“The results of the Be Optimal and Be Complete studies offer clear evidence to support the potential of bimekizumab, a dual inhibitor of Il-17A and Il-17F, in the treatment of active psoriatic arthritis. This painful and chronic disease can have a major impact. on patients’ lives. Achieving minimal disease activity is an important treatment goal, which ultimately improves the quality of life for people with psoriatic arthritis. ” Thus Joseph F. Merola, associate professor, Harvard medical school and Brigham and Women’s hospital, Boston (USA), commenting on the data of the two studies presented at the European Rheumatology Congress, Eular 2022 (Copenhagen, 1-4 June 2022).
As the pharmaceutical company Ucb, which manufactures the biological drug, explains in a note, the detailed data concern 2 Phase 3 studies that evaluated the efficacy and safety of bimekizumab compared to placebo in the treatment of adults with active psoriatic arthritis who were naïve. , that is, they had never used the disease-modifying biological antirheumatic drug – bDmard (Be Optimal) – and of adults with inadequate response or intolerance to tumor necrosis factor inhibitors – anti-Tnf-alpha (Be Complete). The safety and efficacy of bimekizumab in psoriatic arthritis had not yet been confirmed, and the drug is not currently approved for use in psoriatic arthritis by the drug’s regulatory authorities.
Both studies achieved the primary endpoint – an improvement of at least 50% from baseline in the American College of Rheumatology (Acr50) response criteria – compared to placebo at week 16 and all secondary endpoints. classified compared to placebo with statistical significance. At week 16, patients treated with bimekizumab achieved clinically relevant improvements over placebo in both joint and skin symptoms, with consistent efficacy outcomes across biologically naïve and inadequate responders to anti-TNF-alpha alone. . In addition, at week 16, in both studies, more than 40% of patients achieved minimal response to disease activity compared to placebo. The safety profile of bimekizumab was consistent with safety data observed in previous studies with no other signs observed.
“Our Phase 3 clinical trials with bimekizumab used Acr50 at week 16 as the primary endpoint, thus reflecting our goal to raise the treatment bar for people with psoriatic arthritis. The results show how bimekizumab has enabled to manage debilitating joint symptoms of active psoriatic arthritis, with even higher levels of skin clearance than placebo, “said Emmanuel Caeymaex, executive vice president, Immunology solutions and Head of Us, Ucb. “Importantly, the consistent results observed across populations suggest that bimekizumab may allow for a similar clinical response in patients who have an inadequate response or intolerance to TNF-alpha inhibitors in biologically naïve responders.”
Psoriatic arthritis is a severe, highly heterogeneous, chronic systemic inflammatory condition affecting both the joints and the skin, with a prevalence of 0.02% to 0.25% in the population and 6% to 41% in patients with psoriasis. Symptoms include: joint pain and stiffness, skin plaques, swollen fingers and toes (dactylitis), and inflammation of the sites where tendons or ligaments enter the bone (enthesitis).
Bimekizumab is a humanized monoclonal Igg1 antibody designed to selectively inhibit both interleukin 17A (Il-17A) and interleukin 17F (Il-17F), two key cytokines that drive inflammatory processes. The drug is also in Phase 3 clinical development for the treatment of active axial spondyloarthritis.
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