Three-year BE HEARD data show bimekizumab delivers sustained lesion resolution and reduced disease severity in moderate to severe hidradenitis suppurativa.
Written By: Pharmacally Medical News Desk
Belgium-based biopharmaceutical company UCB has reported three-year follow-up data from the Phase 3 BE HEARD clinical program evaluating BIMZELX (bimekizumab) in adults with moderate to severe hidradenitis suppurativa (HS). The long-term results will be presented at the European Hidradenitis Suppurativa Foundation Conference and highlight sustained disease control, including complete resolution of inflammatory lesions in a substantial proportion of patients.
Topline results at three years
Bimekizumab is the first approved therapy to selectively inhibit both interleukin-17A and interleukin-17F. In patients who continued into the open-label extension, clinical benefits were maintained through three years of treatment.
At year three:
- 40.1% of assessed patients achieved IHS4-100, indicating complete resolution of inflammatory lesions
- 59.1% achieved IHS4-90, and 77.4% achieved IHS4-75
- The proportion of patients classified as severe HS fell from 87.4% at baseline to 14.7%
- 59.4% of patients were classified as having mild or inactive disease, compared with none at baseline
- Mean draining tunnel count declined from 3.8 to 0.9, suggesting meaningful reduction in chronic structural lesions
A separate analysis also showed durable improvements in health-related quality-of-life outcomes over the same period.
Bimekizumab showed a consistent and manageable safety profile over three years, with no new safety signals reported. The most common adverse events were upper respiratory tract infections and oral candidiasis, in line with the IL-17 inhibitor class. Treatment is contraindicated in patients with active infections, including tuberculosis, and caution is advised in patients with inflammatory bowel disease.
Clinical relevance
Draining tunnels and chronic inflammatory lesions are among the most disabling features of HS, often leading to pain, scarring, and long-term tissue damage.
According to Professor Thrasyvoulos Tzellos, Head Physician, Department of Dermatology, Nordland Hospital Trust, Bodø, Norway, the sustained resolution of these lesions over three years supports bimekizumab’s ability to deliver long-term inflammatory control and potentially limit disease progression.
Donatello Crocetta, Chief Medical Officer, UCB noted that the depth and durability of response reinforce the role of dual IL-17A and IL-17F inhibition as a long-term treatment strategy for HS, a disease with limited effective options.
About the BE HEARD program
The BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) studies were multicenter, randomized, double-blind, placebo-controlled Phase 3 trials enrolling 1,014 adults with moderate to severe HS. Patients who completed 48 weeks could enter an open-label extension (BE HEARD EXT, NCT04901195), where all participants ultimately received bimekizumab 320 mg every four weeks.
The three-year analysis includes patients originally randomized to bimekizumab who entered the extension and completed long-term assessments.
About BIMZELX (Bimekizumab)
BIMZELX is a humanized IgG1 monoclonal antibody that selectively inhibits IL-17A and IL-17F, two key cytokines involved in chronic inflammatory pathways. Dual inhibition is designed to provide deeper and sustained suppression of inflammation compared with IL-17A inhibition alone. In the EU, bimekizumab is approved for multiple immune-mediated diseases, including moderate to severe hidradenitis suppurativa.
About hidradenitis suppurativa
HS is a chronic, inflammatory skin disease characterized by recurrent nodules, abscesses, and draining tunnels, most commonly affecting intertriginous areas such as the axillae and groin. The disease typically begins in early adulthood and affects around one percent of the population in most studied regions, with a substantial impact on quality of life.
References
UCB showcases three-year hidradenitis suppurativa data at EHSF: BIMZELX[®]▼(bimekizumab) achieved inflammatory lesion resolution and substantial disease severity improvements, 04 February 2026, UCB showcases three-year hidradenitis suppurativa data at EHSF: BIMZELX[®]▼(bimekizumab) achieved inflammatory lesion resolution and substantial disease severity improvements | UCB
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa (BE HEARD I), ClinicalTrials.gov ID NCT04242446, https://clinicaltrials.gov/study/NCT04242446
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa (BE HEARD II), ClinicalTrials.gov ID NCT04242498, https://clinicaltrials.gov/study/NCT04242498
A Study to Test the Long-term Treatment of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa (BE HEARD EXT), ClinicalTrials.gov ID NCT04901195, https://clinicaltrials.gov/study/NCT04901195