UCB has shared positive two-year results for its inflammatory disease drug Bimzelx (bimekizumab) in moderate-to-severe hidradenitis suppurativa (HS).
New data from the phase 3 BE HEARD I and BE HEARD II trials and their open-label extension, presented at this year’s European Academy of Dermatology and Venereology (EADV) Congress, showed that the clinically meaningful improvements observed with the drug at one year were maintained over two years.
At week 96, 85.4% of patients treated with Bimzelx achieved at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count (HiSCR50). HiSCR75 and HiSCR100, were achieved by 77.1% and 44.2% of patients, respectively.
Improvements in disease severity, reductions in draining tunnel count and improvements in health-related quality of life were also maintained over two years and the drug was generally well tolerated, with no new safety signals observed.
Estimated to affect about 1% of the population in most studied countries, HS is an inflammatory skin disease that causes nodules, abscesses and pus-discharging draining tunnels. Many patients experience flare-ups of the disease as well as severe pain.
Bimzelx is designed to selectively inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes, and is already approved in the EU to treat HS, as well as plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. The drug is also in the US for plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
Commenting on the latest results for the therapy, Fiona du Monceau, executive vice president, head of patient evidence at UCB, said: “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.”
Positive four-year data for Bimzelx in moderate-to-severe plaque psoriasis was also presented by the company at EADV, which du Monceau said “demonstrates maintenance of complete skin clearance for patients continuing treatment with [the drug]”.