Bimekizumab was found to be superior to placebo in the improvement of skin and joint symptoms among patients with active psoriatic arthritis (PsA), according to study findings published in Lancet.
Bimekizumab is a humanized monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F and prevents development of proinflammatory cytokine responses observed in the skin lesions of patients with PsA.
Researchers conducted a randomized, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE; ClinicalTrials.gov Identifier: NCT03896581) between March 2019 and February 2022 across 11 countries and 92 sites. They compared the safety and efficacy of bimekizumab with placebo after 16 weeks in patients with active PsA with a prior inadequate response or intolerance to tumor necrosis factor-α (TNFα) inhibitors.
The researchers also assessed dermatologic outcomes with bimekizumab in patients with psoriasis with at least 3% of body surface area affected by PsA at baseline. Improvements of 90% or greater on the Psoriasis Area and Severity Index (PASI90) were considered as significant.
The primary endpoint was 50% or greater improvement of the American College of Rheumatology criteria (ACR50) at week 16.
Of the 400 patients with PsA enrolled in the analysis, 267 were randomly assigned to the bimekizumab group and 133 to the placebo group. Patients in the treatment group received 160 mg of bimekizumab subcutaneously every 4 weeks for 16 weeks.
At week 16, 43% (n=116/267) of patients receiving bimekizumab achieved ACR50 compared with 7% (n=9/133) of patients in the placebo group (adjusted odds ratio [aOR], 11.1; 95% CI, 5.4-23.0, P <.0001).
Among patients in the bimekizumab group with at least 3% body surface area affected by PsA at baseline, 69% (n=121/176) achieved 90% or greater improvements on the PASI90 compared with 7% (n=6/88) in the placebo group (aOR, 30.2; 95% CI, 12.4-73.9; P <.0001).
Treatment-emergent adverse events occurred in 40% (n=108/267) of patients in the bimekizumab group and 33% (n=44 of 132) in the placebo group. No deaths were reported. None of the adverse events, including neutropenia, hepatic events, injection site reactions, and infections, caused discontinuation of treatment.
Study limitations included the lack of generalizability to patients with comorbid conditions and PsA in real-world settings and the lack of comparison of bimekizumab with other available PsA treatments.
“The safety profile of bimekizumab was consistent with previous phase 3 studies in patients with plaque psoriasis, and studies of IL-17A inhibitors,” the study authors concluded.
Disclosures: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see original article for full list of disclosures.
Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. Published online December 5, 2022. doi:10.1016/S0140-6736(22)02303-0