UCB announces new data at EADV 2026 supporting earlier use of BIMZELX[®] (bimekizumab) for treating hidradenitis suppurativa

Brussels (Belgium), September 30, 2026 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced data for bimekizumab in moderate to severe hidradenitis suppurativa (HS) demonstrating substantial improvements with earlier treatment and improvements in draining tunnels in biologic-naïve patients to three years,^1,2,3,4 and improvements in total tunnels at one year.⁵ These data are being presented as part of UCB’s nine HS-focused abstracts at the European Academy of Dermatology and Venereology (EADV) 2026 Congress in Vienna, Austria, 30 September to 3 October.

“Active inflammatory tunnels in HS are often associated with considerable pain, impact on quality of life and irreversible structural damage,” said Professor Amit Garg, Founding Chair Department of Dermatology, Zucker School of Medicine, Hofstra/Northwell, New York, US. “The new data for bimekizumab at EADV show not only a greater impact on draining tunnels when used earlier, but also provide the first evidence of a HS treatment reducing the number of total tunnels – suggesting a potential impact of bimekizumab on HS disease progression.”

Bimekizumab is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). IL-17F and IL-17A are highly expressed in patients with HS, with IL-17F more abundant in HS serum and lesional skin than IL-17A.^6,7 IL-17F expression is significantly upregulated in lesions, with the highest expression in draining tunnels.⁸ DTs are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring and long-term structural damage, that have a profound impact on quality of life and daily living.^1,2,3,4,5

Additional long-term, three-year data presented at EADV showed treatment with bimekizumab in people living with moderate to severe HS was associated with sustained improvements in quality of life: high proportions of patients receiving bimekizumab achieved improvements in stringent quality of life measures, as assessed by DLQI and HiSQOL, sustained to three years.³* Further three-year data show bimekizumab was generally well tolerated, with no new safety signals observed, and no increased risks identified with longer bimekizumab exposure, up to three years.⁴*

The data in HS form part of UCB's broader presence at EADV 2026, with a total of 23 abstracts presented across its portfolio, underscoring UCB's commitment to advancing immunology through scientific innovation to improve outcomes for people living with immune-mediated diseases. This includes one abstract on galvokimig in atopic dermatitis,^† 21 abstracts on bimekizumab across HS, psoriasis, psoriatic arthritis and axial spondyloarthritis, and one abstract on unmet needs of patients in HS, showing the substantial disease burden and long pre-diagnostic interval that may contribute to disease progression and psychological impact in this disease.

“Our data for bimekizumab at EADV reinforce our commitment to revolutionizing science and redefining care in HS, supporting a future where earlier intervention helps prevent disease progression, transforms outcomes and improves quality of life for people living with this chronic condition,” said Donatello Crocetta, Chief Medical Officer, UCB. “These long-term three-year findings in HS, together with the broader body of data presented for bimekizumab across indications and galvokimig in atopic dermatitis, reflect our commitment to advancing dermatology through differentiated science and evidence generation.”

*OC: Data are reported as observed case (OC). Patients completing the 48-week BE HEARD I & II studies could enroll in BE HEARD EXT and receive open-label bimekizumab (BKZ) 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40, and 44.⁹ Patients receiving BKZ 320 mg Q4W in BE HEARD EXT who could not sustain an average improvement from baseline in AN count of >90% over any 8-week period or achieve >75% improvement from baseline in AN count at any single visit, could have their dose increased to Q2W at investigator discretion. Following approval of a protocol amendment in the third year, all BE HEARD EXT patients received BKZ Q4W. Data based on patients randomized to BKZ from baseline in BE HEARD I & II who completed BE HEARD EXT to Week 148 (BKZ Total group, N=367).^1,2,3,4,5 The approved dosing regimen for moderate to severe HS is bimekizumab 320 mg by subcutaneous injection Q2W up to Week 16 and then 320 mg Q4W thereafter.^10,11

†Galvokimig is currently under clinical investigation for the treatment of atopic dermatitis, chronic obstructive pulmonary disease (COPD) and non-cystic fibrosis bronchiectasis (NCFB). Galvokimig is not approved by any regulatory authority worldwide.

