Bimzelx Reduces Disease Burden in HS

“Draining tunnels cause debilitating symptoms such as pain and malodorous discharge, and can often result in irreversible scarring,” said Christopher Sayed, MD, University of North Carolina, Chapel Hill. “These exciting results reveal that treatment with bimekizumab-bkzx reduces draining tunnels and the associated disease burden in patients with moderate to severe HS.”

Among patients with one or more DTs at baseline, the proportion who had 1–2, 3–5, or >5 DTs at two years were 26.6% (93/350), 11.1% (39/350), and 6.6% (23/350) respectively. In addition, 55.7% (195/350) had no DTs at two years. In a subgroup of patients with ≥5 DTs at baseline, 41.1% (62/151) had no DTs at two years. The majority of patients with HS experience disease-associated pain, a highly burdensome symptom that negatively impacts their quality of life. In addition to a reduction in clinical severity of skin pain with bimekizumab-bkzx, measured by Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) skin pain scores, the proportion of patients reporting no impact on their Health Related Quality of Life (HRQoL) due to pain, based on HiSQOL pain item score, increased from 2.7% (15/551) at baseline to 44.6% (196/439) at two years. Bimekizumab-bkzx was well tolerated over two years, with no new safety signals observed in the second year.

“This new long-term data underscores UCB’s dedication to improving outcomes for people with HS, by providing a treatment option that offers sustainable clinical improvements while helping to prevent the long-term structural damage associated with draining tunnels,” said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. “The substantial and sustained clinical improvements addressing a wide range of HS symptoms across broad patient populations highlights bimekizumab-bkzx’s potential to address the unmet needs of people living with HS.”

UCB’s data in HS was presented as seven posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. These abstracts complement other bimekizumab-bkzx data presented at AAD in moderate to severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis, emphasizing UCB’s leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.

The FDA approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS) in November 2024.

About BE HEARD trials: The efficacy and safety profile of bimekizumab were evaluated in adult patients with moderate to severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase III studies (BE HEARD I and BE HEARD II). The two studies had a combined enrolment of 1,014 participants. In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) to bimekizumab 320 mg every two weeks, four weeks or a combination (Q2W/Q2W, BKZQ2W/Q4W, BKZQ4W/Q4W or placebo/BKZQ2W). Patients who completed Week 48 could enroll in the open-label extension. Of 1,014 total patients, 556 patients randomized at baseline to bimekizumab in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96.