Bimekizumab cumulative clinical benefit in patients with moderate to severe hidradenitis suppurativa through 1 year of the BE HEARD I&II phase 3 trials

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease which significantly impacts health-related quality of life.1 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.2 ere, the cumulative benefit of BKZ treatment on HS clinical response (HiSCR) through 16 and 48 weeks (wks) is reported using area under the curve (AUC) analyses.Procedure/study: Pooled data from BE HEARD I&II included an initial (Wks0–16) and maintenance treatment period (Wks16–48).3 Randomization: 2:2:2:1 (initial/maintenance) BKZ 320mg every 2 wks (Q2W)/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W, or placebo (PBO)/BKZ Q2W. HiSCR50/75/90 response was achieved at a given visit if there was ≥50/75/90% reduction in the total abscess/inflammatory nodule count with no increase from baseline in abscess or draining tunnel count. Cumulative clinical benefit estimation: total AUC through Wk48 for HiSCR50/75/90 achievers. Calculation of estimated number of days patients achieved each response: proportion of total possible AUC for each outcome multiplied by total number of days in the period (Wks0–16: 112 days, Wks0–48: 336). Data are reported as observed case, where N represents number of patients with a non-missing lesion count assessment in the given week, and percentages are calculated accordingly (i.e. where data recorded after an intercurrent event are included).Results: Overall, 1,014 patients were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), BKZ Q4W/Q4W (N=288) and PBO/BKZ Q2W (N=146). Through 16wks, the total number of days patients achieved HiSCR50 was almost double in BKZ Q2W/Q2W (47 days), BKZ Q2W/Q4W (49), and BKZ Q4W/Q4W (47) groups vs PBO (27). To Wk16, the total number of days patients achieved HiSCR75/90 was at least double in the BKZ groups vs PBO. To Wk48, total number of days with HiSCR50 achievement: BKZ Q2W/Q2W, 211; BKZ Q2W/Q4W, 212; BKZ Q4W/Q4W, 206 vs PBO/BKZ Q2W, 178. Comparable results were observed for HiSCR75/90 at Wk48, with BKZ groups maintaining higher responses vs PBO. Conclusion: High levels of cumulative clinical benefit were observed for patients on BKZ through Wk16; benefits increased substantially through Wk48. The cumulative benefit of BKZ through 48wks was evident for patients receiving continuous BKZ and PBO switchers. The total number of days of clinical outcome achievement remained higher in those on continuous BKZ vs PBO switchers. These results demonstrate the rapid, high-level and durable responses that can be obtained with BKZ.