UK: Bimekizumab was shown to be noninferior and superior to adalimumab in reducing signs and symptoms of plaque psoriasis in a 56-week trial. However, bimekizumab was associated with a higher frequency of diarrhea and oral candidiasis.
The findings of the study were reported at the American College of Dermatology virtual meeting 2021 and simultaneously published in the New England Journal of Medicine.
Bimekizumab, a monoclonal IgG1 antibody, selectively inhibits interleukin-17A and interleukin-17F. The safety and efficacy of bimekizumab as compared with the tumor necrosis factor inhibitor adalimumab has not been extensively examined in patients with moderate-to-severe plaque psoriasis. Richard B. Warren, University of Manchester, Manchester, United Kingdom, and colleagues conducted this study to determine the same.
478 patients with moderate-to-severe plaque psoriasis were randomly assigned in a ratio of 1:1:1 to receive subcutaneous bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks (n=158); bimekizumab at a dose of 320 mg every 4 weeks for 16 weeks, then every 8 weeks for weeks 16 to 56 (n=161); or subcutaneous adalimumab at a dose of 40 mg every 2 weeks for 24 weeks, followed by bimekizumab at a dose of 320 mg every 4 weeks to week 56 (n=159).
The primary end points were a 90% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI 90 response; PASI scores range from 0 to 72, with higher scores indicating worse disease) and an Investigator's Global Assessment (IGA) score of 0 or 1, signifying clear or almost clear skin (scores range from 0 [clear skin] to 4 [severe disease]), at week 16.
Key findings of the study include:
At week 16, a total of 275 of 319 patients (86.2%) who received bimekizumab (both dose groups combined) and 75 of 159 (47.2%) who received adalimumab had a PASI 90 response (adjusted risk difference, 39.3 percentage points).
A total of 272 of 319 patients (85.3%) who received bimekizumab and 91 of 159 (57.2%) who received adalimumab had an IGA score of 0 or 1 (adjusted risk difference, 28.2 percentage points).
The most common adverse events with bimekizumab were upper respiratory tract infections, oral candidiasis (predominantly mild or moderate as recorded by the investigator), hypertension, and diarrhea.
"In this 56-week trial, bimekizumab was noninferior and superior to adalimumab through 16 weeks in reducing symptoms and signs of plaque psoriasis but was associated with a higher frequency of oral candidiasis and diarrhea," concluded the authors. "Longer and larger trials are required to determine the efficacy and safety of bimekizumab as compared with other agents in the treatment of plaque psoriasis."
Reference:
The study titled, "Bimekizumab versus Adalimumab in Plaque Psoriasis," is published in the New England Journal of Medicine.
DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2102388