Bimekizumab Demonstrates Long Term Efficacy in Hidradenitis Suppurativa

Bimekizumab (UCB, Bimzelx) has demonstrated high rates of hidradenitis suppurativa (HS) lesion clearance in new 3-year data from a long-term extension studies of the BE-HEARD studies announced by UCB.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.1 “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 new data are from the 2 multicenter, randomized, double-blind, placebo-controlled Phase 3 BE HEARD I and BE HEARD II studies. The primary endpoint of both studies was Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16. The studies had a combined enrollment of 1,014 participants, 556 of which were randomized, and then entered the open-label study, 2:2:2:1 to bimekizumab (BKZ) 320 mg every 2 weeks for the first initial 16 and then every 4 for the maintenance 32 weeks or a combination of the 2 based on HiSCR90 response (BKZ Q2W until 16 /Q2W, until 32 BKZ Q2W until 16/Q4W until 32, BKZ Q4W until 16/Q4W until 32 or placebo until 16/BKZ Q2W until 32).2 All patients who continued in the trial after Week 48 were subsequently switched to Q4W dosing by the end of year 4.

Of the participants in the open-label extension, 367 completed a lesion count assessment at year 3 and 40.1% (n = 147) achieved International HS Severity Score System (IHS4) 100 at that time point. Furthermore, 59.1% (n = 217) achieved IHS4 90 and 77.4% (n = 284) of those achieved IHS4-75.1

Importantly, the proportion of patients with severe HS fell from 87.4% (n = 486) at baseline to 14.7% (54/367) at 3 years and the proportion of people with mild or inactive HS rose from 0.0% (n = 0) at baseline to 59.4% (n = 218). The mean draining tunnel count also decreased from 3.8 (standard deviation [SD], 4.3) at baseline and to 0.9 (SD, 2.0) at year 3.1

Another abstract demonstrated meaningful improvements in health-related quality-of-life sustained to 3 years. UCB is presenting these data and more in 4 abstracts at the 15th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), held February 4-6, 2026, in San Giljan, Malta.

“The data at EHSF showed bimekizumab’s ability to reduce HS disease severity over an extended 3-year period. The depth and durability of efficacy reinforces its importance for both people living with HS and the clinical community,” Donatello Crocetta, Chief Medical Officer, UCB, added.1 “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.”

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.1

References

1. 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

2. 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. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/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.

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(10443):2504–19. DOI: 10.1016/S0140-6736(24)00101-6