BIMZELX[®] (bimekizumab-bkzx) two-year data at AAD showed potential to eliminate draining tunnels in hidradenitis suppurativa (HS), and reduction in disease burden
- Over half of patients had no draining tunnels (DTs) at two years: In 425 HS patients with ≥1 DTs at baseline, 55.7% (195/350) had no DTs at two years of treatment.≠ DTs are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring
- Clinically meaningful relief from skin pain: At two years of bimekizumab-bkzx treatment, 63.6% (279/439) of patients reported no or mild skin pain, compared to 10.0% (55/551) at baseline≠
- Sustained disease control across patient populations: Improvements in HiSCR50* and HiSCR75* sustained up to two years, regardless of age, sex, disease duration or severity, demonstrating efficacy regardless of patient demographics≠
- Improved responses with earlier treatment:Patients demonstrated efficacy at high HiSCR90* and HiSCR100* thresholds, and those who had a shorter duration from diagnosis to treatment had better outcomes, emphasizing the importance of early diagnosis and early treatment≠
Brussels (Belgium), March 7, 2025 – 14:00 (CET) – UCB, a global biopharmaceutical company, today announced two-year data from the BE HEARD^ trials for BIMZELX® (bimekizumab-bkzx) in moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),[1] continues to demonstrate sustained disease control and durable relief from key HS symptoms, including the potential to help prevent long-term structural damage caused by draining tunnels (DTs).[2],[3],[4],[5],[6],[7]
“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.2 In a subgroup of patients with ≥5 DTs at baseline, 41.1% (62/151) had no DTs at two years.2 The majority of patients with HS experience disease-associated pain, a highly burdensome symptom that negatively impacts their quality of life.[8],[9],[10] 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.3 Bimekizumab-bkzx was well tolerated over two years, with no new safety signals observed in the second year.5∞
“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 will be presented as seven posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, U.S., 7–11 March.2,3,4,5,6,7,[11] These abstracts complement other bimekizumab-bkzx data presented at AAD in moderate to severe plaque psoriasis,[12],[13],[14],[15],[16],[17] psoriatic arthritis,[18],[19],[20] and axial spondyloarthritis,[21],[22] emphasizing UCB’s leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.
The U.S. Food and Drug Administration (FDA) approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS) in November 2024.
^Further results from the BE HEARD trials evaluating the efficacy and safety profile of bimekizumab-bkzx will be presented later this year.
*HiSCR50/HiSCR75/HiSCR90/HiSCR100 is defined as at least a 50%/75%/90%/100% reduction in the total abscess and inflammatory nodule count from baseline with no increase from baseline in abscess or draining tunnel count.
≠Data are reported as observed case (OC). Patients completing the 48-week BE HEARD I&II studies could enroll in BE HEARD EXT and receive open-label BKZ 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40, and 44. Receiving bimekizumab-bkzx Q2W to Week 16, then Q4W thereafter is the approved dosing regimen (Q2W/Q4W). Results included patients receiving both Q2W and Q4W after Week 48.
∞The data presented in this paragraph are post-hoc analyses. Results included patients receiving both Q2W and Q4W after Week 48.
