UCB announces late-breaking two-year data for BIMZELX[®]▼(bimekizumab) in moderate to severe hidradenitis suppurativa at EADV 2024

Brussels (Belgium), September 27, 2024 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced the first presentation of two-year data from the Phase 3 studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and safety of bimekizumab, an IL-17A and IL-17F inhibitor, in adults with moderate to severe hidradenitis suppurativa (HS).¹ These new data are presented today as a late-breaking platform presentation at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, 25–28 September 2024.

Results showed that the clinically meaningful improvements observed with bimekizumab treatment at one year were maintained over two years.^1* At Week 96, 85.4 percent (n=381/446) of patients treated with bimekizumab achieved HS Clinical Response 50 (HiSCR50). The more stringent endpoints, HiSCR75 and HiSCR100, were achieved by 77.1 percent (n=344/446) and 44.2 percent (n=197/446) of patients, respectively.^1* Improvements in the severity of disease, reductions in draining tunnel count and improvements in health-related quality of life were also maintained over two years.^1* Bimekizumab was generally well tolerated and no new safety signals were observed.¹

“Hidradenitis suppurativa is a chronic, relapsing and painful inflammatory skin disease that significantly impacts patients’ quality of life. The bimekizumab data presented at EADV 2024 showed maintained improvements in clinical response, symptoms, severity and quality of life over two years. These findings are particularly encouraging given the need for new treatment options that offer sustained relief for patients,” said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V., Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany. 

“In moderate to severe hidradenitis suppurativa, healthcare professionals and patients value long-term data when they are making treatment decisions. We are proud to present, for the first time, the bimekizumab two-year results at EADV 2024,” said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. “These longer-term data build on the 48-week results, demonstrating maintained response over two years, which is highly relevant for the hidradenitis suppurativa community.” 

Summary of the bimekizumab two-year data in moderate to severe HS presented at EADV 2024:    

Patients who completed Week 48 in BE HEARD I and BE HEARD II could enroll in the open-label extension study and received bimekizumab every two weeks (Q2W) or every four weeks (Q4W) based on ≥90 percent HiSCR averaged from Weeks 36, 40 and 44. Results are shared for the bimekizumab total patient group.

• HS Clinical Response: 
  • HiSCR50 was achieved by 79.9 percent (n=444/556) of bimekizumab patients at Week 48 and 85.4 percent (n=381/446) at Week 96.^1* 
  • HiSCR75 was achieved by 64.0 percent (n=356/556) of bimekizumab patients at Week 48 and 77.1 percent (n=344/446) at Week 96.^1* 
  • HiSCR90 was achieved by 42.3 percent (n=235/556) of bimekizumab patients at Week 48 and 57.6 percent (n=257/446) at Week 96.^1* 
  • HiSCR100 was achieved by 30.2 percent (n=168/556) of bimekizumab patients at Week 48 and 44.2 percent (n=197/446) at Week 96.^1* 
• International HS Severity Score System (IHS4): Patients treated with bimekizumab saw a decrease in the severity of their HS symptoms as measured by the IHS4 score.^1* The mean IHS4 score at baseline was 35.6±31.5 among bimekizumab patients.^1* The percent change from baseline in IHS4 score at Week 48 among bimekizumab patients was maintained through Week 96 (-70.3±39.6 and -79.8±28.1 at Week 48 and Week 96, respectively).^1* 
• Draining tunnel (DT) count: The mean DTs at baseline was 3.8±4.3 among bimekizumab patients.^1* The percent change from baseline in draining tunnel count at Week 48 among bimekizumab patients was maintained through Week 96 (–57.5 ±72.9 and –73.7±45.7 percent at Week 48 and Week 96, respectively).^1* 
• Health-related quality of life: The proportion of bimekizumab patients who achieved Dermatology Life Quality Index (DLQI) 0/1 at Week 48 was maintained through Week 96. The Mean DLQI Total at baseline was 11.0±6.8 among bimekizumab patients. Approximately one in three patients reported minimal or no impact of the disease on their health-related quality of life over two years (27.4 percent [n=151/155] and 33.9 percent [n=149/439] at Week 48 and Week 96, respectively).^1* 

Bimekizumab was generally well-tolerated over two years with no new safety signals observed. Over two years, 917/995 patients who received ≥1 dose of bimekizumab experienced a treatment-emergent adverse event (TEAE). Serious TEAEs were reported in 122 patients.¹ Over two years, the most common TEAEs (exposure adjusted incidence rates) were hidradenitis (20.5), coronavirus infection (15.3) and oral candidiasis (10.5).¹

Notes to Editors:   
* Observed Case  

About hidradenitis suppurativa

Hidradenitis suppurativa (HS) is a chronic, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.^2,3  The main symptoms are nodules, abscesses and pus-discharging draining tunnels (or sinus tracts 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 develops in early adulthood and affects approximately one percent of the population in most studied countries.^2,3

About BE HEARD I/BE HEARD II and the Open-Label Extension Study

The efficacy and safety profile of bimekizumab were evaluated in adult patients with moderate to severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).⁴ The two studies had a combined enrolment of 1,014 participants.⁴ In each study, patients were randomized 2:2:2:1 (initial [16-week]/maintenance [32-weeks]) to bimekizumab 320 mg every two weeks, four weeks or a combination (Q2W/Q2W, Q2W/Q4W, Q4W/Q4W or placebo/Q2W).1 Patients who completed Week 48 could enroll in the open-label extension.¹ Of 1,014 total patients, 556 patients randomized at baseline to bimekizumab in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96.¹ The primary endpoint in both trials was HiSCR50 at Week 16.⁴ A key secondary endpoint was HiSCR75 at Week 16.4 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 or draining tunnel count.⁴

About BIMZELX^®▼(bimekizumab) in the European Union/European Economic Area

The approved indications for bimekizumab▼ in the EU are:⁵

• 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.

The label information may differ in other countries where approved. Please check local Prescribing Information. 

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

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5 percent, 14.6 percent, 16.3 percent, 8.8 percent in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3 percent, 2.3 percent, 3.7 percent, 5.6 percent 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: August 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf 

Last accessed: September 2024.

▼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. 

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. Zouboulis C, Garg A, Sayed C, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT. Abstract at EADV 2024. Amsterdam, Netherlands.
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. 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. Lancet. 2024;403(10443):2504-19.
5. BIMZELX^® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Accessed on September 2024.