UCB showcases three-year hidradenitis suppurativa data at EHSF: BIMZELX[®]▼(bimekizumab) achieved inflammatory lesion resolution and substantial disease severity improvements

Brussels (Belgium), February 4, 2026 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials^ for BIMZELX^®▼ (bimekizumab) in moderate to severe HS. Bimekizumab, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL 17F),¹ demonstrated total resolution of inflammatory lesions and substantial improvements in disease severity, sustained to three years.^2,3,4,5 This data will be presented at the 15th Conference of the European Hidradenitis Suppurativa Foundation (EHSF).

“The inflammatory lesions seen in HS, particularly draining tunnels, can be devastating for people living with this disease – not only because of the pain and profound impact on daily life, but also due to the long-term structural damage and scarring they often cause,” said Professor Thrasyvoulos Tzellos, Head Physician, Department of Dermatology, Nordland Hospital Trust, Bodø, Norway. “These data show that bimekizumab delivers high long-term resolution rates of these lesions, underscoring its sustained control of inflammation and potential to avoid structural damage and disease progression.”

“The data at EHSF showed bimekizumab’s ability to reduce HS disease severity over an extended three-year period. The depth and durability of efficacy reinforces its importance for both people living with HS and the clinical community,” said Donatello Crocetta, Chief Medical Officer, UCB. “We are proud to begin 2026 with more robust long-term clinical evidence that reflects UCB’s commitment to delivering unique treatment options, and we look forward to sharing additional bimekizumab data at AAD later this quarter.”

UCB will present four abstracts on bimekizumab in HS at the 15th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), 4–6 February 2026, in San Giljan, Malta. These data underscore UCB’s leadership in providing rigorous clinical research and ensuring its solutions have a real, lasting impact for people living with severe chronic inflammatory diseases.

Of people with HS at baseline, 40.1% (147/367) of those assessed at three years achieved IHS4 100.^2* In addition, 59.1% (217/367) and 77.4% (284/367) of those assessed at three years achieved IHS4 90 and IHS4-75, respectively.^2* In a second analysis, the proportion of people with severe HS, as assessed by IHS4, fell from 87.4% (486/556) at baseline to 14.7% (54/367) at three years.^3* Further, the proportion of people with mild or inactive HS, as assessed by IHS4, rose from 0.0% (0/556) at baseline to 59.4% (218/367) at three years.^3* This analysis also showed the mean (standard deviation given in brackets) draining tunnel count was 3.8 (4.3) at baseline and decreased to 0.9 (2.0) at year three.^3* A separate analysis demonstrated meaningful improvements in a key health-related quality-of-life outcome sustained to three years.^5* 

*OC: Data are reported as observed case (OC). The data reported are from an observational, open label study. 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 44.⁶ 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.^2,3,4,5 The approved dosing regimen is bimekizumab 320 mg Q2W to Week 16 and then 320 mg Q4W thereafter.¹ 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.

Notes to Editors

• IHS4: the clinician-rated International HS Severity Score System (IHS4).⁷ 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.⁷ 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).⁷ A total score of 3 or less signifies mild HS, 4–10 signifies moderate HS, and 11 or higher signifies severe HS⁷
• IHS4‑55/75/90/100: at least a 55%/75%/90%/100% improvement from baseline in a patient’s IHS4 total score.² IHS4-100 equates to complete resolution of inflammatory lesions.²
• Inflammatory nodules: raised, three-dimensional, round, infiltrated lesions with a diameter of >10 mm⁷
• Abscesses: tender but fluctuating masses with a diameter of >10 mm, surrounded by an erythematous area; the middle of an abscess contains pus⁷
• Draining tunnels: painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring⁸ 

About hidradenitis suppurativa

Hidradenitis suppurativa (HS) is a chronic, painful and potentially debilitating inflammatory skin disease that is associated with systemic manifestations.^8,9 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.^8,9 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^8,9 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.^8,9

^About 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).¹⁰ The primary endpoint of BE HEARD I and BE HEARD II was HiSCR50 at Week 16.¹⁰ The two studies had a combined enrollment of 1,014 participants.¹⁰ In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) 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).¹⁰ Receiving BKZ Q2W to Week 16, then Q4W thereafter is the approved dosing regimen (Q2W/Q4W) for the treatment of HS.¹

Patients who completed Week 48 could enroll in the open-label extension.⁶ 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.² Of these, 367 patients in BE HEARD EXT completed a lesion count assessment at year three.²

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

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

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.¹ 

About BIMZELX^®▼(bimekizumab) EU/EEA

The approved indications for bimekizumab▼ in the European Union are:¹

• 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: April 2025. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

Last accessed: February 2026.

▼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
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email adriaan.snauwaert@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).

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References

1. BIMZELX® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: February 2026.
2. Tzellos T. Bimekizumab impact on dichotomous IHS4 response levels over 3 years in moderate to severe HS: Results from BE HEARD EXT. 2026. EHSF. #S-11-02.
3. Zouboulis C. Bimekizumab improves HS disease severity as measured by IHS4 and draining tunnel count over 3 years: Data from BE HEARD EXT. 2026. EHSF. #232.
4. Grimstad Ø. The disease burden and unmet treatment need of patients with hidradenitis suppurativa in Denmark and Norway: Real-world data from the HISREG registry. 2026. EHSF. #S-03-06.
5. Porter M. Bimekizumab improves intimacy outcomes over 3 years in moderate to severe HS: Data from BE HEARD EXT. 2026. EHSF. #231.
6. Zouboulis CC, Garg A, Sayed CJ, 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]. Skin. 2024;8(6):s473. EADV. 7925.
7. Zouboulis CC, Tzellos T, Kyrgidis A, et al. Development and validation of the International Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to assess HS severity. Br J Dermatol. 2017;177(5):1401–9.
8. Sabat R, Jemec GBE, Matusiak Ł, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
9. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64.
10. 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.