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Ankylosing spondylitis (AS) is the historic term used for decades for the HLA-B27-associated inflammatory disease affecting mainly the sacroiliac joints (SIJ) and spine. Classification criteria for AS have radiographic sacroiliitis as a dominant characteristic. However, with the availability of MRI of SIJ, it could be demonstrated that the disease starts long before definite SIJ changes become visible on radiographs. The Assessment of SpondyloArthritis international Society, representing a worldwide group of experts reached consensus on changes in the nomenclature pertaining to axial spondyloarthritis (axSpA), such as the terminology of diagnosis and of assessment of disease activity tools. These are important changes in the field, as experts in axSpA are now in agreement that the term axSpA is the overall term for the disease. A further differentiation, of which radiographic versus non-radiographic is only one aspect, may be relevant for research purposes. Another important decision was that the terms AS and radiographic axSpA (r-axSpA) can be used interchangeably, but that the preferred term is r-axSpA. Based on the decision that axSpA is the correct terminology, a proposal was made to officially change the meaning of the ASDAS acronym to 'Axial Spondyloarthritis Disease Activity Score'. In addition, for simplification it was proposed that the term ASDAS (instead of ASDAS-CRP) should be preferred and applied to the ASDAS calculated with C reactive protein (CRP). It is hoped that these changes will be used consequently for education, in textbooks, manuscripts and presentations., Competing Interests: Competing interests: DvdH has received consulting fees from AbbVie, Argenx, Bayer, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB Pharma. She is Director of Imaging Rheumatology bv, associate editor of ARD, editorial board member of J Rheumatol and RMD Open, advisor of ASAS. AM has received consulting fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma and Viatris. SR has received research grants and/or consulting fees from AbbVie, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB, Sanofi. MD has received consulting fees from Pfizer, AbbVie, UCB, Amgen, BMS, Galapagos, Lilly, Novartis, Merck. FAvG has received consultation fees from Novartis, BMS, AbbVie, MSD, Janssen, Lily, UCB. LG has received research grants and/or consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, UCB. RDI has received consulting fees from Abbvie, Janssen, Novartis, UCB. RBML has received consulting fees from AbbVie, BMS, Galapagos, Eli-Lilly, Novartis, Jansen, Pfizer and UCB, is director of Rheumatology Consultancy BV and past-president and executive member of ASAS. HM-O has received grant support from Janssen, Novartis and UCB. Honoraria and/or speaker fees from AbbVie, Biogen, Eli-Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB. VN-C has received consultancy/speaker/research grants from Abbvie, BMS, Fresenius Kabi, Galapagos, Janssen, Lilly, Moonlake, MSD, Novartis, Pfizer, Roche, UCB. AP, Patient with AxSpa, Eupati Fellow, Patient Expert, Advocator, President of Cyprus League of People with Rheumatism, President of AGORA Federation, Secretary of Axial Spondylarthritis International Federation (ASIF), EULAR-Advocacy Committee Member-Pare Committee Member. DP has received research support from AbbVie, Eli Lilly, MSD, Novartis, Pfizer, consulting fees from AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer and UCB, and speaker fees from AbbVie, Canon, DKSH, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer and UCB. MP has received consulting fees from Novartis as well as support for attending meetings and/or travel from Abbvie, Jannsen, Novartis and UCB. MR has receieved consulting/speaker fees from Abbvie, Chugai, Boehringer, Eli-Lilly, Janssen, Novartis, UCB. PDS-B has received consulting/ speaker's fees from AbbVie, Celltrion, Eli Lilly, GSK, Janssen, Novartis, Pfizer and UCB. AS has received speaking and/or consulting fees from Abbvie, Novartis, UCB and Lilly. JS has received gees for consultancies and for being a member of speakers’ bureau from Abbvie, Merck, Novartis and UCB. FEVdB has received consulting fees from Abbvie, Amgen, Eli Lilly, Galapagos, Janssen, Moonlake, Novartis and UCB. IvdH-B has received consulting/speaker’s fees from UCB, Lilly, AbbVie, MSD, BMS, Novartis. PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB. XB has received consulting/speaker’s fees Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Zuellig Pharma and is Member of the Editorial Board of ARD, ASAS President and EULAR President Elect., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)

Objectives: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated superior efficacy versus placebo in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) at Week 16. Here, the objective is to report the efficacy and safety of BKZ at Week 52., Methods: BE MOBILE 1 (nr-axSpA; NCT03928704) and BE MOBILE 2 (r-axSpA; NCT03928743) comprised a 16-week, double-blind, placebo-controlled period, then a 36-week maintenance period. From Week 16, all patients received subcutaneous BKZ 160 mg every 4 weeks., Results: Improvements versus placebo in Assessment of SpondyloArthritis International Society ≥40% response (primary endpoint), Ankylosing Spondylitis Disease Activity Score, high-sensitivity C-reactive protein levels and MRI inflammation of the sacroiliac joints/spine at Week 16 were sustained to Week 52 in BKZ-randomised patients. At Week 52, responses of patients switching from placebo to BKZ at Week 16 were comparable to BKZ-randomised patients. At Week 52, ≥1 treatment-emergent adverse events (TEAEs) were reported in 183 (75.0%) and 249 (75.5%) patients with nr-axSpA and r-axSpA, respectively. Serious TEAEs occurred in 9 (3.7%) patients with nr-axSpA and 20 (6.1%) patients with r-axSpA. Oral candidiasis was the most frequent fungal infection (nr-axSpA: 18 (7.4%); r-axSpA: 20 (6.1%)). Uveitis occurred in three (1.2%) and seven (2.1%) patients with nr-axSpA and r-axSpA, and inflammatory bowel disease in two (0.8%) and three (0.9%)., Conclusions: At Week 52, dual inhibition of IL-17A and IL-17F with BKZ resulted in sustained efficacy across the axSpA spectrum; the safety profile was consistent with the known safety of BKZ., Trial Registration Number: NCT03928704; NCT03928743., Competing Interests: Competing interests: XB: Speakers bureau for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; paid instructor for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from Novartis and UCB Pharma. AAD: Speakers bureau for Janssen, Novartis and Pfizer; consultant for AbbVie, Amgen, Aurinia, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma. DvdH: Consulting fees from AbbVie, Bayer, BMS, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda and UCB Pharma; director of Imaging Rheumatology BV. MM: Consultancy fees from AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, BMS and UCB Pharma. WPM: Honoraria/consulting fees from AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, Pfizer and UCB Pharma; educational grants from AbbVie, Janssen, Novartis, and Pfizer; Chief Medical Officer for CARE ARTHRITIS. TT: Consultancy fees from AbbVie, Eli Lilly, Gilead, Novartis and Pfizer; speaker fees from AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis and Pfizer. HX: Speaker for AbbVie, Janssen, Novartis, Pfizer, and UCB Pharma; consultant for AbbVie, Beigene, BioMap, IASO, Pfizer and UCB Pharma; clinical investigator for Peking-Tsinghua Center for Life Sciences. UM, CF, AME, TV, JS-S, AM: Employees of UCB Pharma. LSG: Grants from Novartis and UCB Pharma paid to institution; consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma., (© 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.)

