Three-Year Data Detail Bimekizumab Outcomes in Hidradenitis Suppurativa
Key Takeaways
- Post hoc analyses from the Phase 3 BE HEARD program and its open-label extension evaluated bimekizumab outcomes in moderate-to-severe hidradenitis suppurativa (HS) through 3 years, including inflammatory lesions, tunnels, quality of life, and safety.
- Among biologic-naïve patients, mean draining tunnel count decreased from 3.3 at baseline to 0.8 at 3 years. A separate analysis found that 30.7% of patients completing year 1 had no total tunnels, compared with 14.5% of the bimekizumab group at baseline.
- Three-year analyses reported sustained quality-of-life improvements and no new safety signals, although the post hoc, observed-case analyses and open-label extension design limit interpretation.
New analyses of the Phase 3 BE HEARD clinical program presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026 evaluated long-term inflammatory lesions, tunnels, quality of life, and safety with bimekizumab (Bimzelx; UCB) in adults with moderate-to-severe hidradenitis suppurativa (HS).
BE HEARD I and II enrolled a combined 1,014 patients, with eligible patients continuing into the open-label BE HEARD EXT study. The EADV analyses were post hoc and included observed-case data through 3 years.
Analyses Examine HS Tunnels and Long-Term Outcomes
Among biologic-naïve patients, mean draining tunnel count decreased from 3.3 at baseline to 0.8 at 3 years; among biologic-experienced patients, mean count decreased from 5.6 to 1.3. Rates of complete draining tunnel resolution varied according to baseline tunnel burden and prior biologic exposure.
A separate analysis evaluated total tunnels, including draining and nondraining tunnels. Among 868 bimekizumab-treated patients, 14.5% had no total tunnels at baseline. Among 613 patients completing year 1, 30.7% had no total tunnels and 56.6% had no draining tunnels.
Quality-of-life outcomes were also evaluated through 3 years. Among patients included in the observed-case analysis, mean Dermatology Life Quality Index score decreased from 11.0 at baseline to 4.5 at 3 years. At 3 years, 38.1% had DLQI scores of 0 or 1, while 71.7% had scores of 0 to 5.
The 3-year safety analysis included 995 patients with 2,118.6 patient-years of bimekizumab exposure. The exposure-adjusted incidence rate for any treatment-emergent adverse event was 243.3 per 100 patient-years. Oral candidiasis occurred at a rate of 9.3 per 100 patient-years.
The investigators cautioned that the analyses were post hoc and were not prespecified in the original study protocols.