• Symptom relief sustained to three years: Improvements in the stringent endpoints HiSCR75, HiSCR90, and HiSCR100 at one year were sustained to three years in 81.2%, 64.3%, and 50.1% of patients, respectively*     
• Resolution of inflammatory lesions: Of patients who achieved IHS4-100 (European clinical metric to assess the severity of HS1) at year one, 64.3% achieved and maintained this complete resolution of inflammatory lesions through to two years*    
• Impact of earlier treatment: Across the high-efficacy IHS4 threshold, patients treated earlier in their moderate-to-severe HS with BIMZELX® (bimekizumab-bkzx) had improved outcomes at two years*
• Dual inhibition: BIMZELX^® (bimekizumab-bkzx) is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A)² 
   

Atlanta, September 17, 2025 – 7:00 A.M. (ET) – UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),2 continued to be generally well tolerated, and demonstrated sustained symptom relief.3-9

“A crucial goal for treating people with hidradenitis suppurativa is achieving and maintaining long-term disease control at the most stringent levels,” said John Ingram, Professor of Dermatology, Cardiff University. “These data for bimekizumab – including HiSCR100 and IHS4-100 – showed symptom relief can be maintained long-term.”

Among patients with HS, improvements in HiSCR50/75/90/100 seen at one year were sustained to three years in 90.2% (331/367), 81.2% (298/367), 64.3% (236/367), and 50.1% (184/367) of patients, respectively^.3* Improvements in quality of life, as measured by DLQI 0/1, seen at year one in 27.4% (151/551) of patients were sustained to three years, with 38.1% (137/360) of patients reporting no effect of skin disease on their quality of life.^3* Patients who achieved IHS4-55/75/90/100 at Week 48 maintained this response to two years in 90.8% (315/347), 85.1% (235/276), 71.2% (136/191) and 64.3% (74/115) of cases, respectively.^4* Patients with shorter disease duration since HS diagnosis had better outcomes than those with longer disease duration, particularly at higher efficacy thresholds, emphasizing the potential impact of earlier treatment with BIMZELX upon diagnosis of moderate-to-severe HS^.5* At Week 96, proportions of patients in the lowest disease duration quartile (<2.38 years [n=115]) achieving IHS4-55/75/90/100 were 88.7% (n=102), 73.9% (n=85), 59.1% (n=68), and 46.1% (n=53), respectively.^5* Similarly, IHS4-55/75/90/100 responses in the highest disease duration quartile (≥10.74 years [n=101]) at Week 96 were 77.2% (n=78), 62.4% (n=63), 39.6% (n=40) and 22.8% (n=23), respectively.^5* Over two years, at the patient level, BIMZELX treatment reduced the number of draining tunnels in the majority of individuals.^6* In addition, over two years of treatment with BIMZELX, a greater reduction in skin pain severity translated into an improvement in health-related quality of life for people living with HS.^7*

“The three-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as long-term improvements in health-related quality of life for people living with hidradenitis suppurativa,” said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB. “Long-term efficacy and safety data are vital for advancing understanding of chronic inflammatory conditions like hidradenitis suppurativa, and these findings underscore UCB’s commitment to advancing science-led insights and providing transformative treatment options to improve outcomes for patients.”

Treatment with BIMZELX was generally well tolerated, with no new safety signals observed up to three years.^3* The safety profile up to three years was consistent with years one and two.^3* 

UCB’s data on BIMZELX in HS will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, September 17-20. The abstracts are part of the 19 other presentations from UCB across BIMZELX in psoriasis, psoriatic arthritis, axial spondyloarthritis, as well as the abstract for the investigational therapy galvokimig in atopic dermatitis.^† 

*OC: Data are reported as observed case (OC). The data reported are from an open-label study. Patients completing the 48-week BE HEARD I & II studies could enroll in BE HEARD EXT and receive open-label BIMZELX (BKZ) 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40, and 44. Data are reported for patients randomized to BKZ from baseline in BE HEARD I & II who entered BE HEARD EXT (BKZ Total group, n=556) at Week 48. Only patients who entered the third year are included.3-6

†Galvokimig is currently under clinical investigation and is not approved by any regulatory authority worldwide.

Notes to Editors:
 

• HiSCR50/HiSCR75/HiSCR90/HiSCR100: These are defined as at least a 50%/75%/90%/100% reduction in the total abscess and inflammatory nodule count from baseline with no increase from baseline in abscess or draining tunnel count.10,14

• IHS4‑55/75/90/100: IHS4 is the clinician-rated International HS Severity Score System (IHS4), which evaluates the number of inflammatory nodules/abscesses/draining tunnels. IHS4‑55/75/90/100 is defined as at least a 55%/75%/90%/100% improvement from baseline in a patient’s IHS4 total score. IHS4-100 equates to complete resolution of inflammatory lesions.5

• Draining tunnels: These are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring.11-12

• DLQI 0/1: Dermatology Life Quality Index (DLQI) is a patient-reported questionnaire consisting of 10 questions concerning symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.13 Each question is scored from 0 to 3 and the scores summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment).13 All questions relate “to the last week.” The DLQI was designed to be used in adults over the age of 18 years.13 DLQI 0/1 denotes patients who achieved an overall score of 0 or 1 in the questionnaire, and denotes no effect at all on a patient’s quality of life.13

• Results included patients receiving both Q2W and Q4W after Week 48. All patients who continued in the trial after Week 48 were subsequently switched to Q4W by the end of year three. For safety outcomes, data are reported for patients who received one or more dose of BKZ across BE HEARD I & II and BE HEARD EXT (total of three years). The FDA approved dose of BIMZELX for adult patients with moderate-to-severe hidradenitis suppurativa is 320mg Q2W to Week 16, followed by Q4W. 

• The most common treatment emergent adverse events (TEAEs) rates were hidradenitis (19.6/100 patient years [PY]), coronavirus infection (14.1/100 PY), and oral candidiasis (9.3/100 PY).3*
   

About hidradenitis suppurativa
Hidradenitis suppurativa (HS) is a chronic, painful, and potentially debilitating inflammatory skin disease that is associated with systemic manifestations.11-12 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.11-12 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.11-12 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.11-12

About BE HEARD trials
The efficacy and safety profiles of BIMZELX 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).14 The two studies had a combined enrollment of 1,014 participants.14 In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) to BIMZELX 320 mg every two weeks, four weeks, or a combination (BKZ Q2W/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W or placebo/BKZ Q2W).14

Patients who completed Week 48 could enroll in the open-label extension.15 Of 1,014 total patients, 556 patients randomized at baseline to BIMZELX 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 96,11 and 367 completed to Week 148.3

For details about BE HEARD EXT: www.clinicaltrials.gov/study/NCT04901195.

About BIMZELX^® (bimekizumab-bkzx)
BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes^.2 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.^2,16-18 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).^2,16-19

The approved indications for BIMZELX in the U.S. are:²

• Plaque psoriasis: BIMZELX is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
• Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
• Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
• Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
• Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa

BIMZELX U.S. IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior
BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.

Infections
BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.

Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.

Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.  

Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.  

Most Common Adverse Reactions 
Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.

Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection.

Please see full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX.

For further information, contact UCB:

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

Brand Communications
Nicole Herga 
T +1.773.960.5349 
email: nicole.herga@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 €6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on X: @UCBUSA.

Forward looking statements 
This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. 

Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.
UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.


References 
 

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   Results from the phase 3 BE HEARD I&II trials and their open-label extension BE HEARD EXT. Oral D1T01.2E.
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    multicentre phase 3 trials. Lancet. 2024;403(10443):2504–19.
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    suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT [abstract]. Skin. 
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