UCB's Bimekizumab Shows Sustained Efficacy Against HS Abscesses, Tunnels, and Pain Over 3 Years

UCB has announced new three-year results from the BE HEARD clinical program evaluating bimekizumab-bkzx (BIMZELX) in adults with moderate-to-severe hidradenitis suppurativa (HS).¹ The data, presented at the 2025 Symposium on Hidradenitis Suppurativa Advances (SHSA) in Nashville, Tennessee, demonstrates sustained improvements in skin pain and resolution of draining tunnels with continued treatment across 3 years.

“These results for bimekizumab show meaningful improvements in inflammatory lesions and skin pain to three years, and offer a valuable perspective on its sustained efficacy for patients with HS,” said Donatello Crocetta, Chief Medical Officer at UCB. “Our research presented at SHSA underscores UCB’s commitment to providing long-term data addressing key clinical features of chronic inflammatory conditions with a high unmet need.”¹

Bimekizumab is the first and only monoclonal antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, key cytokines implicated in the pathophysiology of several chronic inflammatory diseases. In November 2024, the therapy received US FDA approval for adult patients with moderate-to-severe HS at a dosing regimen of 320 mg every 2 weeks to week 16, followed by 320 mg every 4 weeks thereafter.²

Study Design and Long-Term Extension

The BE HEARD program was comprised of 2 phase 3, randomized, double-blind, placebo-controlled studies (BE HEARD I and II), enrolling a combined 1,014 adults with moderate-to-severe HS. Patients were randomized to receive bimekizumab320 mg every 2 or 4 weeks or placebo, followed by open-labelbimekizumab in the extension phase.

Of the initial cohort, 556 patients who had been randomized to bimekizumab at baseline completed week 48 and entered the BE HEARD EXT open-label extension. Of these, 446 completed week 96, and 367 completed through week 148. Following week 48, all participants transitioned to every 4-week dosing per protocol.

Safety outcomes were assessed in all patients who received 1 or more doses of bimekizumab across BE HEARD I, II, and EXT. The long-term safety profile remained consistent with that observed in earlier phases, with no new safety signals identified.

Sustained Reductions in Pain, Draining Tunnels and Abscesses

Draining tunnels—painful, pus-discharging lesions resulting from chronic inflammation—are a major contributor to morbidity and scarring in HS. In a post-hoc analysis of the BE HEARD long-term extension study (BE HEARD EXT), patients who entered the open-label phase after completing the 48-week BE HEARD I and II trials continued to demonstrate significant improvement over 3 years.

Among patients with at least 1 draining tunnel at baseline (n =4 25), 48.2% had none after 1 year, rising to 62.9% at 3 years. Similarly, among those with at least 1 abscess at baseline (n = 381), 75.3% were abscess-free at 1 year, and 83.5% at 3 years.

For patients who began the study without draining tunnels (n = 131), 87.8% remained tunnel-free after 1 year, increasing to 90.8% at 3 years, highlighting the sustained prevention of new lesion formation.

Using the HS Symptom Questionnaire (HSSQ) skin pain item (0–10 scale, with 0–2 indicating no/mild pain), only 10% of patients reported no or mild pain at baseline. This proportion rose to 51.7% at 1 year and 65.8% at 3 years.

“Reduction of draining tunnels and abscesses is key for patients with HS because of the huge impact these lesions have on patients’ lives,” Professor Steven Daveluy, MD, board-certified dermatologist at Wayne State University in Detroit, Michigan, and board member of the HS Foundation, said in the statement. “These new data, showing high rates of reduction of these painful lesions to three years, demonstrate the sustained symptom relief bimekizumab provides and suggest the possibility of reducing the structural damage frequently seen with HS that can be so devastating for patients.”¹

References

1. BIMZELX® (bimekizumab-bkzx) Data in Hidradenitis Suppurativa Showed Improvements in Pain and Resolution of Draining Tunnels Sustained to Three Years. News release. UCB. Published October 31, 2025. Accessed October 31, 2025. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-bimekizumab-bkzx-data-in-hidradenitis-suppurativa-showed-improvements-in-pain-and-resolution-of-draining-tunnels-sustained-to-three-years

2. UCB receives US FDA approval for BIMZELX® (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate-to-severe hidradenitis suppurativa. News Release. UCB. Published November 20, 2024. Accessed October 31, 2025. 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