Two phase 3 studies, BE OPTIMAL and BE COMPLETE, evaluated bimekizumab in adults with active psoriatic arthritis who were biologic-naïve and TNF-inadequate responders.
This article was originally published on HCPLive.
Phase 3 data from 2 studies on bimekizumab for psoriatic arthritis (PsA) will be presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 . Today, the global pharmaceutical company UCB, announced the results from the research.
The studies, BE OPTIMAL and BE COMPLETE, evaluated bimekizumab's efficacy in treating adults with active psoriatic arthritis. In BE OPTIMAL, the adults were biologic-naive, and in BE COMPLETE, adults were TNF-inadequate responders.
“Today’s findings from the BE OPTIMAL and BE COMPLETE studies provide clear evidence supporting the potential of bimekizumab, a dual IL-17A and IL-17F inhibitor, in the treatment of active psoriatic arthritis," Joseph F. Merola, MD, MMSc, Associate Professor, Harvard Medical School and Brigham and Women’s Hospital said in a statement. "This painful, chronic condition can greatly impact patients’ lives. Achieving minimal disease activity is an important goal of treatment, that can ultimately lead to improved quality of life for people with psoriatic arthritis.”
A consistent clinical response was observed across each population. Both sets of data displayed a higher proportion of patients treated with bimekizumab achieved improvements in joint symptoms at week 16 compared with placebo.
Using the ACR50 for measurement, 43.9% of those who have never been treated with a biologic before, and 43.4% of adults who had an inadequate response to TNF inhibitors had joint improvement compared with the placebo groups who reported 10% and 6.8% joint improvement, respectively.
By week 16, high levels of skin clearance were also attained by a majority proportion of patients who received the treatment. Within the biolgic-naive group, 61.3% compared with 2.9% had substantial skin clearance, while 68.8% compared with 6.8% of the TNF-inadequate responders similarly showed the placebo group with much lower success.
Overall, 40% of adults across both groups treated with bimekizumab achieved minimal disease activity compared with placebo, at week 16.
The humanized monoclonal l IgG1 antibody was designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), 2 key cytokines driving inflammatory processes.
In addition, to the 2 phase 3 studies already mentioned, bimekizumab is in development for the treatment of active axial spondyloarthritis with 24-week interim analysis results from BE MOBILE 1 (non-radiographic axial spondyloarthritis) and BE MOBILE 2 (ankylosing spondylitis) studies.
These results will also be presented at EULAR 2022.
While the safety and efficacy of bimekizumab in psoriatic arthritis has not been established and its not approved for use in this patient population by any regulatory authority worldwide, each study met their primary endpoint of ACR50, and all ranked secondary enpoints at week 16.
The results among both patient groups who received the treatment displayed improved outcomes that were statistically significant when compared with placebo. The patients in the treatment groups were administered 160 mg of bimekizumab every 4 weeks.
Both studies performed were randomized, multicenter, double-blind, placebo-controlled, with a parallel-group.
However, BE OPTIMAL was an active reference (adalimumab), parallel-group, phase 3 study that included patients with active psoritatic arthritis who were biologic disease-modifying anti-rheumatic drug (bDMARD) naive. The presented data represent the 24-week interim analysis for the study, as it's ongoing.
BE COMPLETE enrolled adults with active psoriatic arthritis and an inadequate response to tumor necrosis factor-alpha inhibitors (TNFαi). All enrolled patients had a history of inadequate response, described as a lack of efficacy after at least 3 months of therapy at an approved dose, or intolerance to treatment with 1 or 2 TNFαi for either psoriatic arthritis or psoriasis.