Objective: To assess test-retest reliability, construct validity, known groups discrimination, and responsiveness of the Assessment of the SpondyloArthritis international Society Health Index (ASAS HI) to evaluate functioning, disability, and health in patients with radiographic axial spondyloarthritis (r-axSpA)., Methods: Data were generated from 2 randomized, placebo-controlled, active-controlled phase III ixekizumab studies (COAST-V, N = 341; COAST-W, N = 316). Assessments included the following: test-retest reliability (ie, intraclass correlation coefficients [ICCs] between ASAS HI scores at screening and baseline), construct validity (ie, Spearman correlation with standard r-axSpA outcome measures), known groups discrimination (ie, 1-way ANOVA comparing the ASAS HI with different disease activity categories, measured by the Ankylosing Spondylitis Disease Activity Score [ASDAS]), and responsiveness (ie, Spearman correlation between changes in the ASAS HI and changes in the Bath Ankylosing Spondylitis Functional Index [BASFI], the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], the ASDAS, and the Patient Global Assessment [PtGA] as well as ANOVA comparing changes in the ASAS HI with various responder categories)., Results: The ICC for test-retest reliability was 0.78 for COAST-V and 0.76 for COAST-W, indicating adequate agreement. Moderate-to-large correlations ( r = 0.40-0.61) were observed between the ASAS HI and the BASDAI. Statistically significant differences (all P < 0.001) between mean ASAS HI scores were observed for subgroups based on ASDAS-defined disease activity categories at baseline and week 16. Moderate-to-large correlations existed between changes in the ASAS HI and the BASFI, BASDAI, ASDAS, and PtGA from baseline to week 16. The ASAS HI differentiated statistically ( P < 0.001) between ASAS, BASDAI, and ASDAS response groups., Conclusion: The ASAS HI demonstrated reliability, construct validity, known groups discrimination, and responsiveness in adults with r-axSpA in 2 clinical trials., (Copyright © 2023 by the Journal of Rheumatology.)

Background: Radiographic progression and course of inflammation over 2 years in patients with non-radiographic axial spondyloarthritis (nr-axSpA) from the phase 3, randomized, PREVENT study are reported here., Methods: In the PREVENT study, adult patients fulfilling the Assessment of SpondyloArthritis International Society classification criteria for nr-axSpA with elevated CRP and/or MRI inflammation received secukinumab 150 mg or placebo. All patients received open-label secukinumab from week 52 onward. Sacroiliac (SI) joint and spinal radiographs were scored using the modified New York (mNY) grading (total sacroiliitis score; range, 0-8) and modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range, 0-72), respectively. SI joint bone marrow edema (BME) was assessed using the Berlin Active Inflammatory Lesions Scoring (0-24) and spinal MRI using the Berlin modification of the AS spine MRI (ASspiMRI) scoring (0-69)., Results: Overall, 78.9% (438/555) of patients completed week 104 of the study. Over 2 years, minimal changes were observed in total radiographic SI joint scores (mean [SD] change, - 0.04 [0.49] and 0.04 [0.36]) and mSASSS scores (0.04 [0.47] and 0.07 [0.36]) in the secukinumab and placebo-secukinumab groups. Most of the patients showed no structural progression (increase ≤ smallest detectable change) in SI joint score (87.7% and 85.6%) and mSASSS score (97.5% and 97.1%) in the secukinumab and placebo-secukinumab groups. Only 3.3% (n = 7) and 2.9% (n = 3) of patients in the secukinumab and placebo-secukinumab groups, respectively, who were mNY-negative at baseline were scored as mNY-positive at week 104. Overall, 1.7% and 3.4% of patients with no syndesmophytes at baseline in the secukinumab and placebo-secukinumab group, respectively, developed ≥ 1 new syndesmophyte over 2 years. Reduction in SI joint BME observed at week 16 with secukinumab (mean [SD], - 1.23 [2.81] vs - 0.37 [1.90] with placebo) was sustained through week 104 (- 1.73 [3.49]). Spinal inflammation on MRI was low at baseline (mean score, 0.82 and 1.07 in the secukinumab and placebo groups, respectively) and remained low (mean score, 0.56 at week 104)., Conclusion: Structural damage was low at baseline and most patients showed no radiographic progression in SI joints and spine over 2 years in the secukinumab and placebo-secukinumab groups. Secukinumab reduced SI joint inflammation, which was sustained over 2 years., Trial Registration: ClinicalTrials.gov, NCT02696031., (© 2023. The Author(s).)

