Long-Term Data Support Sustained Bimekizumab Response in Hidradenitis Suppurativa

Three-year follow-up data from the phase 3 BE HEARD clinical program suggest that bimekizumab may provide durable reductions in inflammatory lesion burden and overall disease severity in adults with moderate to severe hidradenitis suppurativa (HS). The long-term findings, presented at the 15th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), extend previously reported efficacy through 48 weeks and offer insight into sustained outcomes with continued interleukin-17 (IL-17) pathway inhibition.¹

“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 life, but also due to the long-term structural damage and scarring they often cause,” Thrasyvoulos Tzellos, MD, PhD, Head Physician, Department of Dermatology, Nordland Hospital Trust, and associate professor at Institute of Clinical Medicine, University of Tromsø, Norway, said in a statement.² “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 BE HEARD I and II trials were multicenter, randomized, double-blind, placebo-controlled phase 3 studies evaluating bimekizumab in adults with moderate to severe HS.³ Together, the trials enrolled 1014 participants and assessed efficacy and safety over 48 weeks, with the primary endpoint being achievement of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16.³ Participants completing week 48 were eligible to enter an open-label extension study (BE HEARD EXT), in which all participants received bimekizumab.^1,2

The newly presented three-year data reflect observed-case analyses among patients originally randomized to bimekizumab who entered the extension and completed year-3 assessments (n=367). At three years, 40.1% of assessed patients achieved complete resolution of inflammatory lesions, defined as a 100% improvement in the International Hidradenitis Suppurativa Severity Score System (IHS4-100). Additionally, 59.1% and 77.4% achieved IHS4-90 and IHS4-75 responses, respectively.¹

Measures of disease severity also improved over time. The proportion of patients classified as having severe HS by IHS4 decreased from 87.4% at baseline to 14.7% at year three, while 59.4% were categorized as having mild or inactive disease. Mean draining tunnel counts declined from 3.8 at baseline to 0.9 at three years. Health-related quality-of-life improvements were also reported as sustained over the same period.¹

Bimekizumab is a humanized IgG1 monoclonal antibody, the only dual interleukin (IL)-17A and IL-17F targeting therapy approved for moderate-to-severe HS treatment in adults.³ The approved regimen for HS consists of BKZ Q2W to Week 16, then Q4W thereafter. In addition to HS, bimekizumab is also approved for treating axial spondyloarthritis, psoriatic arthritis, and plaque psoriasis in adults.²

References:

1. Tzellos T. Bimekizumab impact on dichotomous IHS4 response levels over 3 years in moderate to severe HS: results from BE HEARD EXT. Presented at: EHSF 2026.
2. UCB showcases three-year hidradenitis suppurativa data at EHSF: BIMZELX[®]▼(bimekizumab) achieved inflammatory lesion resolution and substantial disease severity improvements. News release. UCB. February 4, 2026. https://www.ucb.com/newsroom/press-releases/article/ucb-showcases-three-year-hidradenitis-suppurativa-data-at-ehsf-bimzelxrvbimekizumab-achieved-inflammatory-lesion-resolution-and-substantial-disease-severity-improvements
3. 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;403:2504–2519. doi:10.1016/S0140-6736(24)00101-6