UCB (UCB) CMD 2025 presentation summary

Market and product overview

• BIMZELX® (bimekizumab) is the first and only approved IL-17A and IL-17F inhibitor, with five distinct indications and approvals in over 50 countries, reaching more than 82,000 patients and over 100,000 patient-years of exposure.

• The product has rapidly gained market share in hidradenitis suppurativa (HS), achieving over 65% dynamic patient share by September 2024.

• Strategic pillars include advancing HS science, improving care and diagnosis, and addressing stigma for HS patients.

Clinical efficacy and patient outcomes

• Phase 3 BE HEARD I & II and BE HEARD EXT trials evaluated bimekizumab in moderate to severe HS, with 556 patients entering the open-label extension and 367 completing three years.

• HiSCR50 response rates were 79.9% at year 1 and 90.2% at year 3 (observed case), with sustained improvements in HiSCR75, HiSCR90, and HiSCR100.

• Dermatology Life Quality Index (DLQI) scores improved from a mean of 11.0 at baseline to 4.5 at year 3, with increasing proportions of patients reporting no impact on quality of life.

• Mean draining tunnel count decreased from 3.8 at baseline to 0.9 at year 3, indicating significant lesion reduction.

Safety profile

• Over three years, the incidence of any treatment-emergent adverse events (TEAEs) was 226.8 per 100 patient-years, with serious TEAEs at 7.2 per 100 patient-years.

• TEAEs leading to discontinuation were 6.0 per 100 patient-years, and the rate of TEAEs leading to death was 0.2 per 100 patient-years.

• The most common TEAEs included HS, coronavirus infection, and oral candidiasis; no new safety signals were identified.