Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study.

Autor: Youn SW; Department of Dermatology, Seoul National University Bundang Hospital, Seongnam, Korea., Jo SJ; Department of Dermatology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea., Park CJ; Department of Dermatology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea., Kim DH; Department of Dermatology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea., Shin BS; Department of Dermatology, Chosun University Hospital, Gwangju, Korea., Jeong KH; Department of Dermatology, Kyung Hee University College of Medicine, Seoul, Korea., Bang CH; Department of Dermatology, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea., Cross N; UCB Pharma, Morrisville, North Carolina, USA., Thirlwell J; Allegis Group, Bracknell, UK.; UCB Pharma, Slough, UK., Hoepken B; UCB Pharma, Monheim, Germany.
Jazyk: angličtina
Zdroj: The Journal of dermatology [J Dermatol] 2024 Nov; Vol. 51 (11), pp. 1392-1403. Date of Electronic Publication: 2024 Sep 27.
DOI: 10.1111/1346-8138.17446
Abstrakt: Bimekizumab treatment has demonstrated significant improvements in clinical outcomes in patients with moderate to severe plaque psoriasis; however, studies so far have focused on predominantly White patient populations from North America and Europe, with one smaller study in a Japanese population. Here, clinical responses, safety, and tolerability of bimekizumab treatment in Korean patients are reported. Korean patients with moderate to severe plaque psoriasis were randomized to bimekizumab 320 mg every 4 weeks (Q4W) or placebo Q4W to week 16. Co-primary efficacy end points were achievement of ≥90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) and Investigator's Global Assessment score of 0/1 (clear/almost clear) at week 16. Secondary efficacy end points included achievement of PASI 75 at week 4 and Dermatology Life Quality Index 0/1 at week 16. Safety outcomes were also assessed. Statistical analysis of the co-primary efficacy end points was performed using a type I error rate, at a two-sided α level of 0.05. Overall, 47 Korean patients were randomized to treatment (bimekizumab: 32, placebo: 15). At week 16, bimekizumab-treated patients had significantly higher clinical responses versus placebo-treated patients (PASI 90: 81.3% vs. 0%; IGA 0/1: 87.5% vs. 0%, p < 0.001 for both). Bimekizumab showed a rapid onset of clinical response, with 75.0% of patients achieving PASI 75 by week 4 (0% in placebo patients [nominal p < 0.001]). A higher proportion of bimekizumab-treated patients achieved DLQI 0/1 at week 16 (46.9% vs. 6.7% in placebo patients, nominal p = 0.007), indicating greater improvements in health-related quality of life (HRQoL) following bimekizumab treatment. Bimekizumab was well-tolerated in Korean patients, with no new safety signals identified. Treatment with bimekizumab led to rapid improvements in clinical responses and HRQoL versus placebo in Korean patients, consistent with responses in global populations. These findings suggest that bimekizumab is an effective and well-tolerated treatment option in Korean patients with psoriasis.
(© 2024 The Author(s). The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)
Databáze: MEDLINE
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