Objective: Axial spondyloarthritis (axSpA) is a chronic inflammatory joint disease that usually presents with axial symptoms, but can also present with peripheral and extra-articular manifestations. It occurs equally in females and males. The diagnostic delay for axSpA is 5-7 years, and is significantly longer in females than in males. The aim of this study is to investigate the difference in disease characteristics between females and males with axSpA and to stratify this difference according to human leucocyte antigen (HLA)-B27 status. Method: Clinical characteristics, spondyloarthritis (SpA) features, disease activity parameters, X-rays of sacroiliac joints, and laboratory results were assessed in a real-life cross-sectional cohort of 389 patients with a clinical diagnosis of axial or peripheral SpA, and compared between genders. Results: Of 389 patients included, 313 had a clinical diagnosis of axSpA [females vs males, 131 (42%) vs 182 (58%), respectively]. Females had less radiographic axSpA according to the modified New York criteria (38.9% vs 63.7%, respectively), had a higher erythrocyte sedimentation rate [(median (interquartile range) 11 (5-23) vs 8 (3-16) mm/h), and reported higher disease activity by the Bath Ankylosing Spondylitis Disease Activity Index (mean ± sd 5.2 ± 2.1 vs 4.6 ± 2.2). No differences were found in clinical characteristics or SpA features, or when stratifying for HLA-B27 status. Conclusions: In this real-life cohort of patients with axSpA, although males more often had structural damage on X-rays, females had similar disease with regard to SpA features and at least equal disease activity parameters compared to males.

Background:Axial spondyloarthritis (axSpA) spectrum covers radiographic axSpA and non-radiographic axSpA (nr-axSpA). PREVENT (NCT02696031) is the first phase III, placebo (PBO) controlled study evaluating secukinumab (SEC) 150 mg with (LD) or without loading (NL) dose, in patients (pts) with nr-axSpA.1The study had 2 independent analysis plans as per EU (Wk 16) and US (Wk 52) regulatory requirements.Objectives:To report efficacy through Wk 52 and safety up to two years for the PREVENT study.Methods:555 pts fulfilling ASAS criteria for axSpA plus abnormal CRP and/or MRI, without evidence of radiographic changes in sacroiliac (SI) joints according to modified New York Criteria for AS were enrolled. All images were assessed centrally before inclusion. Pts were randomised (1:1:1) to SEC 150 mg with LD, NL, or PBO at baseline (BL). LD pts received SEC 150 mg at Wks 1, 2, 3, and 4, and then every 4 wks (q4wk) starting at Wk 4. NL pts received SEC 150 mg at BL and PBO at Wks 1, 2, and 3, and then 150 mg q4wk. Switch to open-label (OL) SEC 150 mg or standard of care (SoC) was permitted after Wk 20. Primary endpoint was ASAS40 at Wk 16 (LD) and at Wk 52 (NL) in anti-TNF-naïve pts. Secondary endpoints (overall population) included ASAS40, BASDAI50, SI joint bone marrow edema (BME) score by MRI at Wks 16 and 52 and ASDAS-CRP inactive disease (ID) at Wk 52. Endpoints were analysed according to statistical hierarchy. Analysis used non responder imputation through Wk 52. Safety analyses included all pts who received ≥1 dose of study treatment.Results:Overall, 481 pts completed 52 wks with no major differences in retention across groups: 84.3% (156/185; LD), 89.7% (165/184; NL) and 86.0% (160/186; PBO). BL characteristics were similar across groups; 90% pts were anti-TNF-naïve, 56-58% pts had elevated CRP, 71-75% pts had evidence of SI joint inflammation by MRI. Proportion of pts who switched to OL or SoC between Wks 20 and 48 was 52.1% (LD), 49.2% (NL), and 67.4% (PBO). Primary endpoints at Wk 16 and Wk 52 were met (Table). SEC 150 mg LD or NL significantly improved secondary endpoints at Wk 16 and 52 vs PBO (Table). SEC significantly reduced SI joint MRI BME score vs PBO at Wk 16 (-1.68 and -1.03 vs -0.39;P= 0.0197 and 0.026, LD and NL respectively). No unexpected safety signals were reported.Conclusion:SEC 150 mg provided significant and sustained improvement in signs and symptoms of pts with nr-axSpA through Wk 52. MRI BME scores were reduced accordingly. There was no major difference between LD and NL. Safety of SEC was consistent with previous reports.2References:[1]Deodhar A, et al.Arthritis Rheumatol. 