New Long-Term Complete Skin Clearance Data for Bimekizumab in Moderate to Severe Plaque Psoriasis Presented at the 2022 AAD Annual Meeting

March 26, 2022 |

14 min read

UCB, a global biopharmaceutical company, announced that it is presenting 11 abstracts on bimekizumab in the treatment of adults with moderate to severe plaque psoriasis at the 2022 American Academy of Dermatology Annual Meeting in Boston, Massachusetts, U.S., on March 25-29, including a late breaking oral platform presentation and 10 posters.

Eleven abstracts highlight new data on bimekizumab in the treatment of adults with moderate to severe plaque psoriasis
Pooled data from five Phase 3/3b trials showed that more than eight out of 10 patients who achieved complete skin clearance with bimekizumab at week 16, and entered open-label extension, maintained this response through two years
Data from the open-label extension period of the BE RADIANT study showed that achievement of complete skin clearance at week 48 was maintained through week 96 with continuous bimekizumab treatment and improved for patients who switched from secukinumab to bimekizumab

ATLANTA, March 26, 2022 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that it is presenting 11 abstracts on bimekizumab in the treatment of adults with moderate to severe plaque psoriasis at the 2022 American Academy of Dermatology (AAD) Annual Meeting in Boston, Massachusetts, U.S., on March 25-29, including a late breaking oral platform presentation and 10 posters. The platform presentation details new analysis of pooled data from five bimekizumab Phase 3/3b clinical trials, which showed that over 80 percent of patients who achieved complete skin clearance (PASI 100) at week 16 and entered the open-label extension (OLE) studies maintained this response through two years, and no new safety signals were identified.¹

Among the poster presentations, new data from the OLE period of the Phase 3b BE RADIANT study showed that clinical responses (PASI 100 and absolute PASI, PASI ≤2) achieved at week 48 were maintained through week 96 with continuous treatment with bimekizumab and improved for patients who switched from secukinumab to bimekizumab on entry to the OLE.^2,3Patients who were PASI 90 non-responders with secukinumab at week 48 achieved improved clinical responses (PASI 90 and PASI 100) after switching to bimekizumab in the OLE.³ Among patients who were PASI 90 responders with secukinumab at week 48, PASI 90 response was maintained and PASI 100 response increased following switch to bimekizumab in the OLE.³

Bimekizumab is an investigational product and is not approved by the U.S. Food and Drug Administration (FDA). The safety and efficacy and safety have not been established. In the European Union and Great Britain, bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.^4,5

“Long-term complete skin clearance is an important goal for people with psoriasis, and the new 96-week data from the open-label extension period of the BE RADIANT study offer fresh insights on the sustained response and clinical potential of bimekizumab in moderate to severe plaque psoriasis,” said Bruce Strober, M.D., Ph.D., Clinical Professor, Department of Dermatology, Yale University School of Medicine, New Haven, CT, U.S., and Central Connecticut Dermatology Research, Cromwell, CT, U.S. “In addition, the improved clinical responses seen in patients who switched to bimekizumab after 48 weeks of treatment with secukinumab offer further new insights that should help to inform future clinical practice.”

Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB, said: “We are pleased to share our latest long-term data on bimekizumab with the dermatology community at the 2022 AAD Annual Meeting. The wealth of new data, insights and progress being presented underlines our commitment to advances in psoriasis care for people living with this challenging, life-long condition.”

Phase 3/3b studies: two-year pooled data for bimekizumab in patients with moderate to severe plaque psoriasis¹¥
Data were pooled from the BE VIVID, BE READY, and BE SURE Phase 3 trials, the Phase 3b BE RADIANT trial and OLE (48 weeks), and the first year of the BE BRIGHT OLE study. Analysis evaluated PASI 100 maintenance through two years (OLE 48 weeks) among PASI 100 week 16 responders who entered the respective OLE studies and received continuous bimekizumab maintenance dosing from week 16 (320 mg every four weeks [Q4W/Q4W/Q4W] or Q4W/Q8W/Q8W). At week 16, 62.4 percent of bimekizumab-treated patients (n=1,362) achieved PASI 100. Of those who entered the OLEs, 85.1 percent (Q4W/Q4W/Q4W; n=316) and 83.8 percent (Q4W/Q8W/Q8W; n=267) maintained PASI 100 at year two (OLE week 48). The exposure-adjusted incidence rates (EAIRs) of overall and serious treatment emergent adverse events (TEAEs) were 192.7 and 5.9. The most common TEAEs were nasopharyngitis (EAIR of 18.4), oral candidiasis (13.0), and upper respiratory tract infections (7.8). Almost all cases of oral candidiasis (98.1 percent) were mild or moderate.