Objectives: Spondyloarthritis (SpA) results from the interplay between genetic and environmental factors. An emerging modifiable factor is the human intestinal microbiota, which multiple studies in children and adults have shown to be abnormal in SpA patients, including enthesitis related arthritis and ankylosing spondylitis (AS). However, HLA-B27 itself appears to impact the contents of the microbiota and is more common in SpA patients versus controls, thus serving as a confounding factor in most comparative studies., Methods: This was a cross-sectional study that evaluated the contents of the faecal microbiota among 29 patients with HLA-B27+ AS and 43 healthy adults who underwent 16S sequencing and genotyping as part of the TwinsUK Programme., Results: HLA-B27 positive+ patients and healthy controls demonstrated substantial clustering based upon diagnosis. Decreased richness was observed among the AS patients, although measures of evenness were similar. After correction for multiple comparisons, several taxa - including Faecalibacterium prausnitzii and Coprococcus - were elevated in AS patients compared to controls, even when restricted to female subjects, while Bacteroides fragilis, Ruminococcus, and Akkermansia muciniphila were depleted in AS patients., Conclusions: Consistent with some previous studies, our study demonstrates in patients with AS associations with Coprococcus, Bacteroides, and Ruminococcus. Other findings, including increased Faecalibacterium, are inconsistent with previous studies and thus potentially underscore the necessity of evaluating HLA-B27 positive controls in studies evaluating the impact of the intestinal microbiota on SpA.

Objectives: Axial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are double-blind, phase 3 trials designed to evaluate efficacy and safety of bimekizumab, a novel dual interleukin (IL)-17A and IL-17F inhibitor, across the axSpA spectrum., Methods: In parallel 52-week trials, patients with active disease were randomised 1:1 (nr-axSpA) or 2:1 (r-axSpA) to bimekizumab 160 mg every 4 weeks:placebo. From week 16, all patients received bimekizumab 160 mg every 4 weeks. Primary (Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40)) and secondary endpoints were assessed at week 16. Here, efficacy and treatment-emergent adverse events (TEAEs) are reported up to week 24., Results: 254 patients with nr-axSpA and 332 with r-axSpA were randomised. At week 16, primary (ASAS40, nr-axSpA: 47.7% bimekizumab vs 21.4% placebo; r-axSpA: 44.8% vs 22.5%; p<0.001) and all ranked secondary endpoints were met in both trials. ASAS40 responses were similar across TNFi-naïve and TNFi-inadequate responder patients. Improvements were observed in Ankylosing Spondylitis Disease Activity Score (ASDAS) states and objective measures of inflammation, including high-sensitivity C-reactive protein (hs-CRP) and MRI of the sacroiliac joints and spine. Most frequent TEAEs with bimekizumab (>3%) included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. More fungal infections (all localised) were observed with bimekizumab vs placebo; no major adverse cardiovascular events (MACE) or active tuberculosis were reported. Incidence of uveitis and adjudicated inflammatory bowel disease was low., Conclusions: Dual inhibition of IL-17A and IL-17F with bimekizumab resulted in significant and rapid improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA., Competing Interests: Competing interests: DvdH: Consulting fees from AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, and is the director of Imaging Rheumatology BV; AD: Speaker for Janssen, Novartis, and Pfizer; consultant of AbbVie, Amgen, Aurinia, BMS, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB Pharma; grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB Pharma; XB: Speaker for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB Pharma; paid instructor for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB Pharma; consultant for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB Pharma; MAB: Grant/research support from UCB; Consultant for Clementia, Grey Wolf Therapeutics, Incyte, Ipsen, Pfizer, Regeneron, and Xinthera; Speaker for Novartis; HD: Speaker for BMS, Chugai, Eli Lilly, GSK, MSD, Novartis, Pfizer, UCB Pharma; MD: Consultant for AbbVie, Eli Lilly, Novartis, Merck, Pfizer, and UCB Pharma; Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer, and UCB Pharma; DE: Consultancy and speaker fees from AbbVie, Eli Lilly, Galapagos, Novartis and UCB Pharma; KG: Consultant of AbbVie, Eli Lilly, Novartis, and UCB Pharma; grant/research support from AbbVie, Gilead, Eli Lilly, Novartis, and UCB Pharma; speakers bureau from AbbVie, Eli Lilly, Novartis, UCB Pharma; LSG: Consulting fees from AbbVie, Eli Lilly, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB Pharma; grant/research support from Novartis, Pfizer and UCB Pharma; NH: Consulting fees from AbbVie, Eli Lilly, Janssen, Novartis and UCB Pharma; MM: Consultancy fees from AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma, and research grants from AbbVie, BMS and UCB Pharma; WPM: Honoraria/consulting fees from AbbVie, Boehringer-Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, Pfizer; educational grants from AbbVie, Janssen, Novartis and Pfizer; Chief Medical Officer for CARE Arthritis; DP: Speaker for AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, and UCB Pharma; Consultant for AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB Pharma; Grant/research support from: AbbVie, MSD, Novartis, and Pfizer; MR: Speakers bureau from AbbVie, BMS, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer, UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis, UCB Pharma; TT: Consultancy fees: AbbVie, Eli Lilly, Gilead, Novartis, and Pfizer; Speaker fees: AbbVie, Astellas, BMS, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis, and Pfizer; FVdB: Consultancy fees from AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer and UCB Pharma; Speakers bureau fees from