Commentary
Video
Author(s):
Mease discussed the importance of comparator studies in a growing treatment landscape for PsA.
In September 2024, the FDA approved bimekizumab-bkzx (BIMZELX) for treating active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS) in adults.1
BIMZELX’s approval for active PsA was supported by data from the phase 3 the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials, in which BIMZELX met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints, with consistency across both biologic-naïve and TNF inhibitor‑inadequate responder (TNFi-IR) patients.
The approval further expands the treatment landscape for PsA and more research is needed to make the best informed treatment decisions for patients.
“We always welcome companies mounting head-to-head studies, but we know that that takes quite a few patients to conduct those studies, and it's quite expensive,” Philip Mease, MD, Clinical Professor, University of Washington School of Medicine and Director, Rheumatology Research, Swedish Medical Center, told HCPLive®.
In recent research led by Mease, the BE OPTIMAL and BE COMPLETE studies were compared against the PSUMMIT 1 (NCT01009086) and PSUMMIT 2 trials (NCT01077362) of ustekinumab, and the KEEPsAKE-1 (NCT03675308) and KEEPsAKE-2 (NCT03671148) trials of risankizumab to compare outcomes in people with PsA. The analysis supported the use of bimekizumab over ustekinumab or risankizumab in patients who were biologic disease-modifying anti-rheumatic drug naïve (bDMARD naïve), or who had a previous inadequate response or an intolerance to tumor necrosis factor inhibitors (TNFi-IR disease).2,3