Milan, May 5 (beraking latest news Salute) – Two clinical phase 3 studies published in ‘Nejm’ demonstrate the safety and efficacy profile of the monoclonal antibody bimekizumab, an investigational inhibitor of interleukins IL-17A and IL-17F for the treatment of adult patients with psoriasis moderate to severe plaque.
“The publication of data from the Be Radiant and Be Sure studies in ‘The New England Journal of Medicine’ underlines the relevance of these trials for the medical-scientific community and shortly follows the publication, this same year, of the first two studies. Phase 3 on bimekizumab in ‘The Lancet’ – says Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US of the biopharmaceutical company Ucb – The results published today show the high rates of complete ‘skin clearance’, Pasi 100, per week 16, the rapid response after a single dose administered and the durability of the response, up to one year, as seen in previous studies of bimekizumab “.
Be Radiant is the first phase 3 trial to compare the efficacy and safety of the combined inhibition of IL-17A and IL-17F with the inhibition of IL-17A1 alone, explains in a Ucb note that illustrated the results of the study. on 23 April with an oral presentation during the American Academy of Dermatology Virtual Meeting Experience 2021. At the event, which took place from 23 to 25 April, the company brought 12 abstracts (the oral presentation and 11 posters) related to bimekizumab. “The breadth of the data presented – says Caeymaex – reinforces our commitment to advance research and science in the field of psoriasis. It is a privilege to share these results and we look forward to engaging with the dermatology community to address the unmet needs of people with psoriasis “.
The Phase 3b Be Radiant study – details Ucb – compared the efficacy and safety of bimekizumab versus secukinumab in adults with moderate to severe plaque psoriasis. “Patients treated with bimekizumab – summarizes Kristian Reich, Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany – achieved 16 higher levels of complete skin clearance per week, Pasi 100, compared to patients treated with secukinumab, the primary endpoint of the study “which, however, also met all secondary endpoints:” The data was confirmed up to week 48 of therapy. At week 4 a faster response with bimekizumab was also observed compared to secukinumab “.
The most common side effects (Treatment-emergent adverse event, Teae) recorded among those treated with bimekizumab were upper respiratory tract infections (38.9%), oral candidiasis (19.3%) and urinary tract infections (6, 7%). The cases of oral candidiasis – the note reads – were predominantly mild or moderate and none led to the suspension of treatment. Over 48 weeks, the incidence of severe Teae was 5.9% with bimekizumab and 5.7% with secukinumab.
The phase 3 study Be Sure, the results of which were presented at the European Academy of Dermatology and Venereology congress in 2020, compared the efficacy and safety of bimekizumab versus adalimumab in adults with moderate to plaque psoriasis. serious. The data show that patients treated with bimekizumab achieve skin clearance levels higher than those treated with adalimumab, according to the values of the parameters Pasi 90 and Investigator’s Global Assessment. These results were later confirmed by the achievement of all secondary endpoints. The safety profile of bimekizumab was consistent with previous clinical studies and there were no new safety reports. In September 2020 Ucb announced that the American FDA and the European EMA have accepted the Biologics License Application (Bla) and the Marketing Authorization Application (Maa) respectively for bimekizumab for the treatment of moderate to severe plaque psoriasis in adult patients. .