AbbVie, BMS, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma; HX: Speaker for AbbVie, Janssen, Novartis, Pfizer, and UCB Pharma; Consultant for AbbVie, Beigene, BioMap, IASO, Pfizer, and UCB Pharma; Clinical investigator for Peking-Tsinghua Center for Life Sciences; AM, UM, MO, CF, TV, AME, JSS: Employees of UCB Pharma., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate response rates at week 16 with ixekizumab in patients with radiographic axial SpA (r-axSpA) and elevated or normal/low baseline inflammation measured by serum CRP or spinal MRI using data from two randomized, double-blind, placebo (PBO)-controlled phase III trials., Methods: Biologic-naïve (COAST-V) or TNF inhibitor-experienced (COAST-W) adults with active r-axSpA received 80 mg ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W) or PBO or active reference [40 mg adalimumab every 2 weeks (ADAQ2W) in COAST-V. At week 16, patients receiving ixekizumab continued as assigned and patients receiving PBO or ADA were rerandomized 1:1 to IXEQ2W or IXEQ4W through week 52. Assessment of SpondyloArthritis international Society 40% (ASAS40) response rates were examined by baseline CRP (≤5 or &gt;5 mg/l) and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine inflammation score (&lt;2 or ≥2)., Results: In the COAST-V/W integrated dataset (N = 567), significantly more patients treated with ixekizumab achieved ASAS40 response at week 16 by CRP ≤5 mg/l (27% IXEQ4W, P &lt; 0.05; 35% IXEQ2W, P &lt; 0.01 vs 12% PBO), CRP &gt;5 mg/l (39% IXEQ4W, P &lt; 0.001; 43% IXEQ2W, P &lt; 0.001 vs 17% PBO), SPARCC MRI spine score &lt;2 (40% IXEQ4W P &lt; 0.01, 52% IXEQ2W P &lt; 0.001 vs 16% PBO), and SPARCC MRI spine score ≥2 (44% IXEQ4W P &lt; 0.001, 47% IXEQ2W P &lt; 0.001 vs 19% PBO). ASAS40 response was observed with CRP ≤5 mg/l and SPARCC MRI spine score &lt;2 with IXEQ4W (29%) and was significant with IXEQ2W (48%; P &lt; 0.05) vs PBO (13%)., Conclusion: Ixekizumab demonstrated efficacy in the treatment of AS/r-axSpA in patients with and without elevated CRP or evidence of spinal inflammation on MRI., Trial Registration: ClinicalTrials.gov (https://clinicaltrials.gov): NCT02696785, NCT02696798., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that predominantly affects the axial skeleton, although it can affect peripheral joints, and extra-musculoskeletal manifestations also occur. Historically, axSpA was thought to be a disease predominantly seen in men, although with the advent of magnetic resonance imaging techniques and advances in research, this dogma has been challenged and refuted. Sex and gender are different concepts, and both can have a role in disease. In axSpA, consideration of the influence of sex and gender on the disease phenotype is necessary to predict outcomes and to enable the development of therapeutic approaches that are best suited to individual patients., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: 52-week results from C-axSpAnd demonstrated the safety and efficacy of certolizumab pegol (CZP) in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation (sacroiliitis on MRI and/or elevated C-reactive protein levels). Long-term safety and clinical outcomes, including MRI assessments, are evaluated up to 3 years for CZP-treated patients with nr-axSpA., Methods: C-axSpAnd was a phase 3 study comprising a 1-year double-blind, placebo-controlled period and 2-year open-label safety follow-up extension (SFE). At baseline, 317 patients were randomised 1:1 to placebo or CZP 200 mg every 2 weeks. Patients completing the double-blind phase who enrolled into the SFE received open-label CZP for an additional 104 weeks. Long-term safety and clinical outcomes are reported to Week 156. Continuous outcomes are presented as observed case (OC) and dichotomous outcomes as OC and with non-responder imputation., Results: 243/317 (76.7%) patients entered the SFE, during which 149 (61.3%) experienced ≥1 treatment-emergent adverse event (TEAE); 15 (3.3/100 patient-years) experienced serious TEAEs. Continuous outcome scores (including Ankylosing Spondylitis Disease Activity Score [ASDAS]: 1.8; Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]: 2.7) at Week 52 were maintained at Week 156 (ASDAS: 1.8; BASDAI: 2.6) for the initial CZP-randomised group. Mean SPARCC MRI sacroiliac joint inflammation scores for these patients decreased at Week 52 (baseline: 7.6; Week 52: 1.7), remaining low at Week 156 (2.4)., Conclusions: CZP treatment was well tolerated up to 3 years, with no new safety signals versus previous reports. Clinical outcomes achieved after 1 year were sustained to 3 years., Trial Registration Number: NCT02552212., Competing Interests: Competing interests: DvdH: consultant of AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma. Director of Imaging Rheumatology BV. LSG: research grants from Novartis, Pfizer and UCB Pharma. Consulting fees from AbbVie, GSK, Janssen, Lilly, Novartis, Pfizer and UCB Pharma. WPM: grants from AbbVie, Novartis and Pfizer. Consulting fees from Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly and UCB Pharma. Honoraria/speakers’ bureau from AbbVie, Novartis, Pfizer and UCB Pharma. Chief Medical Officer for CARE Arthritis Limited. RL: grants from Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. Consultancy fees from Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. Honoraria/speakers’ bureau from Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. MR: consulting fees from UCB Pharma. Honoraria/speakers’ bureau AbbVie, Eli Lilly, Janssen, Novartis and UCB Pharma. Participation on a Data Safety Monitoring or Advisory Board for AbbVie, Eli Lilly, Janssen-Cilag, Novartis and UCB Pharma. LB, BH, TK, MK, SEA: employees and stockholders of UCB Pharma. AD: grants from Abbvie, Eli Lilly, GSK, Novartis, Pfizer and UCB Pharma. Consulting fees from AbbVie, Amgen, Aurinia, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma. Speaker for Janssen, Novartis and Pfizer., (© 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.)

