Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety Profile

Christos C. Zouboulis, MD, PhD
Credit: ESAAM

Use of bimekizumab (Bimzelx) was associated with sustained disease control for up to 2 years in hidradenitis suppurativa (HS), according to new data from the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF).¹

A presentation of long-term data from the BE HEARD trials, results indicate use of bimekizumab for up to 96 weeks was associated with reduced symptoms of HS, a low rate of flares, and improved health-related quality of life among patients with moderate to severe HS.

“For people living with HS, draining tunnels associated with moderate and severe disease can be incredibly distressing and painful – often derailing daily life,” said Christos C. Zouboulis, MD, PhD, president of the EHSF, 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 in Germany.¹ “These new, specific 2-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.”

A humanized interleukin-17A and interleukin-17F antagonist marketed by UCB Pharma, bimekizumab boasts indications for moderate-to-severe HS, psoriatic arthritis, and more, with its initial approval for moderate to severe plaque psoriasis dating back to October 2023. The November 2024 approval of bimekizumab for moderate to severe HS, which marked the first time an IL-17A and IL-17F inhibitor received this indication, was based on data from the BE HEARD I and II trials.^1,2

Randomized, double-blind, placebo-controlled, parallel group, multicenter, phase 3 trials, the BE HEARD I and II trials had a combined enrollment of 1014 participants and assessed the efficacy and safety of bimekizumab relative to placebo for Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at week 16.^1,2

At EHSF 2025, investigators presented pooled data from BE HEARD I, BE HEARD II, and the BE HEARD EXT studies demonstrating the long-term efficacy of bimekizumab in patients with moderate to severe HS. Among 556 patients who received bimekizumab from baseline, 446 completed treatment through week 96.¹

Results of the long-term analysis indicated disease severity, as measured by the International Hidradenitis Suppurativa Severity Score System (IHS4), showed significant improvement, with the proportion of patients in the severe stage decreasing from 87.4% at baseline to 20.4% at week 96. Additionally, 71.7% of patients achieved IHS4-75 and 50.9% achieved IHS4-90 by week 96.¹

Investigators also highlighted 83.4% of patients flare-free at week 96, which was consistent with rates observed at week 48. The mean number of draining tunnels decreased from 3.8 to 1.1, further supporting treatment efficacy. Among patients who achieved HiSCR50 and HiSCR75 at 2eek 48, 90.0% and 86.9%, respectively, maintained response through week 96.¹

When assessing quality of life, 86.0% of week 48 Dermatology Life Quality Index responders sustained their response to week 96. Investigators pointed out patients who reported no or mild symptom severity experienced greater improvements in the HS Quality of Life questionnaire relative to those reporting moderate to severe symptoms.¹

“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 and head of Patient Evidence at UCB.¹ “Sustained flare control, maintenance of response and improvement across multiple measures of disease severity through 2 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.”
References:

1. UCB. BIMZELX[®](bimekizumab) two-year data at EHSF 2025 demonstrate sustained disease control in hidradenitis suppurativa (HS). UCB. February 12, 2025. Accessed February 12, 2025. https://www.ucb.com/newsroom/press-releases/article/bimzelxrvbimekizumab-two-year-data-at-ehsf-2025-demonstrate-sustained-disease-control-in-hidradenitis-suppurativa-hs.

2. UCB. UCB receives U.S. FDA approval for BIMZELX[®] (bimekizumab-BKZX) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa. UCB. November 20, 2024. Accessed February 12, 2025. https://www.ucb.com/newsroom/press-releases/article/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa.