Bimekizumab demonstrates positive results in patients with psoriatic arthritis
Posted: 10 June 2016 | | No comments yet
In a Phase Ib study, bimekizumab showed fast and sustained efficacy on disease activity measures in both skin and joints and was well-tolerated…
UCB has presented results at EULAR from a Phase Ib study bimekizumab in patients with psoriatic arthritis.
The study evaluate pharmacokinetics, safety, tolerability and preliminary efficacy of multiple doses of the therapy in patients with PsA who had inadequate responses to at least one disease-modifying anti-rheumatic drug (DMARD) and/or one biologic.
In the study, a total of 52 patients were randomised to receive either bimekizumab or placebo. In the Phase Ib study with a limited patient and exposure set, bimekizumab showed fast and sustained efficacy on disease activity measures in both skin and joints and was well-tolerated.
Commenting on the findings, Dominique Baeten, M.D., Ph.D., Professor at the Department of Clinical Immunology and Rheumatology of the Academic Medical Centre/University of Amsterdam, said: “These data strengthen our understanding of bimekizumab and how its unique mechanism of action, which inhibits both IL-17A and IL-17F cytokines, could provide clinical benefits to patients living with immunological diseases such as PsA. PsA is a very serious disease with a broad range of symptoms, including swelling and pain in the joints, which can significantly impact a patient’s life. While we’ve seen advancements in the treatment of PsA with the introduction of biologics, it’s crucial that we keep looking for newer and potentially better ways to control this devastating condition, especially in patients who aren’t responding to existing therapies.”
Bimekizumab inhibits both IL-17A and IL-17F
Bimekizumab is an investigational humanised IgG1 monoclonal antibody specifically designed to potently and selectively inhibit the biological function of both IL-17A and IL-17F, which are key pro-inflammatory cytokines involved in chronic inflammatory processes driving the pathophysiology of many severe diseases including skin and joint disorders, like PsA.
Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB, commented on the results of the study: “With these study results, we can now confidently focus on progressing the bimekizumab clinical programme and look forward to extending our robust immunology pipeline as part of our continued commitment to bringing more targeted treatment options to this patient community.”
The study evaluated multiple doses of bimekizumab compared to placebo for safety, tolerability, and efficacy, as measured by Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) score. Bimekizumab demonstrated fast onset of response for both skin and joints with ACR20 response rates (RR) of 80% for the top 3 pooled doses compared to a response rate of 17% in the placebo group by Week 8. Additionally, findings showed a PASI90 RR of 87% for patients receiving the top three doses of bimekizumab versus 0% in the placebo group. Using a Bayesian statistical analysis, there was high posterior probability (>99%) that the ACR20 RR of bimekizumab at Week 8 was greater than those reported for current standard of care biologic treatments, including anti-IL-17A therapies. All doses of bimekizumab were well-tolerated. No treatment-related serious adverse events (AEs) were reported and there were no treatment-related discontinuations.