The New England Journal of Medicine Publishes Results from Two Bimekizumab Phase 3 Studies in Moderate to Severe Plaque Psoriasis

BRUSSELS, April 23, 2021 /PRNewswire/ -- UCB, a global biopharmaceutical company, announced today that The New England Journal of Medicine has published two manuscripts with results from BE RADIANT and BE SURE, two Phase 3 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.^1,2 Results from the Phase 3b BE RADIANT study were also shared today as a late-breaking oral presentation at the American Academy of Dermatology Virtual Meeting Experience 2021.³ BE RADIANT is the first Phase 3 study to compare the efficacy and safety of dual IL-17A and IL-17F inhibition versus IL-17A inhibition alone.¹

“The publication of data from BE RADIANT and BE SURE in The New England Journal of Medicine underscores the significance of these studies to the medical community, and closely follows the publication of the first two bimekizumab Phase 3 studies in The Lancet earlier this year,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “Results published today reflect the high rates of complete skin clearance, PASI 100, at week 16, rapid response after one dose and durability of response up to one year seen with bimekizumab in previous studies.”

The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.

BE RADIANT RESULTS
The Phase 3b BE RADIANT study compared the efficacy and safety of bimekizumab to secukinumab in adults with moderate to severe plaque psoriasis.¹ 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).¹

The study also met all ranked secondary endpoints.¹ 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).¹ 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).¹ 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).¹

“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).¹ Oral candidiasis cases were predominantly mild or moderate and none led to discontinuation.¹ Over 48 weeks, the incidence of serious TEAEs was 5.9 percent with bimekizumab and 5.7 percent with secukinumab.¹

BE SURE RESULTS
The Phase 3 BE SURE study compared the efficacy and safety of bimekizumab to adalimumab in adults with moderate to severe plaque psoriasis.² Results from the BE SURE study were previously reported at the European Academy of Dermatology and Venereology (EADV) Congress 2020.⁴

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 Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p<0.001 for both comparisons.² These results were further supported by the study meeting all ranked secondary endpoints.² The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified.^5,6,7,8

In September 2020, UCB announced that the FDA and EMA had accepted the Company’s 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.

*Upper respiratory tract infections include laryngitis, nasopharyngitis, pharyngeal abscess, pharyngitis, rhinitis, sinusitis, tonsilitis and upper respiratory tract infection.

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.⁹ IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.^{10,11,12,13,14} Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.^13,14 The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.

About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. This skin condition affects men and women of all ages and ethnicities.¹⁵ Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.¹⁶

Approximately 125 million people worldwide are living with psoriasis, nearly three percent of the world’s population.^17,18 Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately 30 percent of psoriasis patients reported that their primary goals of therapy, including keeping symptoms under control, reducing itching and decreasing flaking, were not met with their current treatment.¹⁹ Psoriasis has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.²⁰

About the BE RADIANT study¹
BE RADIANT is a Phase 3b, randomized, multicenter, double-blind, active comparator-controlled, parallelgroup study designed to assess the efficacy and safety of bimekizumab compared to secukinumab in adult subjects with moderate to severe chronic plaque psoriasis. BE RADIANT enrolled 743 participants with psoriasis for at least six months prior to the screening, a baseline PASI score ≥12, body surface area [BSA] affected by psoriasis ≥10% and IGA score ≥3.

Patients were randomized to bimekizumab (320 mg every Q4W) or secukinumab (300 mg weekly to week 4 and then Q4W).³ From week 16, bimekizumab-randomized patients received treatment dosed Q4W or every 8 weeks (Q8W). The primary endpoint was PASI 100 response at week 16. Key secondary endpoints included PASI 100 at week 48 and PASI 75 at week 4.¹ Following the 48-week double-blinded period, patients were able to enroll in an ongoing 96-week open-label extension.

UCB announced top-line findings from BE RADIANT in July 2020.

About the BE SURE study²
BE SURE was a Phase 3, randomized, double-blind study comparing the efficacy and safety of bimekizumab to adalimumab in adult patients with moderate-to-severe chronic plaque psoriasis. The active-controlled initial treatment period of 24 weeks was followed by a dose-blind maintenance treatment period until week 56.

BE SURE enrolled 478 participants with chronic plaque psoriasis for at least six months prior to screening and with an affected body surface area of ≥10 percent, PASI of ≥12 and IGA score ≥three on a five-point scale. The co-primary endpoints of the study were PASI 90 response and IGA response at week 16.

About UCB
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: @UCB_news.

Forward looking statements UCB
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References:

¹ 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 ² 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

³ Reich K, Warren RB, Lebwohl M, et al. Bimekizumab efficacy and safety versus secukinumab in patients with moderate to severe plaque psoriasis: Results from a multicenter, randomized, double-blinded, active comparator-controlled phase 3b trial (BE RADIANT). Latebreaking Presentation at AAD VMX 2021, April 23-25.

⁴ Warren R, et al. Bimekizumab efficacy and safety versus adalimumab in patients with moderate to severe plaque psoriasis: Results from a multicentre, randomised, double-blinded active comparator-controlled phase 3 trial (BE SURE). Abstract presented at EADV 2020, 29-31 October.

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. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00125-2/fulltext

⁶ 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. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00126-4/fulltext

⁷ Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10.

⁸ Blauvelt A, Merola JF, Papp KA, et al. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020;83(5):1367-1374.

⁹ Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.

¹⁰ Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.

¹¹ Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fold: structure and activity of a novel cytokine, IL-17F, and implications for receptor binding. EMBO J. 2001;20(19):5332–5341.

¹² van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. 2014;16(4):426.

¹³ Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.

¹⁴ Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.

¹⁵ National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/. Last accessed: March 2021.

¹⁶ International Federation of Psoriasis Associations. Available at: www.ifpa-pso.com/our-cause//. Last accessed: March 2021.

¹⁷ Griffiths C, van der Walt J, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4– e7.

¹⁸ World Health Organization. Global report on psoriasis, 2016. Available at: http://apps.who.int/iris/handle/10665/204417. Last accessed: March 2021.

¹⁹ Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87-97.

²⁰ Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.

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