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. 2021 Dec;8(4):1775-1787.
doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis

Irene van der Horst-Bruinsma  1 , Corinne Miceli-Richard  2 , Juergen Braun  3 , Helena Marzo-Ortega  4 , Karel Pavelka  5 , Alan J Kivitz  6 , Atul Deodhar  7 , Weibin Bao  8 , Brian Porter  8 , Effie Pournara  9
Affiliations

A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis

Irene van der Horst-Bruinsma et al. Rheumatol Ther. 2021 Dec.

Abstract

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.

Keywords: Ankylosing spondylitis; Axial spondyloarthritis; Biologics; DMARDs; Interleukins; Quality of life; Secukinumab; Sex; Spondyloarthropathies; TNF inhibitors.

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Figures

Fig. 1
Fig. 1
ASAS40 response rates and mean change from baseline in BASDAI score at Week 16 and 52 by sex. Data is presented as observed. ASAS Assessments of SpondyloArthritis international Society, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, n total number of patients evaluated in the treatment group
See this image and copyright information in PMC

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