Safety and Efficacy of Bimekizumab in Patients With Moderate-to-Severe Hidradenitis Suppurativa: A Multicenter Retrospective Cohort Study.
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Mansilla-Polo M, Pons-Benavent M, Fernández-Crehuet P, Vilarrasa E, Albanell-Fernández C, Morales-Tedone E, Rausell-Félix F, Alcalá-García R, Matellanes-Palacios M, Martín-Ezquerra G, Alfageme F, Ciudad-Blanco C, López-Villaescusa M T, Segura-Palacios J M, Pascual-Ramírez J C, Fernández-Díaz M L, Falkenhain-López D, García-Gil M, Agustí-Mejías A, No-Pérez N, Naranjo-Guerrero N, Estenaga-Pérez Á, García-Ruiz R, Mahiques-Santos L, Garbayo-Salmons P, Martorell A, Escutia-Muñoz B, Martín-Torregrosa D, Cuenca-Barrales C, Paniego C Ureña, Botella-Estrada R, Molina-Leyva A, Spanish hidradenitis suppurativa group (GEHS)
Аннотация
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.