UCB announces positive 48-week results for BIMZELX in Hidradenitis Suppurativa studies

At the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, UCB, a leading global biopharmaceutical company, shared promising 48-week post-hoc analyses from the BE HEARD I and BE HEARD II Phase 3 studies of BIMZELX in adults with moderate-to-severe hidradenitis suppurativa (HS). These studies highlight clinically meaningful improvements in skin pain and reductions in draining tunnel counts, offering new hope for those suffering from this chronic skin condition.

Patients treated with BIMZELX reported significant improvements in skin pain up to 48 weeks across various outcomes, including the HS Symptom Questionnaire (HSSQ) skin pain item, the Patient Global Impression of Severity of Skin Pain (PGI-S-SP), and the Change in Severity of Skin Pain (PGI-C-SP). Additionally, BIMZELX-treated patients showed greater reductions in draining tunnel count compared to those on placebo at Week 16, with responses either sustained or improved by Week 48.

Dr. Hadar Lev-Tov, MD, an Associate Professor at the University of Miami’s Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, emphasized the impact of HS on patients’ quality of life, stating, “The majority of patients with hidradenitis suppurativa experience disease-associated pain that can impact their quality-of-life. Data from the Phase 3 studies show that after 48 weeks of bimekizumab treatment approximately six out of ten patients rated their skin pain ‘much better’. These long-term results are encouraging, especially given that pain is a common complaint in people with HS that dermatologists struggle with daily.”

Emmanuel Caeymaex, Executive Vice President of Immunology Solutions and Head of U.S. at UCB, highlighted the commitment to addressing HS, “The bimekizumab 48-week long-term data in moderate-to-severe hidradenitis suppurativa showed sustained improvements in skin pain and draining tunnel count. These positive results underscore our commitment to developing solutions that make a meaningful and lasting difference to peoples’ lives. We are actively pursuing regulatory applications across the globe to bring bimekizumab to the hidradenitis suppurativa community.”

Despite the promising results, it’s important to note that BIMZELX is not yet approved for the treatment of moderate-to-severe HS by any regulatory authority worldwide. The efficacy and safety profile of BIMZELX in the treatment of HS remain under investigation.

The findings from the BE HEARD I and II studies represent a significant step forward in the treatment of hidradenitis suppurativa, a condition that has long challenged patients and healthcare providers alike. The sustained improvements in skin pain and draining tunnel counts over 48 weeks suggest that BIMZELX could potentially offer a new, effective treatment option for those with moderate-to-severe HS. This development is particularly noteworthy considering the limited options currently available for managing this painful and often debilitating condition.