Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A and interleukin 17F.

Two new studies highlight the efficacy and safety of bimekizumab in the treatment of adults with active psoriatic arthritis who were biologic-naïve and/or tumor necrosis factor inhibitor inadequate responders (TNFi-IR).

The 24-week results from the Phase 3 BE OPTIMAL study and 16-week results from the Phase 3 BE COMPLETE study evaluated the efficacy and safety of bimekizumab in the treatment of adults with active psoriatic arthritis who were biologic-naïve and tumor necrosis factor inhibitor inadequate responders (TNFi-IR), respectively.

Both studies appear in The Lancet. 

A significantly higher proportion of patients treated with bimekizumab achieved improvements in joint symptoms at week 16 compared with placebo – as measured by ACR50, the primary endpoint – with a consistent clinical response observed in both biologic-naïve and TNFi-IR populations. In addition, at week 16, a significantly higher proportion of bimekizumab-treated patients compared with placebo achieved high levels of skin clearance – as measured by PASI 90, a secondary endpoint – with a consistent clinical response in both populations. The safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.

In September 2022, UCB announced that the European Medicines Agency had accepted the marketing authorization application for bimekizumab for the treatment of active psoriatic arthritis in adults.   The efficacy and safety of bimekizumab in the treatment of psoriatic arthritis have not been established and it is not approved for the treatment of psoriatic arthritis by any regulatory authority worldwide.

About BE OPTIMAL

BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled, active reference (adalimumab), parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active psoriatic arthritis, who are biologic disease-modifying anti-rheumatic drug naïve. For additional details on the study, see article in The Lancet.

About BE COMPLETE

BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with active psoriatic arthritis and an inadequate response to tumor necrosis factor-alpha inhibitors (TNFαi). All enrolled study participants had a history of inadequate response (lack of efficacy after at least three months of therapy at an approved dose) or intolerance to treatment with one or two TNFαi for either psoriatic arthritis or psoriasis. For additional details on the study, see article in The Lancet.

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.

In August 2021, bimekizumab was approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Jennifer Soung, MD, FAAD, director of clinical research at Southern California Dermatology in Santa Ana, CA, and a clinical professor at Harbor–UCLA, discusses bimekizumab in a recent article about the psoriasis pipeline.