Sustained Skin Pain and Draining Tunnel Improvements in Moderate-to-Severe Hidradenitis Suppurativa with BIMZELX® Phase 3 Study

Clinical trials have shown that BIMZELX® (bimekizumab-bkzx), a medication under investigation, has the potential to significantly alleviate skin pain and reduce the number of draining tunnels in individuals suffering from moderate-to-severe hidradenitis suppurativa (HS). The 48-week Phase 3 data from the BE HEARD I and BE HEARD II studies revealed that not only were the improvements in skin pain clinically meaningful, but they were also sustained over the course of the study. At the 16-week mark, patients who received BIMZELX showed a more significant reduction in draining tunnels compared to those who received a placebo, with these effects continuing or even improving by week 48.

Hidradenitis suppurativa is a chronic and debilitating skin condition characterized by painful nodules, abscesses, and draining tunnels, typically in areas such as the armpits, groin, and buttocks. The condition can have a profound impact on a patient's quality of life, causing physical discomfort and emotional distress due to the associated pain and social stigma.

The BE HEARD trials were comprehensive, involving 1,014 adult participants diagnosed with moderate-to-severe HS. They were randomly assigned to different treatment groups, with the primary outcome measure being the reduction in skin pain and the count of draining tunnels. The results were promising, with a significant proportion of patients experiencing a marked improvement in their condition.

Dr. Hadar Lev-Tov, an Associate Professor at the University of Miami, emphasized the importance of these findings, noting that pain is a common and challenging symptom in HS that affects patients' daily lives. The data from the Phase 3 trials indicate that with bimekizumab treatment, approximately 60% of patients reported a substantial improvement in their skin pain after 48 weeks.

Emmanuel Caeymaex, Executive Vice President at UCB, highlighted the company's dedication to developing effective treatments for HS and announced that they are working on regulatory applications to make bimekizumab available to the HS community worldwide.

It is important to note that BIMZELX is not yet approved for the treatment of HS by any regulatory authority globally, and its efficacy and safety profile for this indication are still under investigation. However, the positive outcomes from the Phase 3 trials offer hope for a new treatment option that could significantly improve the lives of those living with this challenging condition.

The detailed findings presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego showcased the impact of BIMZELX on pain and draining tunnel count, indicating sustained improvements over the 48-week study period. These results contribute to the growing body of evidence supporting the potential role of bimekizumab in managing HS and its associated symptoms.