Substantial improvements in inflammatory lesions with earlier bimekizumab treatment

Impact of disease duration since diagnosis on inflammatory lesions through to three years was assessed in people with moderate to severe HS.¹ Outcomes included IHS4 responses by lowest (<2.38 years) and highest (≥10.74 years) baseline disease duration over three years.¹*At three years, proportions of patients in the lowest disease duration quartile (n=97) achieving IHS4-55/75/90/100 responses were to 89.7%, 79.4%, 62.9% and 47.4%, respectively.¹* IHS4-55/75/90/100 responses in the highest disease duration quartile (n=81) at three years were 91.4%, 70.4%, 53.1% and 33.3%, respectively.¹* This data is from a post-hoc analysis of the BE HEARD trials.¹

Improved draining tunnel outcomes in biologic-naïve patients

Of those who participated in the BE HEARD I&II trials, 556 patients completed Year 1 and entered BE HEARD EXT (BKZ Total group).² Among biologic-naïve patients, mean DT count decreased from 3.3 at baseline to 0.8 at three years, versus a decrease from a mean of 5.6 DTs at baseline to 1.3 for biologic-experienced patients.² The proportion of patients with 1–2, 3–5 and >5 DTs at baseline, respectively, achieving complete resolution of draining tunnels (DT=0) at one year was 66.7%, 50.8% and 36.8% of biologic-naïve patients; and 50.0%, 37.0% and 14.3% of biologic-experienced patients.²* At three years, these proportions were 78.8%, 69.1% and 48.3% of biologic-naïve patients; and 80.0%, 42.1% and 35.5% of biologic-experienced patients.²* This data is from a post-hoc analysis of the BE HEARD trials.²

Improvements beyond draining tunnels to all active tunnels

Total tunnels (TTs) were defined as the total number of all tunnels, whether actively draining or non-draining.⁵ Proportions of all patients achieving a TT or DT count of zero (TT=0 or DT=0, respectively) at one year are reported.⁵ The average proportion of tunnels that were draining (DTs/TTs) is reported for all patients.⁵ At baseline, of 868 patients in the BKZ Total group, 14.5% were TT=0 and 27.0% were DT=0.⁵ A total of 613 patients completed Year 1 in the BKZ Total group, of which 30.7% achieved TT=0 and 56.6% achieved DT=0.⁵ At Week 16, 37.3% of TTs were DTs in the BKZ Total group, and this proportion decreased to 31.3% at one year.⁵ This data is from a post-hoc analysis of the BE HEARD trials.⁵

Sustained improvements in quality of life

Health-related quality of life (HRQoL) outcomes were reported to three years, as determined by the Dermatology Life Quality Index (DLQI) total score and the proportions of patients achieving DLQI scores of 0/1 (no impact) and 0–5 (no/small impact).³ HS Quality of Life (HiSQOL) response rates and HiSQOL total score change from baseline were also utilized to measure HRQoL.³ HS symptoms, assessed through three years using the HS Symptom Questionnaire (HSSQ), showed improvements from one year, maintained at three years, in skin pain, itch, smell or odour and drainage or oozing symptoms, demonstrating disease control and reduced cumulative disease burden with bimekizumab treatment.³ The mean DLQI total score decreased from 11.0 at baseline to 4.5 at three years.³* The proportions of patients achieving DLQI 0/1 and DLQI 0–5 at three years was 38.1% and 71.7%, respectively.³* The proportion of patients reporting a HiSQOL total score of ≤14 at baseline was 24.1% and increased to 76.4% at three years.³* HSSQ skin pain, itch, smell or odour and drainage or oozing mean scores at baseline were 5.8, 4.9, 4.6 and 5.1, indicative of moderate to severe symptoms; this decreased to 2.0, 2.4, 2.1 and 2.1 at three years, indicative of milder symptom severity.³* This data is from a post-hoc analysis of the BE HEARD trials.³

Three-year safety data

Across BE HEARD I&II and BE HEARD EXT, 995 patients received ≥1 bimekizumab dose over three years and were included in this analysis.⁴ Over three years of bimekizumab exposure, totaling 2,118.6 PY, the EAIR for any TEAE was 243.3 per 100 PY.⁴* The most common TEAEs were hidradenitis, corona virus infections and oral candidiasis, with incidence rates of 19.6, 14.1 and 9.3 per 100 PY, respectively.⁴*

