In a pair of phase 3 trials, bimekizumab — a monoclonal immunoglobulin G1 antibody that inhibits interleukin (IL)-17A and -17F — was superior to active control and placebo for treating patients with psoriatic arthritis. The BE OPTIMAL trial included patients who were naive to biologic disease-modifying antirheumatic drugs (DMARDs); the BE COMPLETE trial assessed outcomes with the agent in patients with psoriatic arthritis and inadequate response or intolerance to TNFα inhibitors. “This study showed that bimekizumab treatment resulted in clinically meaningful and consistent improvements across joint, skin, radiographic, and patient-reported outcomes in biologic DMARD-naive patients with active psoriatic arthritis,” conclude the BE OPTIMAL investigators. “Long-term data will be reported to week 52, as well as from the open-label extension study, to assess the safety and efficacy of bimekizumab in psoriatic arthritis.”
Bimekizumab was tested in 14 countries against a placebo and active control, adalimumab, in the BE OPTIMAL trial. The adult participants had these outcomes in a 52-week trial: “Between April 3, 2019, and Oct 25, 2021, 1,163 patients were screened and 852 were randomly assigned to bimekizumab (n = 431), placebo (n = 281), and reference (adalimumab; n = 140) groups. At week 16, significantly more patients receiving bimekizumab (189 [44%] of 431) reached ACR50 [50% or greater improvement in American College of Rheumatology criteria] response versus placebo (28 [10%] of 281; odds ratio 7.1 [95% CI 4.6–10.9], P <0.0001; adalimumab 64 [46%] of 140). All secondary hierarchical endpoints were met. Treatment-emergent adverse events up to week 16 were reported in 258 [60%] of 431 patients receiving bimekizumab, 139 [49%] of 281 patients receiving placebo, and 83 [59%] of 140 patients receiving adalimumab. No deaths occurred.”
At 92 sites in 10 European countries and the U.S., BE COMPLETE participants were adults with adult-onset psoriatic arthritis and a history of inadequate response or intolerance to treatment with 1 or 2 TNFα inhibitors for either psoriatic arthritis or psoriasis. The results showed the following: “Between March 28, 2019, and Feb 14, 2022, 556 patients were screened and 400 patients were randomly assigned to bimekizumab 160 mg every 4 weeks (n = 267) or placebo (n = 133). The primary and all hierarchical secondary endpoints were met at week 16. 116 (43%) of 267 patients receiving bimekizumab reached ACR50, compared with nine (7%) of 133 patients receiving placebo (adjusted odds ratio [OR] 11.1 [95% CI 5.4–23.0], P <0.0001). 121 (69%) of 176 patients with psoriasis affecting at least 3% body surface area at baseline who received bimekizumab reached 90% or greater improvement in the Psoriasis Area and Severity Index (PASI90), compared with six (7%) of 88 patients who received placebo (adjusted OR 30.2 [12.4–73.9], P <0.0001). Treatment-emergent adverse events up to week 16 were reported in 108 (40%) of 267 patients receiving bimekizumab and 44 (33%) of 132 patients receiving placebo. There were no new safety signals and no deaths.”