UCB shares positive two-year Bimzelx results in hidradenitis suppurativa

UCB has released encouraging two-year results for its drug Bimzelx (bimekizumab), targeting moderate-to-severe hidradenitis suppurativa (HS). These findings come from the phase 3 BE HEARD I and BE HEARD II trials, along with their open-label extension, and were presented at the European Academy of Dermatology and Venereology (EADV) Congress. The data indicate that the significant improvements observed in patients after one year of treatment with Bimzelx were sustained over a two-year period.

At the 96-week mark, 85.4% of patients administered Bimzelx achieved at least a 50% reduction from their baseline in the total abscess and inflammatory nodule count, with no increase in abscess or draining tunnel count (HiSCR50). Furthermore, 77.1% and 44.2% of patients reached HiSCR75 and HiSCR100, respectively. The improvements in disease severity, reductions in draining tunnel count, and enhancements in health-related quality of life were also maintained over the two years. Importantly, the drug was generally well tolerated, with no new safety concerns identified.

HS is an inflammatory skin condition affecting about 1% of the population in most studied regions. It results in the formation of nodules, abscesses, and draining tunnels that discharge pus. Many patients endure flare-ups and severe pain associated with the condition. Bimzelx works by selectively inhibiting IL-17A and IL-17F, two cytokines that play a crucial role in inflammatory processes. The drug has already received approval in the EU for treating HS, plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. In the US, it is approved for plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

Fiona du Monceau, UCB's executive vice president and head of patient evidence, remarked on the latest findings, stating: “In moderate-to-severe HS, healthcare professionals and patients value long-term data when they are making treatment decisions… This longer-term data builds on the 48-week results, demonstrating maintained response over two years, which is highly relevant for the HS community.”

Additionally, UCB presented positive four-year data for Bimzelx in treating moderate-to-severe plaque psoriasis at the EADV Congress. Du Monceau highlighted that these findings "demonstrate maintenance of complete skin clearance for patients continuing treatment with [the drug]."