The EAIR for fungal infections was 22.4 per 100 PY; within this, the EAIR for Candida infections was 13.5 per 100 PY, with the most frequent types being oral candidiasis (9.3 per 100 PY) and vulvovaginal candidiasis (2.1 per 100 PY).⁴* This data is from a post-hoc analysis of the BE HEARD trials.⁴

Notes to Editors

• Draining tunnels: painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring¹²
• Non-draining tunnels: painful tunnels under the skin resulting from inflammation, frequently leading to induration, despite absence of pus discharge¹³
• Abscesses: tender but fluctuating masses with a diameter of >10 mm, surrounded by an erythematous area; the middle of an abscess contains pus¹⁴
• Inflammatory nodules: raised, three-dimensional, round, infiltrated lesions with a diameter of >10 mm¹⁴
• IHS4: the clinician-rated International HS Severity Score System (IHS4).¹⁴ This is a validated clinician-rated tool that assesses the severity of HS by assigning different weights to the number of inflammatory nodules/abscesses/draining tunnels.¹⁴ The resulting IHS4 score is arrived at by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).¹⁴ A total score of 3 or less signifies mild HS, 4–10 signifies moderate HS, and 11 or higher signifies severe HS¹⁴
• IHS4‑55/75/90/100: at least a 55%/75%/90%/100% improvement from baseline in a patient’s IHS4 total score.¹ IHS4-100 equates to complete resolution of inflammatory lesions.¹
• DLQI: Dermatology Life Quality Index (DLQI). DLQI scores of 0/1 entail no impact on quality of life, and scores of 0–5 entail no/small impact.³
• HiSQOL: HS Quality of Life (HiSQOL). A score ranging from 0–68, achievement of total score ≤14 entails no/mild impact on quality of life.³

About the BE HEARD trials

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).¹⁵ The primary endpoint data of BE HEARD I and BE HEARD II was HiSCR50 at Week 16.¹⁵ The two studies had a combined enrollment of 1,014 participants.¹⁵ In each study, patients were randomized 2:2:2:1 at week 16 (start of the 32-week maintenance treatment period) to bimekizumab 320 mg every two weeks, four weeks or a combination (BKZ Q2W/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W or placebo/BKZ Q2W).¹⁵ Receiving BKZ 320 mg (given as two subcutaneous injections of 160 mg or one subcutaneous injection of 320 mg) Q2W to Week 16, then Q4W thereafter is the approved dosing regimen (Q2W/Q4W) for the treatment of moderate to severe HS.^10,11

Patients who completed Week 48 could enroll in the open-label (OLE) extension.⁹ The OLE included patients receiving bimekizumab 320 mg Q2W and Q4W.⁹ Of 1,014 total patients, 556 who were randomized at baseline to bimekizumab in BE HEARD I and II completed Week 48 and entered the open-label extension study.⁹

These data were post hoc analyses and should be interpreted with caution as the analyses were not prespecified in the original protocols.

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

About hidradenitis suppurativa

Hidradenitis suppurativa (HS) is a chronic, progressive, painful and debilitating inflammatory skin disease that is associated with systemic manifestations.^12,16 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.^12,16 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^12,16  HS develops in early adulthood and affects approximately one percent of the population in most studied countries.^12,16  IL-17F and IL-17A are highly expressed in patients with HS, with IL-17F more abundant in HS serum and lesional skin than IL-17A.^6,7 IL-17F expression is significantly upregulated in lesions, with the highest expression in draining tunnels.⁸   

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

The approved indications for bimekizumab in the European Union are:¹¹

• 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%, 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 (injection site erythema, reaction, edema, pain, swelling, hematoma), 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: May 2026. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

*EU/EEA means European Union/European Economic Area.

Last accessed: September 2026.

For further information, contact UCB:

Investor Relations

Yvonne Naughton 

T +44.175.344.7521 

yvonne.naughton@ucb.com

Sahar Yazdian

T +32.2.559.91.37 

email sahar.yazdian@ucb.com

Corporate Communications

Laurent Schots 

T +32.2.559.92.64 

email laurent.schots@ucb.com

Brand Communications

Amy Cheshire

T +44.7786.743.577

email amy.cheshire@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).

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