Trial Data Suggests Bimekizumab Leads to Joint, Skin Improvements for Psoriatic Arthritis

Joseph F. Merola, MD,

Phase 3 trial data on bimekizumab showed that the drug led to superior joint and skin improvements by 16 weeks for psoriatic arthritis patients who had inadequately responded to TNFα inhibitors.

The BE COMPLETE study's investigators noted that psoriatic arthritis requires treatment of both the musculoskeletal and skin elements to improve outcomes, and developing an intolerance to normal treatments was noted as a troubling factor.

This latest bimekizumab study was led by Joseph F. Merola, MD, vice chair of Clinical Trials and Innovation in the department of dermatology at Brigham and Women’s Hospital. Merola also recently presented trial data on bimekizumab’s use on plaque psoriasis.

“We evaluated the efficacy and safety of bimekizumab in two phase 3 clinical trials, which were run in parallel in overlapping countries and sites, in patients with psoriatic arthritis who were naive to biologic DMARDs (BE OPTIMAL) or in patients with inadequate response or intolerance to TNFα inhibitors (BE COMPLETE),” Merola and colleagues wrote.

Background

The investigators’ research consisted of a 16-week, multicenter, phase 3, randomized, placebo-controlled, double blind trial examining the efficacy and safety of treating psoriatic arthritis patients with subcutaneous bimekizumab 160 mg every 4 weeks, compared with placebo.

Their research was performed at 92 different sites in 11 total countries, with the investigators recruiting 400 patients between MArch of 2019 and February of 2022. The study participants were randomly assigned for treatment with bimekizumab (n=267) or placebo (n=133).

The recruitment criteria for participants included in the BE COMPLETE trial was that patients were required to be 18 or older and to have adult-onset psoriatic arthritis for a minimum of 6 months prior to their recruitment. They also were required to have had either inadequate responses or intolerance to 1 or 2 TNFα inhibitors for psoriasis or psoriatic arthritis.

Findings

The study’s results indicated that the primary endpoints were met by 16 weeks, with 43% (116) out of the 267 patients given the treatment meeting the requisite American College of Rheumatology criteria (ACR50). The researchers noted that 7% of the placebo arm met ACR50, (adjusted odds ratio [OR] 11·1 [95% CI 5·4 – 23·0], P < 0·0001).

The investigators also found that a 90% or more improvement score in the Psoriasis Area and Severity Index (PASI90) wasd reported by almost 70% of study participants treated with bimekizumab with psoriasis affecting a minimum of 3% body surface area at baseline. This was compared with 7% of the 88 study participants in the placebo arm (adjusted OR 30·2 [12·4 – 73·9], P < 0·0001).

The research team also noted the safety profile of bimekizumab, reporting its consistency with prior studies for plaque psoriasis patients as well as IL-17A inhibitor trials.

“Bimekizumab treatment responses were rapid, with numerically higher responder rates compared with placebo observed as early as week 4 (after a single dose of bimekizumab), for outcomes across psoriatic arthritis manifestations, including joints, skin, and the MDA composite,” they wrote.

The study, “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),” was published online in The Lancet.