Phase III data analysis presented at EADV 2023 showed bimekizumab achieved high thresholds of clinical response in hidradenitis suppurativa.- UCB

These analyses are among bimekizumab data in HS presented across three oral presentations and several posters at the 2023 European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany, October 11–14.

“Patients with hidradenitis suppurativa live with one of the most burdensome chronic systemic skin diseases. There is a compelling need for new treatment options that can offer high and durable clinical response,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “Data presented at EADV showed that over 48 weeks many patients treated with bimekizumab achieved high thresholds of response. These findings suggest that inhibition of IL-17F in addition to IL-17A represents a promising treatment approach in moderate to severe hidradenitis suppurativa.”

“The bimekizumab Phase III clinical trial program in hidradenitis suppurativa included the more stringent clinical outcomes of HiSCR75, HiSCR90 and HiSCR100 in addition to the standard HiSCR50. In these studies, bimekizumab demonstrated clinical meaningful improvements for these outcomes over placebo at Week 16, with improvements increasing for patients remaining in the studies through Week 48. In addition, improvements in disease severity were seen over time, with the majority of patients with severe hidradenitis suppurativa at baseline shifting to mild to moderate disease according to the IHS4 dynamic classification system,” said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany.

Data were pooled from the BE HEARD I and II studies , which included an initial (Weeks 0–16) and maintenance treatment period (Weeks 16–48). Adult patients (n=1,014) were randomized 2:2:2:1 (initial/maintenance) to receive, either bimekizumab 320 mg every two weeks (Q2W) /Q2W (n=288); bimekizumab Q2W/every four weeks (Q4W); n=292; bimekizumab Q4W/Q4W (n=288) or placebo/bimekizumab Q2W (n=146).

Highlights from the pooled data analysis (BE HEARD I and BE HEARD II) : i. Bimekizumab-treated patients showed higher response rates in the primary endpoint (HiSCR50) at Week 16 vs. placebo (58 percent Q2W/Q2W, 55.9 percent Q2W/Q4W, 56.1 percent Q4W/Q4W vs. 33.4 percent for placebo).Improvements increased for patients through Week 48 with almost 8 in 10 achieving HiSCR50. At Week 48, the response in patients who switched from placebo to bimekizumab at Week 16 approached that reached by patients on bimekizumab from baseline (70.5 percent [n=74/105]). ii. A similar trend was seen in the more stringent HiSCR75 and HiSCR90 endpoints through Week 48. Bimekizumab-treated patients had improved responses at Week 48 with approximately 6 in 10 patients achieving HiSCR75. Analysis of the most stringent endpoint, HiSCR100, showed numerically higher responses in bimekizumab patients vs. placebo at Week 16, and improved responses at Week 48 with approximately 3 out of 10 patients achieving HiSCR100. Patients who switched from placebo to bimekizumab at Week 16 demonstrated a similar trend in HiSCR100 rates at Week 48. iii. Across all bimekizumab treatment groups, over 8 out of 10 patients who achieved HiSCR50 at Week 16 (n=160 Q2W/Q2W; n=155 Q2W/Q4W; n=152 Q4W/Q4W), maintained the response through Week 48. In addition, across all bimekizumab treatment groups, more than 8 out of 10 patients who achieved an abscess and inflammatory nodule (AN) count of 0,1 or 2 at Week 16 (n=104 Q2W/Q2W, n=99 Q2W/Q4W; n=87 Q4W/Q4W) maintained this response to Week 48. iv. According to the International Hidradenitis Suppurativa Severity Score System (IHS4), at baseline, 83.7–88.4 percent of the enrolled patients across bimekizumab dosing regimens had severe HS. A post hoc analysis showed that at Week 16 higher proportions of bimekizumab-treated patients had mild HS vs. placebo (24.6¬–27.2 percent vs. 15.3 percent). Similar trends were observed for patients with moderate HS (25.8–28.0 percent vs. 17.1 percent). Improvements in IHS4 categories were sustained over time across bimekizumab groups. At Week 48, 37.3–40.1 percent had mild HS and 23.8–25.3 percent had moderate HS. v. Analyses showed that regardless of weight and body mass index category, a higher proportion of patients treated with bimekizumab vs. placebo achieved clinical response at Week 16 (HiSCR50, HiSCR75 and HiSCR90) with increasing levels of response between Week 16 and Week 48. vi. The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous studies with no new safety signals observed. The most frequently reported TEAEs in 995 patients receiving greater than 1 dose of bimekizumab were hidradenitis (18.7 percent), oral candidiasis (11.2 percent), and coronavirus infection (10.8 percent). Serious treatment emergent adverse events were reported in 7.0 percent Q4W/Q4W, 4.5 percent Q2W/Q4W and 8.1 percent Q2W/Q2W patients.

About BE HEARD I and BE HEARD II: BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase III studies designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS). The two studies had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS. The primary endpoint in both studies was HiSCR50 at Week 16. A key secondary endpoint was HiSCR75 at Week 16. HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.