The New England Journal of Medicine publishes results from two bimekizumab phase III studies in moderate to severe plaque psoriasis- UCB

UCB announced that The New England Journal of Medicine has published two manuscripts with results from BE RADIANT and BE SURE, two Phase III studies evaluating the efficacy and safety profile of bimekizumab, its investigational IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis. Results from the Phase IIIb BE RADIANT study were also shared as a late-breaking oral presentation at the American Academy of Dermatology Virtual Meeting Experience 2021. BE RADIANT is the first Phase III study to compare the efficacy and safety of dual IL-17A and IL-17F inhibition versus IL-17A inhibition alone. BE RADIANT RESULTS : The Phase IIIb BE RADIANT study compared the efficacy and safety of bimekizumab to secukinumab in adults with moderate to severe plaque psoriasis. The study met its primary endpoint, with significantly more patients treated with bimekizumab achieving complete skin clearance, as measured by a 100 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 100) at week 16, compared to those treated with secukinumab (61.7 percent versus 48.9 percent, respectively; p<0.001). the study also met all ranked secondary endpoints. the superior levels of complete skin clearance observed at week 16 continued through to week 48 with 67.0 percent of patients treated with bimekizumab achieving pasi 100 compared to 46.2 percent of patients treated with secukinumab p><0.001). at week 48 both bimekizumab maintenance dosing groups every four weeks q4w and every eight weeks q8w showed higher rates of complete skin clearance pasi 100 compared with secukinumab p><0.001). in addition at week 4 significantly more patients treated with bimekizumab achieved pasi 75 compared to patients treated with secukinumab 71.0 percent versus 47.3 percent respectively p><0.001). in be radiant patients treated with bimekizumab achieved superior levels of complete skin clearance pasi 100 compared with secukinumab-treated patients at week 16 the primary endpoint of the study and up to 48 weeks of therapy. at week 4 a faster onset of response was also observed with bimekizumab compared with secukinumab. data from this study support the value of inhibition of il-17f in addition to il-17a in the treatment of patients with moderate to severe plaque psoriasis. said prof. kristian reich m.d. ph.d. translational research in inflammatory skin diseases institute for health services research in dermatology and nursing university medical center hamburg-eppendorf germany. across the study duration the most common treatment-emergent adverse events teaes with bimekizumab were upper respiratory tract infections 38.9 percent oral candidiasis 19.3 percent and urinary tract infection 6.7 percent. oral candidiasis cases were predominantly mild or moderate and none led to discontinuation. over 48 weeks the incidence of serious teaes was 5.9 percent with bimekizumab and 5.7 percent with secukinumab. be sure results : the phase iii be sure study compared the efficacy and safety of bimekizumab to adalimumab in adults with moderate to severe plaque psoriasis. results from the be sure study were previously reported at the european academy of dermatology and venereology eadv congress 2020. be sure met its co-primary endpoints demonstrating that bimekizumab-treated patients achieved superior levels of skin clearance at week 16 compared to those who received adalimumab as measured by pasi 90 and investigators global assessment iga response of clear or almost clear skin iga 0 1 p><0.001 for both comparisons. these results were further supported by the study meeting all ranked secondary endpoints. the safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified. in september 2020 ucb announced that the fda and ema had accepted the companys biologics license application bla and marketing authorization application maa respectively for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults. ucb is committed to bringing bimekizumab to patients worldwide and additional regulatory filings are underway. see- reich k warren rb lebwohl m et al. bimekizumab versus secukinumab in plaque psoriasis.- nejm. available at: www.nejm.org doi full 10.1056 nejmoa2102383. see- warren rb blauvelt a bagel j et al. bimekizumab versus adalimumab in plaque psoriasis. nejm. available at: www.nejm.org doi full 10.1056 nejmoa2102388 .>