UCB announces publication in The Lancet of phase 3 bimekizumab▼ trials in moderate to severe hidradenitis suppurativa

Brussels (Belgium), 23 May, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that The Lancet has published results from the Phase 3 BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of bimekizumab, an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).¹ This article represents the primary publication of bimekizumab data from the two pivotal Phase 3 HS studies. HS is one of the most burdensome, chronic, systemic, inflammatory skin diseases that can have a profound impact on patients’ health-related quality of life.^2,3,4

“Publication of results from the BE HEARD I and II trials in The Lancet, a world-leading medical journal, reflects the significance of these data to the dermatology community. People living with hidradenitis suppurativa face high unmet medical needs. The positive results from these trials support global regulatory submissions for bimekizumab in this chronic inflammatory skin disease,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. 

“The Phase 3 studies with bimekizumab represent a significant milestone for the hidradenitis suppurativa community, and they include HiSCR75, a high threshold endpoint, as a key ranked secondary outcome. In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease. These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future,” said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S.

In April 2024, UCB announced that the European Commission granted marketing authorization for bimekizumab for the treatment of active moderate to severe HS in adults with an inadequate response to conventional systemic HS therapy. In April 2024, UCB also announced that the U.S. Food and Drug Administration accepted for review the supplemental biologics license application for bimekizumab-bkzx for the treatment of adults with moderate to severe HS. Other regulatory submissions for bimekizumab in the treatment of moderate to severe hidradenitis suppurativa are underway around the world. 

Notes to editors:

About BE HEARD I and BE HEARD II

BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 3 trials designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS).¹ The two trials had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS.1 The primary endpoint in both trials was HiSCR50 at Week 16.¹ A key secondary endpoint was HiSCR75 at Week 16.¹ HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess and inflammatory nodule count or draining tunnel count.¹

Results from BE HEARD I and BE HEARD II showed that a significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16.  Responses were maintained to Week 48.¹ The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.¹ 

About hidradenitis suppurativa (HS) 

Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease, that is associated with systemic manifestations.^2,3 The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin) which typically occur in the armpits, groin, and buttocks.^2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^2,3 HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.^2,3 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.2,3 The symptoms of pain, discharge and scarring are not only a physical burden. People with HS also experience stigma: worrying about, or directly experiencing, negative attitudes and reactions from society in response to their symptoms.⁴ These feelings can lead to embarrassment, social isolation, low self-esteem and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.⁵  

About bimekizumab

BIMZELX^® (bimekizumab) is a humanized monoclonal IgG1 antibody designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.⁶

The therapeutic indications in the EU are⁷: 

• Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 
• Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 
• Axial Spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP), and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. 
• Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.

BIMZELX^® ▼ (bimekizumab) EU/EEA* Important Safety Information⁷

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.
Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.
Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information.

European SmPC date of revision: April 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf    

*EU/EEA means European Union/European Economic Area

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Last accessed: May 2024.

For further information, contact UCB: 

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

Corporate Communications
Laurent Schots 
T +32.2.559.92.64 
email laurent.schots@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 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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References

1. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double blind, placebo controlled, multicentre phase 3 trials The Lancet. Published Online May 22, 2024. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00101-6/fulltext
2. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64.
3. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
4. Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12(1):785–90.
5. Kokolakis G, Wolk K, Schneider-Barrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–30.
6. 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.
7. BIMZELX® (bimekizumab) EU Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: May 2024.