UCB Reveals 3-Year BE HEARD Results for Bimekizumab in HS Treatment
UCB Reports Promising Three-Year Outcomes for Bimekizumab in Hidradenitis Suppurativa
UCB has unveiled compelling new data reflecting three-year outcomes for bimekizumab (marketed as BIMZELX) in patients suffering from moderate to severe hidradenitis suppurativa (HS). This data highlights the sustained resolution of inflammatory lesions and significant reductions in overall disease severity (Source: UCB press release, EHSF Conference). The findings, drawn from the pivotal phase 3 BE HEARD clinical program and its open-label extension, will be presented at the upcoming 15th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) in San Giljan, Malta. These results offer some of the longest-duration efficacy observations recorded for a therapy targeting IL-17A and IL-17F in HS to date.
Study Overview and Methodology
The three-year analysis centers on individuals with moderate to severe HS who were randomized to receive bimekizumab during the 48-week, double-blind, placebo-controlled trials known as BE HEARD I and BE HEARD II. Following this initial period, participants entered the BE HEARD open-label extension (BE HEARD EXT).
A total of 1,014 participants were enrolled across these pivotal trials, with 556 patients initially assigned to bimekizumab successfully completing the 48-week period and subsequently entering the extension phase. Among these individuals, 367 had available assessments for lesion count at the three-year mark.
Long-Term Efficacy Findings
Post the controlled trial phase, patients transitioned to open-label bimekizumab, receiving doses of 320 mg either every two weeks or every four weeks, with all participants ultimately shifting to a four-week dosing schedule by the end of year three. Utilizing the clinician-rated International HS Severity Score System (IHS4), substantial long-term improvements in inflammatory lesion burden were documented.
At the three-year follow-up, an impressive 40.1% (147 out of 367) of the assessed patients achieved an IHS4-100 response, indicating complete resolution of inflammatory lesions, which includes nodules, abscesses, and draining tunnels. Additionally, notable near-complete responses were observed: 59.1% (217/367) of participants met the IHS4-90 criteria, while 77.4% (284/367) achieved IHS4-75, reflecting at least 90% and 75% improvement from baseline IHS4 scores, respectively.
Shifts in Disease Severity Distribution
Beyond individual response rates, the analysis revealed a significant shift in the overall distribution of disease severity over time. At baseline, a striking 87.4% (486/556) of patients within the bimekizumab group were categorized as having severe HS per IHS4 criteria. By the three-year mark, this proportion dramatically decreased to 14.7% (54/367). Conversely, the percentage of patients classified with mild or inactive disease (IHS4 ≤3) rose from 0% at baseline to an encouraging 59.4% (218/367) after three years.
These findings suggest a remarkable transition for the majority of patients from moderate or severe HS to a milder disease state throughout the course of long-term treatment. The number of draining tunnels, often linked to chronic tissue damage, scarring, and significant morbidity, also displayed a substantial decline.
Specifically, the mean count of draining tunnels dropped from an average of 3.8 (±4.3) at baseline to just 0.9 (±2.0) after three years. Given the structural and symptomatic burden that these tunnels represent, their reduction is not only clinically meaningful but also aligns closely with the reported rates of IHS4-100 response.
Improvements in Quality of Life
Alongside the objective measures of lesion resolution and disease severity, a separate analysis indicated sustained, significant improvements in key health-related quality of life outcomes over the three-year period, emphasizing the broader impact of effective long-term inflammatory control in HS.
Expert Commentary
“The inflammatory lesions associated with HS, particularly draining tunnels, can be profoundly devastating for individuals living with this condition—not only due to pain and the severe impact on daily life, but also because of the lasting structural damage and scarring they often cause,” commented Professor Thrasyvoulos Tzellos, head physician at the Department of Dermatology at Nordland Hospital Trust in Bodø, Norway, in a press release.
“These data demonstrate that bimekizumab achieves high long-term resolution rates for these lesions, highlighting its sustained control of inflammation and potential to prevent structural damage and disease progression” (Source: UCB press release, EHSF Conference).
Bimekizumab stands out as the first and only monoclonal antibody that selectively inhibits both IL-17A and IL-17F, which are crucial cytokines involved in the pathophysiology of various chronic inflammatory diseases.
Regulatory Approval and Future Outlook
In November 2024, the therapy received approval from the U.S. FDA for adult patients with moderate-to-severe HS, with a dosing regimen of 320 mg every two weeks for the first 16 weeks, followed by 320 mg every four weeks thereafter (Source: UCB press release, FDA Approval). Dr. Donatello Crocetta, MD, MBA, UCB’s Chief Medical Officer, noted, “The data presented at EHSF illustrate bimekizumab’s capability to significantly reduce HS disease severity over an extended three-year period. The depth and durability of efficacy reinforce its importance for both patients living with HS and the clinical community.”
“We are excited to commence 2026 with enhanced long-term clinical evidence that reflects UCB’s commitment to delivering innovative treatment options, and we eagerly anticipate sharing additional bimekizumab data at the upcoming AAD conference later this quarter” (Source: UCB press release, EHSF Conference).
Sources
- UCB showcases three-year hidradenitis suppurativa data at EHSF: BIMZELX® (bimekizumab) achieved inflammatory lesion resolution and substantial disease severity improvements. Published February 4, 2026. Accessed 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
- 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. Published November 20, 2024. Accessed February 4, 2026. 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