EADV News: Bimekizumab Achieves High Thresholds of Clinical Response in HS

The safety and efficacy of bimekizumab in HS have not been established, and it is not approved for use in HS by any regulatory authority worldwide. 

UCB’s Bimekizumab treatment results in clinically meaningful improvements in Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) and the more stringent HiSCR75, HiSCR90 and HiSCR100 compared with placebo at Week 16, with improvements increasing for patients remaining in the study through Week 48, according to research presented at the 2023 European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany.

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes. The safety and efficacy of bimekizumab in HS have not been established, and it is not approved for use in HS by any regulatory authority worldwide. 

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).1Adult 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):

• 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]).  
• 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.
• 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.
• According to the International Hidradenitis Suppurativa Severity Score System (IHS4), at baseline, 83.7–88.4% 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% vs. 15.3%). 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% had mild HS and 23.8–25.3% had moderate HS.
• 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.
• 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 ≥1 dose of bimekizumab were hidradenitis (18.7%), oral candidiasis (11.2%), and coronavirus infection (10.8%). Serious treatment emergent adverse events were reported in 7.0% Q4W/Q4W, 4.5% Q2W/Q4W and 8.1% Q2W/Q2W patients.

“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,” says 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, in a news release.  “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.”