2019;71(suppl 10).[2]Deodhar A, et al. Arth Res Ther. 2019;21:111.TableEndpoints, % respondersWkSEC150 mg LD(N = 185)SEC150 mg NL(N = 184)PBO(N = 186)PrimaryASAS40 in anti-TNF-naïve pts1641.5‡42.2‡29.25235.4‡39.8‡19.9SecondaryASAS401640.0‡40.8‡28.05233.5‡38.0‡19.4BASDAI501637.3‡37.5‡21.05230.8‡35.3‡19.9ASDAS-CRP ID1620.5†21.7†8.15215.723.9‡10.2†P< 0.001;‡P< 0.05 vs PBO (Pvalues are adjusted for multiplicity of testing at Wks 16 and 52. UnadjustedPvalue for ASDAS-CRP ID at Wk 16). Missing values were imputed as non-response.N, number of randomised ptsDisclosure of Interests:Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Ricardo Blanco Grant/research support from: AbbVie, MSD, Roche, Consultant of: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Speakers bureau: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma. MSD, Eva Dokoupilova Grant/research support from: Eli Lilly, AbbVie, Novartis, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim, Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Stephen Hall Grant/research support from: Abbvie, UCB, Janssen, Merck, Hideto Kameda Grant/research support from: Abbvie, Asahi-Kasei, Chugai, Eisai, Mitsubishi-Tanabe and Novartis, Consultant of: Abbvie, Boehringer, Celgene, Eli Lilly, Janssen, Novartis, Sanofi, UCB, Speakers bureau: Abbvie, Asahi-Kasei, BMS, Chugai, Eisai, Eli Lilly, Janssen, Mitsubishi-Tanabe, Novartis and Pfizer, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Marleen van de Sande Grant/research support from: Novartis, Eli Lilly, Boehringer Ingelheim, Janssen, Consultant of: Abbvie, Novartis, Eli Lilly, Speakers bureau: Novartis, MSD, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Anna Wiksten Shareholder of: Novartis, Employee of: Novartis, Brian Porter Shareholder of: Novartis, Employee of: Novartis, Hanno Richards Shareholder of: Novartis, Employee of: Novartis, Sibylle Haemmerle Shareholder of: Novartis, Employee of: Novartis, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB

BackgroundInflammation shown on MRI of the sacroiliac joint (MRI-SI) is prevalent in axSpA (±30%) but the specificity is not well known.ObjectivesTo compare MRI of the sacroiliac joints (MRI-SI) of healthy, symptomless individuals and those with known mechanical strain acting upon SI joints to axial spondyloarthritis (axSpA) and chronic back pain (CBP) patients.MethodsThree trained, calibrated and blinded readers randomly scored MRI-SI of 172 subjects: 47 healthy individuals without current/past back pain(;1 47 axSpA patients from the SPondyloArthritis Caught Early (SPACE) cohort (with a previously confirmed positive MRI-SI); 47 CBP controls (irrespective of MRI-SI results) from the SPACE cohort; 7 women with postpartum back pain; and 24 frequent runners. Readers scored according to the ASAS definition and SPARCC score.ResultsOf the 47 healthy volunteers, 11 (23.4%) had a positive MRI-SI, compared to 43 of 47 (91.5%) positive axSpA patients and 3 of 47 (6.4%) CBP patients. Of the runners, 3 of 24 (12.5%) and of the women with postpartum back pain 4 of 7 (57.1%) had a positive MRI-SI. Using a SPARCC cut-off of ≥2 for positivity, 12/47 and healthy volunteers (25.5%), 46/47 positive axSpA patients (97.9%), 5/47 CBP controls (10.6%), 4/24 runners (16.7%) and 4/7 women with postpartum back pain (57.1%) were positive. ‘Deep’ BME-lesions were not found in healthy volunteers, CBP patients and runners, but in 38 of 47 positive axSpA patients (80.9%) and in 1 of 7 women with postpartum back pain (14.3%).ConclusionsA substantial proportion of healthy individuals without current/past back pain has a positive MRI-SI according to the ASAS definition. Deep (extensive) BME lesions are exclusively found in axSpA patients.Reference[1] van Hoeven L, Luime JJ, et al. Bone marrow edema and structural lesions in the sacroiliac joint in a large cohort of patients with axial spondyloarthritis, chronic low back pain and healthy controls. ACR Annu Meet2013;2889.Disclosure of InterestNone declared