACT) core set. An important aspect was to ensure it would be applicable to the entire spectrum of axSpA. The first step was to define the most relevant disease domains., Methods: A 3-round Delphi survey was conducted to gather opinions of 188 patients and 188 axSpA experts to define the most relevant disease domains to be included in the core set. The Delphi survey evaluated 2 separate research settings: (1) studies assessing symptom-modifying therapies; and (2) studies evaluating disease-modifying therapies. Importance of the domains was rated on a 1-9 Likert scale. A domain was considered for inclusion if, for both stakeholder groups, ≥ 70% of participants scored the domain as critical (7-9) and ≤ 15% scored it as not important (1-3) after 3 rounds., Results: A total of 132 (70%) patients and 135 (72%) experts completed at least 1 round. After 3 rounds, 7 domains (pain, physical function, stiffness, disease activity, mobility, overall functioning and health, peripheral manifestations) were selected for the symptom-modifying therapies setting. For the disease-modifying therapies setting, 6 domains (physical function, disease activity, mobility, structural damage, extramusculoskeletal manifestations, peripheral manifestations) were selected. All domains selected by experts were also selected by patients. Patients selected all offered domains except emotional function., Conclusion: This study provides the domains selected by patients and axSpA experts that should be considered for the core set for axSpA., (Copyright © 2021 by the Journal of Rheumatology.)

Emerging evidence suggests that axial spondyloarthritis (axSpA) should not be seen as a predominantly male disease, as the non-radiographic form occurs with roughly equal frequency in women and men. However, men and women experience this disease differently. The purpose of this review is to highlight sex-associated and gender-associated differences in the patient's journey through the diagnosis and management of axSpA, in order to increase the awareness about the unmet needs of female axSpA patients.Female patients experience a longer diagnostic delay compared with men, possibly due to the different pattern of clinical presentations across genders. Therefore, it is crucial to sensitise physicians to pay attention and identify the red flags of axSpA in women and promote early referral to a rheumatologist. Women with a diagnosis of axSpA experience greater limitations in physical function, although they have less structural spinal damage compared with men. Women tend to have less adherence and a lower response to treatment, so more gender-oriented data are needed about drugs used for axSpA, especially biological disease-modifying antirheumatic drugs.Lifestyle factors have a strong impact on the disease course. Interventions regarding physical activity, smoking cessation and diet should be communicated to the patients, with particular attention to the gender-related cultural background.Patients of childbearing age living with axSpA should be engaged in a discussion about reproductive health, in terms of preservation of fertility, management of pregnancy and delivery and use of biologic drugs during pregnancy and breastfeeding., Competing Interests: Competing interests: MSC received speaking fees and honoraria from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer, UCB. RA has received speaking fees and honoraria from Abbvie, BMS, Galapagos, Eli Lilly, Janssen, Novartis, Pfizer, Viatris. MAD'A received speaking fees and honoraria from Abbvie, BMS, Eli Lilly, Janssen, Novartis, Pfizer, UCB. EG received speaking fees and honoraria from Abbvie, BMS, Eli Lilly, GSK, Janssen, Novartis, Pfizer, Sanofi. UK received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Janssen, MSD, Novartis, Pfizer, Roche, UCB and Viatris. EL has no disclosures. MMM-L received speaking fees and honoraria from Abbvie, Janssen, Novartis, UCB, Amgen, Pfizer. TP received speaking fees and honoraria from Abbvie, Amgen, Biogen, BMS, Celgene, Celltrion, Fresenius-Kabi, Galapagos, Gilead, Janssen, Lilly, MSD, Nordic, Novartis, Pfizer, Roche-Chugai, Sandoz, Sanofi, UCB. RR received speaking fees and honoraria from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, MSD. FRS received speaker fees and consultancies from Eli Lilly, Gilead, Galapagos, Glaxo Smith Kline, Novartis and Sanofi. CP is an employee of Novartis. LA received speaking fees and honoraria from Glaxo Smith Kline, Eli Lilly, Janssen, Novartis, UCB., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: There is a lack of outcome measures to assess the impact of axial spondyloarthritis (axSpA) on health, function and quality of life. The Assessment of SpondyloArthritis International Society (ASAS) group developed the ASAS Health Index (ASAS-HI) and the ASAS Environmental Factors Item Set (ASAS-EF) to measure functioning and health across all aspects of health that are typically affected and relevant for patients with axSpA, based on the International Classification of Functioning, Disability and Health (ICF). The aim of this paper was to describe the translation and cross-cultural adaptation of both questionnaires into European Portuguese among patients with radiographic and non-radiographic axial SpA (nr-axSpA) and test the conceptual equivalence of the translated version in the Portuguese context. Material and Methods: The ASAS-HI and ASAS-EF were firstly translated into European Portuguese and then back-translated into English, following forward-backward procedure. After the review of the Portuguese version by an expert committee, the field test with cognitive debriefing involved a sample of 10 axSpA patients with different gender, age, disease duration, and educational background. Results: Minor difficulties arose from the translation process of the ASAS-HI. The EF Item Set offered more difficulties indicating that concepts underlying the contextual factors may be more culture-dependent. A total of 10 patients with axSpA [8 males, mean age of 41.4 (±13.7)] participated in the field test. Cognitive debriefing showed that items of the ASAS-HI and EF Item Set of the Portuguese version are clear, relevant, understandable and easy to complete. As a result of cognitive debriefing, the wording of four items had to be changed to avoid misunderstandings or unintended interpretations, and a new response option "not applicable" was added to two items of the ASAS-HI to improve appropriateness. Conclusions: The resulting Portuguese version of the ASAS-HI and ASAS-EF showed acceptable linguistic validity and has potential for use in both clinical practice and research settings. Nevertheless, before European Portuguese versions can be fully implemented, its psychometric properties (validity and reliability) need to be evaluated. [ABSTRACT FROM AUTHOR]