INTRODUCTION: Despite of higher disease burden, lower efficacy to biologics has been reported in female compared to male patients with ankylosing spondylitis (AS). The aim of this study was to evaluate the efficacy and safety of secukinumab by sex in patients with active AS from five phase 3 studies (MEASURE 1-5) through 52 weeks. METHODS: Baseline demographics, disease characteristics and efficacy outcomes at Weeks 16 and 52 were summarized for males versus females. Baseline predictor analysis used multivariable logistic regression for binary outcome measures or generalized linear model for continuous outcome measures to assess the impact of sex as one of the independent variables on selected efficacy outcomes at Week 52. RESULTS: Overall, 1031 males and 396 females were included in this analysis. Smoking status, hs-CRP, prior exposure to TNF inhibitors, BASMI occiput-to-wall and tragus-to-wall distance (cm) were higher in males, whereas MASES was higher in females. Efficacy outcomes i.e., ASAS40 responses and BASDAI change from baseline at Weeks 16 and 52 were generally comparable between males and females. Response rates were found to be significantly higher in male patients when compared with female patients only for ASDAS-CRP inactive disease (ID) at Week 52. CONCLUSION: Comparable efficacy and safety outcomes were observed between male and female patients with active AS treated with secukinumab over 52 weeks. Further, sex was not an independent predictor of treatment response to secukinumab as assessed by ASAS40 responder rates and BASDAI change from baseline; association of ASDAS-CRP ID responder rates with sex warrants further exploration. TRIAL REGISTRATION: ClinicalTrials.gov; NCT01358175, NCT01649375, NCT02008916, NCT02159053, and NCT02896127.

Altoona Center for Clinical Research Duncansville PA USA

Department of Rheumatology ZH0D53 Amsterdam UMC VU University Medical Centre De Boelelaan 1117 1081 HV Amsterdam The Netherlands

Institute of Rheumatology and Department of Rheumatology 1st Faculty of Medicine Charles University Prague Czech Republic

NIHR Leeds Biomedical Research Centre Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds Leeds UK

Novartis Pharma AG Basel Switzerland

Novartis Pharmaceuticals Corporation East Hanover NJ USA

Oregon Health and Science University Portland OR USA

Rheumazentrum Ruhrgebiet Ruhr University Bochum Herne Germany

Université de Paris Hôpital Cochin Assistance Publique Hôpitaux de Paris Paris France

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ClinicalTrials.gov
NCT01358175, NCT01649375, NCT02008916, NCT02159053, NCT02896127