BRUSSELS and ATLANTA, Sept. 29, 2021 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new interim results from the BE BRIGHT open-label extension (OLE) study evaluating the long-term safety, tolerability and efficacy of bimekizumab through to two years in adult patients with moderate to severe plaque psoriasis who completed one of the three Phase 3 pivotal studies. These data, together with additional findings from the Phase 3/3b clinical program for bimekizumab in psoriasis, were presented today across nine UCB-supported abstracts at the 30th European Academy of Dermatology and Venereology (EADV) Congress.
"Following the recent approval of bimekizumab in Europe, we are pleased to share new two-year data at EADV supporting the clinical value of bimekizumab in the treatment of moderate to severe psoriasis. The range of longer-term efficacy and safety data presented offer important new insights for the dermatology community and reflect our commitment to improving the standard of care for people with psoriasis," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
Interim data from the BE BRIGHT study presented at EADV showed that patients treated with bimekizumab achieved sustained levels of skin clearance (PASI 90 and PASI 100) through to two years with continuous maintenance dosing, and that bimekizumab was generally well tolerated, with no new safety signals identified.1,2,3 Switching to bimekizumab following 24 weeks of adalimumab treatment (BE SURE) resulted in a sustained increase in PASI 90 and PASI 100 responder rates up to two years.1,4 In addition, switching to bimekizumab following 52 weeks of ustekinumab treatment (BE VIVID) resulted in a sustained increase in PASI 100 responder rates up to week 100.2,5 Patients switching to bimekizumab after an inadequate response to ustekinumab at week 52 also showed sustained improvements in levels of skin clearance (PASI 90 and PASI 100).2
"In clinical practice, patients with moderate to severe plaque psoriasis may need to transition between biologics to optimally control their disease. Longer-term results from the BE SURE study and the BE BRIGHT open-label extension study shared at EADV 2021 demonstrated that switching from adalimumab to bimekizumab helped more patients with moderate to severe psoriasis to achieve and maintain completely clear skin, as measured by PASI 100, through two years of treatment," said Professor Diamant Thaçi, Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lübeck, Lübeck, Germany.
Longer-term results from BE SURE and BE BRIGHT open-label extension trial¥
After completing the Phase 3 BE SURE trial, patients could enroll in the OLE study.1,4 In bimekizumab-randomized patients (320 mg every four weeks [Q4W] through two years), PASI 90 response rates were 91.2 percent at both weeks 16 and 104.1,4,5 PASI 100 response rates in this group were 61.6 percent at week 16 and 72.3 percent at week 104.1,4 In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through two years), the percentage of patients reaching PASI 90 was 89.4 percent at week 16 and 89.7 percent at week 104.1,4 Levels of PASI 100 response in this group were 62.8 percent at week 16 and 68.1 percent at week 104.1,4
Switching from adalimumab to bimekizumab 320 mg Q4W resulted in sustained response rates (PASI 90 and PASI 100) through to two years (week 104), which were comparable to the response rates seen in patients receiving continuous bimekizumab treatment.1 Bimekizumab was well tolerated over two years, with no new safety signals.1
Bimekizumab data up to two years in patients switching from ustekinumab±
This analysis included adult patients from BE VIVID who were initially randomized to ustekinumab 45 mg / 90 mg (by weight) at weeks 0 / four, then every 12 weeks, or bimekizumab 320 mg Q4W through week 52.2,5 Based on the PASI 90 response at week 52, patients entering the OLE were re-randomized to bimekizumab 320 mg Q4W or Q8W.2
At entry to the OLE study, 44.9 percent of ustekinumab-treated patients and 73.6 percent of bimekizumab-treated patients had achieved PASI 100.2, For all patients who switched from ustekinumab to bimekizumab the PASI 100 response increased to 65.4 percent at week 56, 78.7 percent at week 68 and 69.9 percent at week 100, which was comparable to the response rate seen in patients receiving continuous bimekizumab treatment at week 68 (75.4 percent) through week 100 (68.8 percent).2 For patients who switched to bimekizumab following an inadequate response to ustekinumab at week 52, high levels of response were achieved. At week 56, after one dose of bimekizumab, 77.3 percent of these patients achieved PASI 90 and 40.9 percent achieved PASI 100. These responses were sustained and further improved at week 100, with 84.1 percent and 54.5 percent of patients achieving PASI 90 and PASI 100, respectively. There were no unexpected safety findings in patients who switched from ustekinumab to bimekizumab during the OLE. 2
Pooled safety data from up to two years of treatment in Phase 2 and 3 clinical trials
Across Phase 2 and 3 trials, the total bimekizumab exposure was 3,109.7 patient-years (N=1789).3 Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 patient-years, serious TEAEs were seen at an EAIR of 5.9 new cases per 100 patient-years and TEAEs leading to discontinuation at 3.8 new cases per 100 patient-years.3 The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis (EAIR: 19.1 new cases per 100 patient-years), oral candidiasis (12.6 new cases per 100 patient-years) and upper respiratory tract infection (8.9 new cases per 100 patient-years).3 The EAIR for oral candidiasis showed a decrease compared with one year of bimekizumab treatment (12.6 new cases per 100 patient-years versus 16.4 new cases per 100 patient-years) and was lower with bimekizumab dosed Q8W (9.6 per 100 patient-years) compared with Q4W (16.4 per 100 patient-years).3 The majority of cases (98.5 percent of patients experiencing oral candidiasis) were mild or moderate and rarely led to study discontinuation.3
¥ Modified non-responder imputation analyses
±Non-responder imputation analyses
Bimekizumab is an investigational humanized IgG1 monoclonal antibody that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.4,5,7 Selective inhibition of IL-17F in addition to IL-17A has been shown to suppress inflammation to a greater extent than IL-17A inhibition alone.4,5,7
The efficacy and safety of bimekizumab have not been established. Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults.
About BE BRIGHT6
BE BRIGHT (NCT03598790) is an ongoing, multicenter, open-label extension study assessing the long-term safety, tolerability and efficacy of bimekizumab in adult patients with moderate to severe plaque psoriasis. Patients who completed one of three bimekizumab Phase 3 studies, BE READY, BE VIVID and BE SURE, were eligible to enroll in the BE BRIGHT study. More details can be found at ClinicalTrials.gov.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
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1 Thaçi D, Vender R, de Rie M, et al. Safety and efficacy of bimekizumab through 2 years in patients with moderate to severe plaque psoriasis: Longer-term results from the BE SURE randomised controlled trial and the BE BRIGHT open-label extension trial. Presented at EADV 2021.
2 Leonardi C, Sator PG, Morita A, et al. Bimekizumab efficacy and safety up to two years in patients with moderate to severe plaque psoriasis switching from ustekinumab: Interim results from the BE BRIGHT open-label extension trial. Presented at EADV 2021.
3 Reich K, Ståhle M, Okubo Y, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to two years of treatment in phase 2 and 3 clinical trials. Presented at EADV 2021.
4 Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
5 Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
6 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790?term=NCT03598790&draw=2&rank=1. Last accessed September 2021
7 Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.
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