Publication in The Lancet is announced of phase III bimekizumab trials in moderate to severe hidradenitis suppurativa – UCB

UCB, announced that The Lancet has published results from the Phase III BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of bimekizumab, an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

This article represents the primary publication of bimekizumab data from the two pivotal Phase III HS studies. HS is one of the most burdensome, chronic, systemic, inflammatory skin diseases that can have a profound impact on patients’ health-related quality of life.

“Publication of results from the BE HEARD I and II trials in The Lancet, a world-leading medical journal, reflects the significance of these data to the dermatology community. People living with hidradenitis suppurativa face high unmet medical needs. The positive results from these trials support global regulatory submissions for bimekizumab in this chronic inflammatory skin disease,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB.

“The Phase III studies with bimekizumab represent a significant milestone for the hidradenitis suppurativa community, and they include HiSCR75, a high threshold endpoint, as a key ranked secondary outcome. In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease. These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future,” said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S.

In April 2024, UCB announced that the European Commission granted marketing authorization for bimekizumab for the treatment of active moderate to severe HS in adults with an inadequate response to conventional systemic HS therapy. In April 2024, UCB also announced that the FDA accepted for review the supplemental biologics license application for bimekizumab-bkzx for the treatment of adults with moderate to severe HS. Other regulatory submissions for bimekizumab in the treatment of moderate to severe hidradenitis suppurativa are underway around the world.

See- “Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase III3 trials”-Prof Alexa B Kimball, MD , Prof Gregor B E Jemec, DMSci, Christopher J Sayed, MD, Prof Joslyn S Kirby, MD, Prof Errol Prens, PhD,
John R Ingram, DM et al. Published: May 22, 2024DOI:https://doi.org/10.1016/S0140-6736(24)00101-6.