Introduction: Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory skin disease that severely impacts patients' quality of life. Bimekizumab, the first dual inhibitor of interleukin (IL)-17A and IL-17F, has shown efficacy in phase 3 clinical trials and is currently approved for moderate-to-severe HS. However, long-term data in real-world clinical settings are lacking.
Methods: This was a multicenter, retrospective observational study of 78 adult patients with moderate-to-severe HS treated with bimekizumab. Outcomes included International Hidradenitis Suppurativa Severity Score System (IHS4), IHS4-55/75/90/100 response, pain, flare frequency, and safety through week 48.
Results: The mean age was 48.5 years, 60.3% (47/78) were classified as Hurley stage III. At week 24, results for IHS4-55, IHS4-75, and IHS4-90 were 54.7% (29/53), 41.5% (22/53), and 3.8% (2/53), respectively. At week 24, results for IHS4-55, IHS4-75, and IHS4-90 were 67.9% (53/78), 30.7% (24/78), and2.5% (2/78), respectively. At week 48, 56 patients were included, of whom 82.1% (46/56) reached an IHS4-55 response, 62.5% (35/56) an IHS4-75, 32,1% (18/56) an IHS4-90, and 23.2% (13/56) a complete response (IHS4-100). Patients unavailable for analysis had either not yet reached follow-up, 72.7% (16/22), or had discontinued treatment, 27.2% (6/22). Combination therapy in any form was more frequent in Hurley III patients, who had similar efficacy compared to Hurley II patients in terms of IHS4-55 at week 48. Adverse events occurred in 43.6% (34/78) of patients, mostly mild to moderate fungal infections (26.9%, 21/78) and eczematous reactions (9%, 6/78). During follow-up, eight patients (10.3%) discontinued treatment, primarily as a result of lack of efficacy (6.4%, 5/78).
Conclusion: Bimekizumab shows sustained clinical effectiveness and a manageable safety profile for moderate-to-severe HS in real-world practice up to 48 weeks. In our setting, the combination of medical and surgical treatment is frequently used and may contribute to improved effectiveness, particularly in patients with extensive structural damage.
Keywords: Bimekizumab; Biologic therapy; Effectiveness; Hidradenitis suppurativa; Real-world evidence; Safety.
© 2025. The Author(s).