Bimekizumab is Safe and Effective in Treating Patients With Psoriatic Arthritis Native to Biologic Treatment, Study Finds

Bimekizumab improves joint, skin, and radiographic efficacy outcomes after 16 weeks compared with the placebo in patients with psoriatic arthritis who were naïve to biologic disease-modifying antirheumatic drugs (DMARDs), with a safety profile consistent with previous phase 3 studies, according to a study published in The Lancet.

“Bimekizumab showed greater improvements across multiple key domains of psoriatic arthritis, including joints and skin, to week 16 compared with placebo, and responses were improved or sustained to week 24,” wrote corresponding author Prof Iain McInnes, MD, College of Medical Veterinary and Life Sciences, University of Glasgow in Glasgow G12 8QQ, UK, and coauthors.

The BE OPTIMAL study is the first phase 3 clinical trial to evaluate the safety and effectiveness of subcutaneous bimekizumab (160 mg every four weeks) in patients with active psoriatic arthritis who have not been treated with biologic DMARDs. The study was conducted between April 3, 2019, and October 25, 2021, and included an active reference group that received adalimumab (40 mg every two weeks). However, the study was not designed to compare the statistical differences between the two drugs.

At week 16, 44% of patients receiving bimekizumab met the primary endpoint of 50% improvement in the American College of Rheumatology response criteria (ACR50) compared with 10% of those receiving placebo. In addition, patients receiving bimekizumab showed significantly higher response rates than those receiving the placebo for all ranked secondary endpoints across joint, skin, and radiographic outcomes at week 16. Patients who switched from placebo to bimekizumab at week 16 showed improved outcomes at week 24, and responses of those remaining on bimekizumab were improved or sustained from week 16. The safety profile of bimekizumab in patients with psoriatic arthritis in BE OPTIMAL was consistent with that observed in the phase 2b BE ACTIVE study and studies of bimekizumab for other indications. Treatment-emergent adverse events were reported in 60% of patients receiving bimekizumab, 49% receiving placebo, and 59% receiving adalimumab up to week 16. No deaths occurred.

“The results presented here support previous findings showing the clinical effectiveness and tolerability of dual inhibition of IL-17A and IL-17F with bimekizumab in patients with active psoriatic arthritis,” wrote study authors.

Reference

McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25-37. doi:10.1016/S0140-6736(22)02302-9