Background: To investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex., Methods: The phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex., Results: Efficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27- subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively., Conclusions: Secukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/-) and/or MRI (+/-) status, HLA-B27 (+/-) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (-) subgroups. Male patients had higher relative responses than female patients., Trial Registration: ClinicalTrials.gov , NCT02696031 . Registered on 02 March 2016., (© 2021. The Author(s).)

Objective: Cardiovascular (CV) morbidity and mortality are increased in axial spondyloarthritis (axSpA).We conducted a cross-sectional study evaluating the 10-year atherosclerotic cardiovascular disease (ASCVD) risk in axSpA compared to the general US population., Methods: We included 211 adults, 40-75 years old with ankylosing spondylitis (AS) or nonradiographic axSpA from 2 sites, who had available data on comorbidities, medication use, blood pressure measures, and laboratory cholesterol values. General population comparators from the 2009-2014 National Health and Examination Survey (NHANES) cycles were matched 4:1 to subjects, on age, sex, and race. We estimated the prevalence ratio for a 10-year ASCVD risk score ≥ 7.5% comparing axSpA and matched NHANES comparators using conditional Poisson regression., Results: Overall, subjects were 53.9 ± 11.2 years old, 69% were male, and 74% were White. The mean 10-year ASCVD risk score was 6.7 ± 6.9% for those with axSpA, and 9.0 ± 10.5% for NHANES comparators. Compared to those with axSpA, the prevalence of current smoking and diabetes was higher among NHANES comparators. The estimated prevalence ratio for a 10-year ASCVD risk score ≥ 7.5% comparing those with axSpA and their age-, sex-, and race-matched comparators was 0.96 (95% CI 0.74-1.24)., Conclusion: The prevalence of a 10-year ASCVD risk score ≥ 7.5% was not significantly different comparing axSpA patients and those drawn from the general population who were similar in terms of age, sex, and race. Future studies should focus on improved CV risk prediction in axSpA, because underestimation by a general population risk score may potentially explain these results., (Copyright © 2021 by the Journal of Rheumatology.)

Objective: This study evaluated the effect of ixekizumab (IXE) on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biological disease-modifying antirheumatic drug (bDMARD)-naïve or failed at least 1 tumor necrosis factor inhibitor (TNFi)., Methods: In 2 multicenter, randomized, double-blind, placebo-controlled, and active-controlled (bDMARD-naïve only) trials, patients with r-axSpA were randomly assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], placebo (PBO), or adalimumab (ADA; bDMARD-naïve only). After 16 weeks, patients who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 52. Functioning and health were measured by the generic 36-item Short Form Health Survey (SF-36) and the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI). Societal health utility was assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L)., Results: At Week 16, both doses of IXE in bDMARD-naïve and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. A larger proportion of patients reaching improvement in ASAS HI ≥ 3 as well as an achievement of ASAS HI good health status was reported in patients treated with IXE. Improvements were maintained through Week 52., Conclusion: IXE significantly improved functioning and health as assessed by both generic and disease-specific measures, as well as societal health utility values in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, and improvements were sustained through 52 weeks., (Copyright © 2021 by the Journal of Rheumatology.)

Background/purpose: First-degree relatives (FDRs) of patients with ankylosing spondylitis (AS) may be at high risk of spondyloarthritis. We examined the frequency, characteristics of chronic back pain (CBP), associated features, persistence of symptoms, and HLA-B27 allele frequency in FDRs of AS patients, also comparing those FDRs with participants in NHANES 2009-2010 with CBP., Methods: 399 FDRs of AS probands were divided into: (1) No CBP (subjects >40 years old at study visit without CBP) (n=162); (2) NICBP (non-inflammatory CBP) (n=82), and (3) CIBP (inflammatory CBP) (n=155). White FDRs with CBP were compared with 772 participants in NHANES 2009-2010 with CBP. FDRs were invited to return for reassessment., Results: FDRs with CIBP had earlier onset of CBP than those with NICBP (p<0.001) and had higher frequency of heel pain than those without CBP (p=0.002). HLA-B27 occurred in 57% of FDRs with CIBP vs 39.6% of those without CBP (p=0.005, OR=1.9). Of 23 patients with CIBP at baseline re-evaluated 67.04±31.02 months later, 16 (73%) still had CIBP, whereas 4 (31%) of 13 NICBP patients seen 61.23±31.84 months later remained symptomatic., Conclusion: CIBP in FDRs of AS patients is HLA-B27-associated, has earlier onset and tends to persist compared to NICBP., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To compare the magnetic resonance imaging (MRI) morphology of inflammatory and chronic lesions in the sacroiliac joints (SIJs) and spine between patients with non-psoriatic and psoriatic non-radiographic axial spondyloarthritis (axSpA and p-axSpA, respectively)., Methods: Patients from the EMBARK trial (NCT01258738) with axSpA (n=179) and p-axSpA (n=24) who had MRI data available were compared in terms of baseline demographics, clinical characteristics, and the frequency (n/N [%]) and distribution of inflammatory and structural SIJ and spinal lesions., Results: Patients with p-axSpA were on average older (35.1 years vs. 31.7 years, p=0.047), had a higher occurrence of asymmetric sacroiliitis (54.2% vs. 29.6%, p=0.042), and a lower occurrence of human leukocyte antigen (HLA)-B27 positivity (41.7% vs. 73.7%, p=0.010) than patients with axSpA. There were no significant differences in the frequency of lesions in any of the SIJ or spinal quadrants between the two subgroups., Conclusions: These data suggest that differences between axSpA and p-axSpA extend beyond presence of psoriasis, and include age, SI symmetry, and HLAB27 status. These findings may help explain the morphotype-phenotype relationship across axSpA, similar to those described in older radiographic studies.