BE RADIANT open-label extension study in patients with moderate to severe plaque psoriasis: efficacy and safety data through 96 weeks²
Complete skin clearance (PASI 100) levels observed with bimekizumab in the BE RADIANT study were maintained in the OLE through week 96 (74.8 percent and 70.6 percent at weeks 48 and 96, respectively) and improved for patients who switched from secukinumab to bimekizumab on entry to the OLE period at week 48 (52.8 percent and 76.1 percent at weeks 48 and 96, respectively). The absolute PASI response (PASI ≤ 2) was also maintained through week 96 (94.3 percent and 93.4 percent at weeks 48 and 96, respectively) and improved for patients who switched from secukinumab to bimekizumab on entry to the OLE period (83.9 percent and 94.6 percent at weeks 48 and 96, respectively). During the OLE, the most common adverse events with bimekizumab were nasopharyngitis (11.8/100 patient-years), oral candidiasis (7.8/100 patient-years), and urinary tract infection (4.5/100 patient-years). Adverse events were comparable between patients continuing bimekizumab or switching from secukinumab to bimekizumab. The incidence of serious adverse events was low. These analyses included 336 patients treated with bimekizumab, and 318 patients treated with secukinumab who completed the BE RADIANT double-blinded period and switched to bimekizumab upon entering the OLE.

BE RADIANT open-label extension study in patients with moderate to severe plaque psoriasis: responder analysis in patients switching from secukinumab to bimekizumab³
At week 48, 53/318 patients (16.7 percent) treated with secukinumab had not achieved PASI 90. After switching to bimekizumab in the OLE, responses improved. At week 96, 79.2 percent of this group achieved PASI 90, and 50.9 percent achieved PASI 100. At week 48, 256/318 patients (80.5 percent) treated with secukinumab had achieved PASI 90. After switching to bimekizumab in the OLE, 95.2 percent of this group maintained this response at week 96, and the PASI 100 response increased from 65.2 percent at week 48 to 79.9 percent at week 96. No clinically relevant differences in safety outcomes for patients who switched from secukinumab to bimekizumab were observed from weeks 48-96.

¥ Modified non-responder imputation analyses

About the BE READY, BE VIVID and BE SURE studies and the BE BRIGHT open-label extension study^6,7,8,9
The efficacy and safety of bimekizumab in the treatment of adults with moderate to severe plaque psoriasis were evaluated in three Phase 3 studies, versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), and versus adalimumab (BE SURE). Patients who completed one of these three Phase 3 studies were eligible to enroll in the BE BRIGHT open-label extension study.

About the BE RADIANT and BE RADIANT open-label extension study¹⁰
BE RADIANT was a Phase 3b, randomized, multicenter, double-blind, active-comparator-controlled, parallel-group study designed to assess the efficacy and safety of bimekizumab compared to secukinumab in adults with moderate to severe chronic plaque psoriasis. Patients who completed the 48-week double-blinded period were able to enroll in the ongoing 96-week open-label extension, where they all received bimekizumab.

About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively and directly inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes^.11

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, and its efficacy and safety have not been established for any indication in the U.S.

For further information, contact UCB:

Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com

Corporate Communications
Ally Funk
T +1.678.365.6321
email ally.funk@ucb.com

Brand Communications
Eimear O’Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com

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 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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References

Gordon KB, Armstrong A, Lebwohl M, et al. Bimekizumab efficacy and safety through two years in patients with moderate to severe plaque psoriasis: Analysis of pooled data from five phase 3/3b clinical trials. To be presented at the 2022 AAD Annual Meeting.
Strober B, Paul C, Blauvelt A, et al. Bimekizumab efficacy and safety through 96 weeks in patients with moderate to severe plaque psoriasis: Results from the open-label extension period of the BE RADIANT phase 3b trial. To be presented at the 2022 AAD Annual Meeting.
Lebwohl M, Ghoreschi K, Strober B, et al. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis who switched from secukinumab: Results from the open-label extension period of the BE RADIANT phase 3b trial. To be presented at the 2022 AAD Annual Meeting.
BIMZELX (bimekizumab) EU Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed March 2022.
BIMZELX (bimekizumab) GB Summary of Product Characteristics https://www.medicines.org.uk/emc/product/12834;
https://www.medicines.org.uk/emc/product/12833. Last accessed: March 2022.
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.
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.
Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
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: March 2022.
Reich K, Warren R, Lebwohl M, et al. Bimekizumab versus Secukinumab in Plaque Psoriasis N Engl J Med. 2021;385(2):142-152.
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.