Clinically meaningful efficacy outcomes observed at one year maintained to two years of treatment
By Elana Gotkine HealthDay Reporter
MONDAY, Oct. 7, 2024 (HealthDay News) — For patients with hidradenitis suppurativa (HS), bimekizumab is safe and efficacious over two years, according to a study presented at the annual meeting of the European Academy of Dermatology and Venereology, held from Sept. 25 to 28 in Amsterdam.
Christos C. Zouboulis, from the European Hidradenitis Suppurativa Foundation in Dessau, Germany, and colleagues presented efficacy and safety data over two years for the pooled BE HEARD I&II (BHI&II) and BE HEARD EXT (BHEXT) trials. Overall, 556 patients were randomly assigned to bimekizumab in BHI&II at baseline, completed 48 weeks, and entered BHEXT; 446 completed 96 weeks in BHEXT.
The researchers found that ≥50 percent HS Clinical Response (HiSCR50)/75/90/100 was achieved by 79.9, 64.0, 42.3, and 30.2 percent of all bimekizumab patients, respectively, at week 48; there was improvement in responses to 85.4, 77.1, 57.6, and 44.2 percent, respectively, at week 96. The mean International HS Severity Score System (IHS4) score among bimekizumab patients was 35.6 ± 31.5 at baseline; the mean percentage change from baseline in IHS4 was −70.3 ± 39.6 and −79.8 ± 28.1 percent at weeks 48 and 96, respectively. The mean draining tunnel (DT) count was 3.8 ± 4.3 among bimekizumab patients at baseline; the mean percentage change from baseline in DTs was −57.5 ± 72.9 and −73.7 ± 45.7 percent at weeks 48 and 96, respectively. Overall, 917 of 995 patients who received one or more doses of bimekizumab experienced a treatment-emergent adverse event (TEAE) over two years. Serious TEAEs were reported in 122 patients, and TEAEs leading to discontinuation were reported in 109.
“These findings are particularly encouraging given the need for new treatment options that offer sustained relief for patients,” Zouboulis said in a statement.
Several authors are employees of UCB Pharma, which manufactures bimekizumab and funded the BE HEARD trials.
Copyright © 2024 HealthDay. All rights reserved.