Objectives: To investigate the efficacy and safety of ixekizumab for up to 52 weeks in two phase 3 studies of patients with active radiographic axial spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor (TNFi)-experienced (COAST-W)., Methods: Adults with active r-axSpA were randomised 1:1:1:1 (n=341) to 80 mg ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), placebo (PBO) or 40 mg adalimumab Q2W (ADA) in COAST-V and 1:1:1 (n=316) to IXE Q2W, IXE Q4W or PBO in COAST-W. At week 16, patients receiving ixekizumab continued their assigned treatment; patients receiving PBO or ADA were rerandomised 1:1 to IXE Q2W or IXE Q4W (PBO/IXE, ADA/IXE) through week 52., Results: In COAST-V, Assessment of SpondyloArthritis international Society 40 (ASAS40) responses rates (intent-to-treat population, non-responder imputation) at weeks 16 and 52 were 48% and 53% (IXE Q4W); 52% and 51% (IXE Q2W); 36% and 51% (ADA/IXE); 19% and 47% (PBO/IXE). Corresponding ASAS40 response rates in COAST-W were 25% and 34% (IXE Q4W); 31% and 31% (IXE Q2W); 14% and 39% (PBO/IXE). Both ixekizumab regimens sustained improvements in disease activity, physical function, objective markers of inflammation, QoL, health status and overall function up to 52 weeks. Safety through 52 weeks of ixekizumab was consistent with safety through 16 weeks., Conclusion: The significant efficacy demonstrated with ixekizumab at week 16 was sustained for up to 52 weeks in bDMARD-naive and TNFi-experienced patients. bDMARD-naive patients initially treated with ADA demonstrated further numerical improvements after switching to ixekizumab. Safety findings were consistent with the known safety profile of ixekizumab., Trial Registration Number: NCT02696785/NCT02696798., Competing Interests: Competing interests: MD has served as a consultant and received research grants from AbbVie, Eli Lilly and Company, Pfizer and UCB Pharma. JC-CW has served as a consultant and/or speaker and/or has received research grants from Abbott, Bristol-Myers Squibb, Celgene, Chugai, Eisai, Eli Lilly and Company, Janssen, Novartis, Pfizer, Sanofi-Aventis, TSH Taiwan and UCB Pharma. RL has served as a consultant and/or advisor and/or has received research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Galapagos, Merck, Novartis, Pfizer and UCB Pharma. RL is the director of Rheumatology Consultancy BV, a company that was indirectly contracted by Eli Lilly and Company to perform read services for the COAST program. JS has served as a consultant and/or speaker for AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche and UCB Pharma. XB has served as a consultant and/or has received research grants from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, MSD, Novartis, Pfizer, Roche and UCB Pharma. FVdB has served as a consultant and/or speaker and/or has received research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Sanofi and UCB Pharma. WPM has served as a consultant and/or received honoraria and/or research/educational grants from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma, and is Chief Medical Officer of CARE Arthritis Limited. JE has served as a consultant and/or received research grants from AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Novartis, Pfizer, Takeda and UCB Pharma. JAW has been a consultant and/or received research grants from AbbVie, Amgen, Celgene, Eli Lilly and Company, Novartis, Pfizer and UCB Pharma. AD has been a consultant and/or received research support from AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Glaxo Smith & Klein, Janssen, Novartis, Pfizer and UCB Pharma. DvdH has been a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma and is a Director of Imaging Rheumatology BV. TT has been a consultant and speaker for AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Pfizer and Takeda. XL, FZ, CCB, GG and HC are current employees and shareholders of Eli Lilly and Company. LSG has been a consultant and/or received research grants/support from AbbVie, Amgen, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patients with spondyloarthritis with radiographic sacroiliitis are traditionally classified according to the modified New York (mNY) criteria as ankylosing spondylitis (AS) and more recently according to the Assessment of SpondyloArthritis international Society (ASAS) criteria as radiographic axial spondyloarthritis (r-axSpA)., Objective: To investigate the agreement between the mNY criteria for AS and the ASAS criteria for r-axSpA and reasons for disagreement., Methods: Patients with back pain ≥3 months diagnosed as axSpA with radiographic sacroiliitis (mNY radiographic criterion) were selected from eight cohorts (ASAS, Esperanza, GESPIC, OASIS, Reuma.pt, SCQM, SPACE, UCSF). Subsequently, we calculated the percentage of patients who fulfilled the ASAS r-axSpA criteria within the group of patients who fulfilled the mNY criteria and vice versa in six cohorts with complete information., Results: Of the 3882 patients fulfilling the mNY criteria, 93% also fulfilled the ASAS r-axSpA criteria. Inversely, of the 3434 patients fulfilling the ASAS r-axSpA criteria, 96% also fulfilled the mNY criteria. The main cause for discrepancy between the two criteria sets was the reported age at onset of back pain., Conclusion: Almost all patients with axSpA with radiographic sacroiliitis fulfil both ASAS and mNY criteria, which supports the interchangeable use of the terms AS and r-axSpA., Competing Interests: Competing interests: AM reports grants and speaker/consultancy fees from AbbVie, Pfizer, BMS, UCB