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.