BIMZELX^® (Bimekizumab-bkzx) Injection, for Subcutaneous Use

BIMZELX^® (bimekizumab-bkzx) injection, for subcutaneous use, was approved in October 2023 for moderate to severe plaque psoriasis in patients aged ≥18 years. In three phase 3, randomized, double-blind, vehicle, and comparator-controlled studies (Be Vivid, Be Ready, and Be Sure), bimekizumab was investigated for the treatment of plaque psoriasis. The primary efficacy end point was psoriatic area and severity index (PASI) 90 (patients with 90% improvement in PASI from baseline) and investigator's global assessment (IGA) score of 0 (clear skin)-1 (almost clear skin) as well as ≥2-point improvement from baseline at week 16. In the Be Vivid study, patients were randomized into the bimekizumab, placebo, and ustekinumab groups. PASI 90 score was achieved by 85% (273/321) in the bimekizumab group, 5% (4/83) in the placebo group, and 50% (81/163) in the ustekinumab group. IGA 0/1 score was achieved by 84% (270/321) in the bimekizumab group, 5% (4/83) in the placebo group, and 53% (87/163) in the ustekinumab group. In the Be Ready study, patients were randomized into bimekizumab and placebo groups. PASI 90 score was achieved by 91% (317/349) in the bimekizumab group and 1% (1/86) in the placebo group. IGA 0/1 score was achieved by 93% (323/349) in the bimekizumab group and 1% (1/86) in the placebo group. In the Be Sure study, patients were randomized into two bimekizumab groups (receiving different bimekizumab regimens) and one adalimumab group. PASI 90 score was achieved by 86.2% (275/319) in combined bimekizumab groups and 47.2% (75/159) in the adalimumab group. IGA 0/1 score was achieved by 85.3% (272/319) in combined bimekizumab groups and 57.2% (91/159) in the adalimumab group. Bimekizumab was well tolerated with no unexpected safety findings.