and Merck, outside the submitted work; DvdH reports speaker/consultancy fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB outside the submitted work and is the Director of Imaging Rheumatology bv.; EDM reports grants and speaker/consultancy fees from AbbVie, BMS, MSD, Novartis, Pfizer, Roche and UCB outside the submitted work; DP reports grants and speaker/consultancy fees from AbbVie, MSD, Novartis and Pfizer and speaker/consultancy fees from BMS, Lilly, Roche, UCB and Celgene outside the submitted work; MR reports speaker/consultancy fees from AbbVie, BMS, Celgene, Chugai, Eli-Lily, Janssen, MSD, Novartis, Pfizer and UCB outside the submitted work; AvT reports grants from Pfizer, AbbVie, UCB and Biogen and grants and speaker/consultancy fees from Novartis outside the submitted work; FAvG reports grants from MSD, Novartis, AbbVie, the Dutch Arthritis Society, Stichting Vrienden van Sole Mio, UCB and Pfizer outside the submitted work; SR reports speaker/consultancy fees from AbbVie, Eli-Lilly, Novartis and Sanofi and grants and speaker/consultancy fees from MSD outside the submitted work. AB, AC, MD, LG and MJS have nothing to disclose. GESPIC has been financially supported by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung—BMBF), as part of the German competence network in rheumatology (Kompetenznetz Rheuma). As funding by BMBF was reduced according to schedule in 2005 and stopped in 2007, complementary financial support has been obtained also from Abbott/Abbvie, Amgen, Centocor, Schering-Plough and Wyeth. Since 2010 GESPIC is supported by Abbvie, additional support has been obtained also from ArthroMark (grants number FKZ 01EC1401A) and METARTHROS (grant number FKZ 01EC1407A) projects funded by BMBF., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Evaluate the MR distribution of inflammatory sacroiliac joint changes in axial spondyloarthritis phenotypes, including Ankylosing Spondylitis (AS) and non-radiographic Axial Spondyloarthritis (nrAxSpA)., Methods: A retrospective review of 94 patients seen for treatment of axial spondyloarthritis (SpA) who underwent sacroiliac joint MRI between January 2011 and December 2015 was performed. MR images from 68 patients (20 with AS and 48 with nrAxSpA) were reviewed independently by two radiologists. Images were scored on presence of active inflammatory and chronic structural lesions. These lesions were further categorized as unilateral, bilateral and asymmetric, or bilateral and symmetric., Results: No statistically significant difference was found in the distribution (laterality or symmetry) of bone marrow edema or sclerosis between the AS and nr-axSpA groups. Osseous erosions were more commonly bilateral symmetric in AS than nr-axSpA (11/20 vs. 8/48, p = 0.01). No statistically significant difference was noted between bone marrow edema scores in the AS and nr-axSpA subgroups (2.6 vs 3.3, p = 0.514). Patients with AS had a significantly higher fat metaplasia score compared to patients with nr-axSpA (7.3 vs 1.1, p = 0.001). Patients with nr-axSpA had a higher mean score for erosions (11.6 vs 4.2, p = 0.001). Only patients classified as AS were found to have bony ankylosis. Inter-observer reliability was strong to excellent., Conclusion: Ankylosing spondylitis findings at the sacroiliac joints are classically described as bilateral and symmetric on radiographs. Our study demonstrates that distribution on MRI at an individual time point is variable. The variable distribution should be considered when radiologists evaluate MRI exams of AS patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To update evidence-based recommendations for the treatment of patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (SpA)., Methods: We conducted updated systematic literature reviews for 20 clinical questions on pharmacologic treatment addressed in the 2015 guidelines, and for 26 new questions on pharmacologic treatment, treat-to-target strategy, and use of imaging. New questions addressed the use of secukinumab, ixekizumab, tofacitinib, tumor necrosis factor inhibitor (TNFi) biosimilars, and biologic tapering/discontinuation, among others. We used the Grading of Recommendations, Assessment, Development and Evaluation methodology to assess the quality of evidence and formulate recommendations and required at least 70% agreement among the voting panel., Results: Recommendations for AS and nonradiographic axial SpA are similar. TNFi are recommended over secukinumab or ixekizumab as the first biologic to be used. Secukinumab or ixekizumab is recommended over the use of a second TNFi in patients with primary nonresponse to the first TNFi. TNFi, secukinumab, and ixekizumab are favored over tofacitinib. Co-administration of low-dose methotrexate with TNFi is not recommended, nor is a strict treat-to-target strategy or discontinuation or tapering of biologics in patients with stable disease. Sulfasalazine is recommended only for persistent peripheral arthritis when TNFi are contraindicated. For patients with unclear disease activity, spine or pelvis magnetic resonance imaging could aid assessment. Routine monitoring of radiographic changes with serial spine radiographs is not recommended., Conclusion: These recommendations provide updated guidance regarding use of new medications and imaging of the axial skeleton in the management of AS and nonradiographic axial SpA., (© 2019, American College of Rheumatology. This article has been contributed to by US Government employees and their work is in the public domain in the USA.)

