Bimzelx (bimekizumab) two-year data at EHSF 2025 demonstrate sustained disease control in hidradenitis suppurativa – UCB

UCB announced long-term data from the BE HEARD trials for Bimzelx (bimekizumab) in moderate to severe hidradenitis suppurativa (HS). These two-year data, building on the established efficacy profile of bimekizumab in HS, showcase that its unique dual inhibition offers a durable treatment option for this challenging, chronic skin condition.

“For people living with HS, draining tunnels associated with moderate and severe disease can be incredibly distressing and painful – often derailing daily life,” 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. “These new, specific two-year data demonstrate bimekizumab’s ability to provide sustained disease control, meaning a shift towards mild disease characterized by the absence of draining tunnels, offering hope for long-term disease management and reduced burden for HS patients.”

Among patients who achieved response to bimekizumab at one year, over 85.0% maintained response across a range of endpoints to two years (percentage responders at Week 48 through Week 96: 90.0% (332/369) maintained HiSCR50; 86.9% (265/305) maintained HiSCR75; 86.0% (234/272) maintained DLQI MCID). HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess and inflammatory nodule or draining tunnel count Improvements in disease severity, as measured by IHS4π (a validated clinician-rated tool that assigns different weights to the number of inflammatory nodules, abscesses and draining tunnels (DTs). The presence of a draining tunnel is sufficient to classify an HS patient as at least moderate), were demonstrated with the majority of patients shifting over two years from severe to mild and moderate disease (baseline to two-year data: mild: 0.0% to 53.1% (237/446); moderate:12.6% (70/556) to 26.5% (118/446); severe: 87.4% (486/556) to 20.4% (91/446). The mean (SD) draining tunnel count also decreased over two years. Additionally, patients reported that gradual improvement to no/mild severity of symptoms translated to improved health-related quality of life over two years. This highlights the impact of bimekizumab in providing durable control of symptoms which contribute to the profound negative effects of HS on patients’ quality of life.

“As the first presentation of bimekizumab data this year, we are thrilled it demonstrates the durability of response in HS treatment,” said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. “Sustained flare control, maintenance of response and improvement across multiple measures of disease severity through two years show how bimekizumab can transform outcomes for people living with HS. These data confirm our commitment to improving the lives of those living with HS, now and into the future.”

Abstracts were presented as two posters and three oral presentations, at the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) in Vilnius, Lithuania. Further results from BE HEARD EXT evaluating the efficacy and safety profile of bimekizumab will be presented later this year.

Bimekizumab two-year data in HS presented at EHSF 2025:

Data were pooled from the BE HEARD I&II studies and BE HEARD EXT. Week 48 completers could enroll in BE HEARD EXT and receive open-label BKZ 320 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) based on ≥90% HS Clinical Response (HiSCR90; averaged from BE HEARD I&II Weeks 36, 40 and 44). The approved dosing regimen is 320 mg Q2W up to Week 16 and Q4W thereafter. Patients randomized to receive BKZ from baseline in BE HEARD I&II and who entered BE HEARD EXT were included (BKZ Total group). Of these 556 patients, 446 patients in the open-label extension study completed Week 96 (two years).

i) IHS4: Patients demonstrated improvements in disease severity as measured by the International Hidradenitis Suppurativa Severity Score System (IHS4), a validated clinician-rated tool that assigns different weights to the number of inflammatory nodules, abscesses and draining tunnels (DTs). The proportion of patients in the severe (≥11 points) IHS4 stage decreased from 87.4% (486/556) at baseline to 20.4% (91/446) at Week 96.

ii) IHS4-75 and IHS4-90: IHS4-75 and IHS4-90 are stringent clinical scores based on an improvement of at least 75% and 90%, respectively, in IHS4 total score from baseline. The proportion of patients who achieved IHS4-75 and IHS4-90 at Week 96 was 71.7% (320/446) and 50.9% (227/446), respectively.

iii) Impact on flares: The low rate of flares seen with bimekizumab treatment at Week 48 was maintained to two years, with 83.4% (372/446) of patients remaining flare-free at Week 96.5 A flare was defined as ≥25% increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to baseline.

iv) Draining tunnels (DTs): The mean (SD) DT count for patients decreased from 3.8 (4.3) at baseline to 1.1 (2.3) at Week 96.

v) Maintenance of response: Among patients who responded to bimekizumab treatment at one year, the majority maintained response to two years. Among Week 48 HiSCR50 and HiSCR75 responders, 90.0% (332/369) and 86.9% (265/305), respectively, maintained response through Week 96. a) HiSCR50 and HiSCR75 are defined as at least either a 50 or 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess and inflammatory nodule or draining tunnel count. b) Among Week 48 Dermatology Life Quality Index (DLQI) minimal clinically important difference (MCID) responders, 86.0% (234/272) maintained response through Week 96.

vi) Symptom severity impact on health-related quality of life (HRQoL): Data investigated the association between the severity of HS core symptoms beyond skin pain (itch, smell or odor and drainage or oozing) with HRQoL over 2 years. Patients reporting no/mild symptom severity demonstrated greater improvements in HRQoL, as measured by HS Quality of Life (HiSQOL) patient-reported outcome questionnaire, compared with those reporting moderate and severe/very severe symptoms.