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

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

Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

“…Such an abundance of female patients ultimately allowed us to better grasp the role of gender in the response to secukinumab. Women are known to show poorer responses to TNFi compared to men in both AS and PsA, while the influence of gender in IL-17i responses appears more controversial [38]. In AS, male patients more frequently achieved inactive disease (ASDAS-ID response) in a post-hoc pooled analysis of all MEASURE trials, although no other efficacy outcomes were substantially affected by sex [38].…”

“…Women are known to show poorer responses to TNFi compared to men in both AS and PsA, while the influence of gender in IL-17i responses appears more controversial [38]. In AS, male patients more frequently achieved inactive disease (ASDAS-ID response) in a post-hoc pooled analysis of all MEASURE trials, although no other efficacy outcomes were substantially affected by sex [38]. Furthermore, real-world evidence with secukinumab suggests that male patients show higher retention rates than females in AS and axial SpA, either statistically [31,32] or at least numerically [39].…”

Factors associated with the retention of secukinumab in patients with axial spondyloarthritis in real-world practice: results from a retrospective study (FORSYA)

“…The findings on gender were consistent with the MEASURE studies, where efficacy and safety outcomes were comparable between male and female axSpA patients treated with secukinumab over 52 weeks. 40 In the real-word German AQUILA study in r-axSpA, the secukinumab retention rate between male and female patients was not significantly different. 41 In pooled analyses of the MEASURE studies, secukinumab was effective in patients with r-axSpA regardless of their HLA-B27 status; however, patients who were HLA-B27 positive seemed to derive increased therapeutic benefit than those who were HLA-B27 negative.…”

Female Sex, Age, and Unfavorable Response to Tumor Necrosis Factor Inhibitors in Patients With Axial Spondyloarthritis: Results of Statistical and Artificial Intelligence–Based Data Analyses of a National Multicenter Prospective Registry

“…Second, the study was focused on TNFi, and newer treatments were not analyzed due to sample size limitations. In this sense, a post hoc analysis of the pooled data from the MEASURE trials disclosed no sex differences on the response to secukinumab in axial SpA patients (9), while another study found worse responses among women (10). Third, this is an analysis of a database not specifically designed to look for sex or gender differences, so some variables with a potential influence on treatment response possibly were not collected.…”

“…For example, female patients have lower response rates to TNF inhibitors (TNFi) and a lower adherence to the treatment (4,7,8). Regarding IL‐17i, fewer data are available, and while sex was not an independent predictor of treatment response to secukinumab in 1 study (9), another study disclosed that male sex was associated with a lower risk of secukinumab discontinuation in patients with axial SpA and psoriatic arthritis (10). Several studies on sex differences in patients with axial SpA have revealed different biologic mechanisms that could hypothetically contribute to the observed differences in disease manifestations and treatment response (5,6).…”