Objectives: To evaluate construct validity, interpretability, reliability and responsiveness as well as determination of cut-off points for good and poor health within the original English version and the 18 translations of the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI) in 23 countries worldwide in patients with spondyloarthritis (SpA)., Methods: A representative sample of patients with SpA fulfilling the ASAS classification criteria for axial (axSpA) or peripheral SpA was used. The construct validity of the ASAS HI was tested using Spearman correlation with several standard health outcomes for axSpA. Test-retest reliability was assessed by intraclass correlation coefficients (ICCs) in patients with stable disease (interval 4-7 days). In patients who required an escalation of therapy because of high disease activity, responsiveness was tested after 2-24weeks using standardised response mean (SRM)., Results: Among the 1548 patients, 64.9% were men, with a mean (SD) age 42.0 (13.4) years. Construct validity ranged from low (age: 0.10) to high (Bath AnkylosingSpondylitisFunctioning Index: 0.71). Internal consistency was high (Cronbach's α of 0.93). The reliability among 578 patients was good (ICC=0.87 (95% CI 0.84 to 0.89)). Responsiveness among 246 patients was moderate-large (SRM=-0.44 for non-steroidal anti-inflammatory drugs, -0.69 for conventional synthetic disease-modifying antirheumatic drug and -0.85 for tumour necrosis factor inhibitor). The smallest detectable change was 3.0. Values ≤5.0 have balanced specificity to distinguish good health as opposed to moderate health, and values ≥12.0 are specific to represent poor health as opposed to moderate health., Conclusions: The ASAS HI proved to be valid, reliable and responsive. It can be used to evaluate the impact of SpA and its treatment on functioning and health. Furthermore, comparison of disease impact between populations is possible., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Non-radiographic axial spondyloarthritis (nr-axSpA) is a complex disease process that is part of the spectrum of axial spondyloarthritis (axSpA). This article reviews the current state of the literature as the understanding of this disease spectrum expands. The conceptual history and terminology, genetics, and epidemiology are reviewed. The clinical manifestations, diagnostic approach, and measures of disease activity are examined. Finally the current treatment modalities and recommendations and the research agenda for nr-axSpA are reviewed. With the advent of new criteria, the disease spectrum can be studied in a systematic manner. These data have enriched our knowledge that reflects an earlier or milder form of disease on a spectrum same as that of ankylosing spondylitis (or radiographic axSpA). We learned how patients present in this stage and that despite an unacceptable delay in diagnosis (regardless of the stage), the burden of disease is high and unremitting. nr-axSpA clinical trials have been somewhat heterogeneous (with variable inclusion criteria) but have nevertheless shown considerable efficacy with tumor necrosis factor inhibitors and flare on withdrawal of therapy., (Published by Elsevier Ltd.)

Physical therapy and exercise (recreational activity) are the cornerstones of non-pharmacologic therapy in axial spondyloarthritis (AxSpA) [1, 2]. These are components of physical activity, though physical activity is made up of activities beyond these and also include occupational activity. Not all activities in AxSpA appear to derive the same benefit for patients. In fact, it might be that while some activities are extremely beneficial for disease activity, function, and other outcomes, other activities may be harmful for the disease. The following review will examine animal model-based evidence and epidemiologic studies on physical activity in AxSpA.

In spondyloarthritis (SpA), spontaneous remission is best described in reactive arthritis, a form of peripheral SpA. Prior SpA observational studies suggested that a significant percentage of patients reached spontaneous remission; however, these patients were followed up under older, broader European Spondyloarthropathy Study Group (ESSG) criteria or were not defined by specific criteria. In general, they were mixed populations of peripheral and axial disease, and the subsets were not differentiated when assessing end points such as remission. There are limited data on the natural history of axial SpA, in part because of the evolution of the criteria with the more recently developed Assessment of SpondyloArthritis International Society (ASAS) criteria, including the designation of non-radiographic axial SpA and peripheral SpA. Clinical trials have been conducted with various remission end points including withdrawal of therapy to determine remission maintenance. The following review addresses the potential for remission in axial and peripheral SpA based on the data from both observational studies and clinical trials., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objective: To develop and validate a reference image module aimed at calibration of readers using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) to assess radiographic progression in spondyloarthritis., Methods: Our working group comprised 6 rheumatologists and 3 musculoskeletal radiologists. The following developmental steps were conducted: (1) review of the literature to identify aspects of the mSASSS requiring methodologic clarity; (2) independent assessment of baseline and 2-year radiographs from 25 patients using the mSASSS (pilot exercise); (3) development of a training module (the Spondyloarthritis Radiography [SPAR] module) that clarifies definitions, rules, and scoring methodology and a set of reference radiographic images; (4) scoring exercise 1 by 6 readers on 39 patients, where baseline and 2-year radiographs were scored blinded to time point; and (5) revision of the SPAR module followed by scoring exercise 2 conducted by the same 6 readers on 35 patients. Reliability of status and 2-year change scores was assessed by the intraclass correlation coefficient (ICC) method., Results: ICCs for change scores for the radiologist reader pair improved from 0.46 to 0.62 after minimal calibration with the SPAR module. Recalibration from exercise 1 to exercise 2 with the SPAR module led to substantial improvement in interreader reliability for change in mSASSS score from ICC 0.44 (range 0.31-0.62) to ICC 0.62 (range 0.34-0.84). Simultaneous assessment of anteroposterior and lateral lumbar radiographs did not enhance reliability or detection of progression., Conclusion: Calibration according to the SPAR module led to improved reliability in the scoring of the mSASSS, even for expert readers., (Copyright © 2014 by the American College of Rheumatology.)

ObjectiveTo provide evidence-based recommendations for the treatment of patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (SpA).MethodsA core group led the development of the recommendations, starting with the treatment questions. A literature review group conducted systematic literature reviews of studies that addressed 57 specific treatment questions, based on searches conducted in OVID Medline (1946-2014), PubMed (1966-2014), and the Cochrane Library. We assessed the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. A separate voting group reviewed the evidence and voted on recommendations for each question using the GRADE framework.ResultsIn patients with active AS, the strong recommendations included use of nonsteroidal antiinflammatory drugs (NSAIDs), use of tumor necrosis factor inhibitors (TNFi) when activity persists despite NSAID treatment, not to use systemic glucocorticoids, use of physical therapy, and use of hip arthroplasty for patients with advanced hip arthritis. Among the conditional recommendations was that no particular TNFi was preferred except in patients with concomitant inflammatory bowel disease or recurrent iritis, in whom TNFi monoclonal antibodies should be used. In patients with active nonradiographic axial SpA despite treatment with NSAIDs, we conditionally recommend treatment with TNFi. Other recommendations for patients with nonradiographic axial SpA were based on indirect evidence and were the same as for patients with AS.ConclusionThese recommendations provide guidance for the management of common clinical questions in AS and nonradiographic axial SpA. Additional research on optimal medication management over time, disease monitoring, and preventive care is needed to help establish best practices in these areas.