UCB, a leading global biopharmaceutical company, has announced the publication of results from the Phase 3 BE HEARD I and BE HEARD II trials in The Lancet. These trials evaluated the effectiveness and safety of bimekizumab, an inhibitor of IL-17A and IL-17F, for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults. This publication marks the primary release of bimekizumab data from these pivotal Phase 3 studies, addressing a significant unmet medical need in the dermatology community.
Hidradenitis suppurativa (HS) is a chronic, systemic, inflammatory skin disease that profoundly affects patients’ health-related quality of life. The positive outcomes from the BE HEARD trials underscore the potential of bimekizumab in addressing this challenging condition. Emmanuel Caeymaex, Executive Vice President and Chief Commercial Officer at UCB, emphasized the importance of these findings for people living with HS, highlighting the support for global regulatory submissions of bimekizumab in this indication.
Lead Investigator Alexa B. Kimball, MD, MPH, highlighted the significance of the Phase 3 studies, particularly emphasizing the inclusion of HiSCR75 as a key ranked secondary outcome. Bimekizumab consistently demonstrated sustained improvements in both clinical and patient-reported outcomes, providing strong evidence for targeting IL-17A and IL-17F as a promising therapeutic strategy for HS.
In April 2024, UCB received marketing authorization from the European Commission for bimekizumab in the treatment of active moderate to severe HS in adults with inadequate responses to conventional systemic therapy. Additionally, the U.S. Food and Drug Administration accepted for review the supplemental biologics license application for bimekizumab-bkzx for the treatment of adults with moderate to severe HS. Regulatory submissions for bimekizumab in HS treatment are also underway in other parts of the world.
The BE HEARD I and BE HEARD II trials were rigorous Phase 3 studies involving over 1,000 participants with moderate to severe HS. These trials demonstrated that bimekizumab significantly improved HS signs and symptoms compared to placebo, with responses maintained up to Week 48. The safety profile of bimekizumab was consistent with previous trials, with no new safety concerns identified.
Hidradenitis suppurativa (HS) is characterized by painful nodules, abscesses, and fistulas, primarily in areas such as the armpits, groin, and buttocks. It affects approximately one percent of the population in most studied countries and significantly impacts patients’ quality of life. Bimekizumab, a humanized monoclonal antibody targeting IL-17A and IL-17F, offers a promising treatment option for this challenging condition.
Bimekizumab is already approved for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis in various regions. Common adverse reactions include upper respiratory tract infections and oral candidiasis. Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or any excipients and in those with clinically important active infections. Close monitoring is necessary for signs of infections and inflammatory bowel disease during treatment with bimekizumab. Live vaccines should not be administered to patients receiving bimekizumab.
