Safety and Efficacy of Bimekizumab in Patients With Moderate-to-Severe Hidradenitis Suppurativa: A Multicenter Retrospective Cohort Study

Abstract

Background

Bimekizumab is the first and only dual selective inhibitor of IL-17 A and IL-17 F that has been proven effective and safe in Phase 3 clinical trials and has been approved by the European Medicines Agency (EMA) for the treatment of hidradenitis suppurativa (HS).

Objectives

To assess the safety and efficacy profile of bimekizumab in patients with moderate-to-severe HS across multiple centers in Spain.

Methods

We conducted a retrospective cohort study including 84 patients treated with bimekizumab. Efficacy was assessed using an intention-to-treat approach, with patients who discontinued treatment for any reason or were lost to follow-up considered nonresponders. Data were collected at baseline, week 16, and week 24.

Results

The analysis included a total of 84 patients at 16 weeks, with 43 having completed the 24-week follow-up assessment (56 men [66.67%] and 28 women [33.33%]) with a mean age of 44.17 (13.43) years and a mean baseline IHS4 of 23.75 (12.87) were included. By week 24, IHS4 scores dropped by 16.73 points (p < 0.0001); a HiSCR50 of 55.95% was achieved at week 16, which was maintained with a HiSCR50 of 55.81% at week 24; DLQI scores improved by 10.67 points (p < 0.0001); pain scores dropped by 3.42 points (p < 0.0001); and flare counts were reduced by 1.53 (p = 0.0006). Adverse events were reported in 20.24% of patients by week 16, mainly candidiasis, and dropped to 11.90% by week 24. 53.57% (45/84) of patients achieved IHS4-55 by week 16, and by week 24, 60.47% (26/43) of patients maintained or reached this response level.

Conclusions

Bimekizumab is effective for the treatment of HS in real-world clinical practice, with a manageable safety profile over the 24-week period. Our findings are consistent with those reported in phase 3 clinical trials.