Bimekizumab demonstrated at ACR Convergence 2022, sustained clinical responses to week 52 in phase III studies in psoriatic arthritis
UCB, announced the first presentation of long-term, 52-week data from three Phase III studies evaluating the efficacy and safety of bimekizumab in adults with active psoriatic arthritis (PsA) who were biologic-naïve (BE OPTIMAL), in adults with active non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1), and in adults with active ankylosing spondylitis, also known as radiographic axSpA (AS; BE MOBILE 2)
These late-breaking data are being presented at ACR Convergence 2022 in Philadelphia, November 10–14, 2022.
Data from BE OPTIMAL showed that clinical joint and skin clearance responses in patients with active psoriatic arthritis were sustained to week 52 with bimekizumab treatment.These outcomes were consistent across both TNF-inhibitor (TNFi) naïve and TNFi-inadequate responder populations. In all three studies, the adverse event profile of bimekizumab was consistent with data seen in previous studies with no new observed signals.
BE OPTIMAL (PsA): Phase III Study Results (52 weeks); In BE OPTIMAL, patients were randomized (3:2:1) to bimekizumab (160 mg every four weeks [Q4W]; N=431), placebo (N=281) or the active reference arm (adalimumab 40 mg every two weeks [Q2W]; N=140). Patients initially randomized to placebo were switched to bimekizumab at week 16. A total of 89.3 percent of randomized patients completed week 52. Key 52-week results from the BE OPTIMAL study are presented below and build upon previously announced 16- and 24-week results. ACR50: At week 52, 54.5 percent of patients continuously treated with bimekizumab, 53.0 percent of patients who switched from placebo to bimekizumab at week 16, and 50.0 percent of patients in the reference arm (adalimumab) achieved ACR50. Complete Skin Clearance (PASI 100): At week 52, in patients with baseline psoriasis greater than 3 percent body surface area, 60.8 percent of patients continuously treated with bimekizumab, 65.0 percent of patients who switched from placebo to bimekizumab at week 16, and 48.5 percent of patients in the reference arm (adalimumab) achieved PASI 100. Minimal Disease Activity (MDA): At week 52, 55.0 percent of patients continuously treated with bimekizumab, 53.7 percent of patients who switched from placebo to bimekizumab at week 16, and 52.9 percent of patients in the reference arm (adalimumab) achieved MDA.
“The long-term bimekizumab data presented at ACR Convergence 2022 in patients with psoriatic arthritis show clinically meaningful improvements in joint and skin outcomes through to one year. In BE OPTIMAL, at week 52, over six out of 10 patients treated with bimekizumab achieved complete skin clearance and one in two patients achieved minimal disease activity. Long-term data such as these are important since they may help to inform clinical decision making of the future,” said Christopher Ritchlin MD, MPH, Professor of Medicine and faculty member in the Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, New York, U.S.
Over 52 weeks, 79.1 percent of patients treated with bimekizumab had greater than one treatment emergent adverse event (TEAE) and 80.7 percent on adalimumab. The three most frequent TEAEs with bimekizumab treatment were nasopharyngitis (12.0 percent), upper respiratory tract infection (7.1 percent) and urinary tract infection (6.1 percent).
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