UCB presents positive phase 3 results for bimekizumab in hidradenitis suppurativa
16 Feb 2024
Clinical ResultPhase 3Drug Approval
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Source: PMLiVE
UCB's bimekizumab has demonstrated sustained efficacy and symptom improvement in patients with hidradenitis suppurativa (HS), according to late-stage results presented at this year’s Conference of the European Hidradenitis Suppurativa Foundation (EHSF).
An estimated 1% of the population in most studied countries is affected by HS, an inflammatory skin disease that causes boil-like abscesses and irreversible scarring. Many patients experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.
UCB’s bimekizumab is designed to selectively inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes. The drug is already approved in the EU under the trade name Bimzelx to treat plaque psoriasis, psoriatic arthritis and axial spondyloarthritis, but is not yet approved for use in HS by any regulatory authority worldwide.
Data from the phase 3 BE HEARD I and BE HEARD II studies presented at EHSF showed that bimekizumab was associated with statistically significant and clinically meaningful improvements over placebo in the signs and symptoms of adults with moderate-to-severe HS at week 16, which were maintained until week 48.
At week 16, 51.1 to 62.9% of bimekizumab-treated patients achieved at least a 55% improvement from baseline on the international HS severity score system (IHS4), compared with 25.7 to 30.8% of patients receiving placebo. These responses were sustained or increased by week 48, and those who switched from placebo to bimekizumab achieved responses comparable to those receiving continuous treatment with the drug.
Additionally, a greater proportion of patients achieved IHS4 score improvements of 75% or 90% with bimekizumab treatment versus placebo.
Bimekizumab also demonstrated improvements in overall lesion count and lesion clearance across abscesses, inflammatory nodules and draining tunnels over 48 weeks, UCB said, and patient-reported data showed that high levels of clinical responses observed with bimekizumab treatment translated into health-related quality of life benefits.
Emmanuel Caeymaex, executive vice president, immunology solutions, and head of US at UCB, said the results presented at EHSF "build on the phase 3 data communicated to date and reinforce [the company’s] belief in the potential of bimekizumab to make a meaningful difference to patients”.
“[The] results presented reaffirm the high levels of sustained clinical response achieved with bimekizumab treatment, the positive impact on health-related quality of life as reported by patients, and the importance of timely treatment following diagnosis,” he said.
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