Bimekizumab Effect on the Need for Concomitant Rescue Interventions by HiSCR Response Level in Patients with Moderate to Severe Hidradenitis Suppurativa from BE HEARD I&II

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic, systemic, inflammatory skin disease characterized by deep, painful lesions that negatively impact patients’ (pts’) quality of life.¹ These lesions are difficult to treat and require multifaceted treatment, including the need for rescue interventions alongside conventional therapy.¹ Bimekizumab (BKZ) is a monoclonal IgG1 antibody that inhibits interleukin (IL)-17F in addition to IL-17A.² Here, the relationship between increasingly stringent HS Clinical Response (HiSCR) levels achieved with BKZ and the proportion of pts not requiring rescue concomitant interventions is investigated.
Procedure/Study: Pooled data are presented from the phase 3 BE HEARD I&II trials maintenance treatment period (Weeks [Wks]16–48).³ Pts were randomized 2:2:2:1 (initial/maintenance treatment period) to BKZ 320 mg every 2 wks (Q2W)/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W, or placebo (PBO)/BKZ Q2W. Data for the individual BKZ randomization arms and pooled across these arms (BKZ Total) are reported. BKZ-randomized pts were grouped by achievement of mutually exclusive HiSCR levels (<50% improvement from baseline [<HiSCR50]; HiSCR50–<75; HiSCR75–100) at Wk16. The incidence of pts not requiring any concomitant rescue interventions during the maintenance treatment period, including medical (antibiotics, analgesics) and procedural (incision/drainage, intralesional triamcinolone injection) interventions, are reported. Data reported as observed case.

Results: Overall, 868 pts were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), or BKZ Q4W/Q4W (N=288). In BKZ Total, 76.0%/83.2%/89.1% of pts in the HiSCR<50/50–<75/75–100 bands did not receive rescue intervention through Wks16–48, demonstrating a numerical increase with increasing HiSCR bands. Comparable trends across HiSCR<50/50–<75/75–100 bands were observed in pts receiving BKZ Q2W/Q2W (79.8%/90.0%/90.9%), BKZ Q2W/Q4W (75.0%/78.3%/89.0%) or BKZ Q4W/Q4W (73.3%/81.4%/87.1%). Similar trends were observed from the lowest to highest HiSCR bands when separating into any medical or procedural interventions.

Conclusion: Overall, the majority of BKZ-randomized pts did not require any concomitant rescue medical or procedural interventions through Wks16–48 and the proportions of these pts increased with increasingly stringent HiSCR bands. These data highlight the additional value to pts of a decreased need for concomitant rescue interventions when they achieve higher HiSCR response levels. 

References: 1. Zouboulis CC. J Eur Acad Dermatol Venereol 2015;29:619–44; 2. Adams R. Front Immunol 2020;11:1894; 3. Kimball AB. Lancet 2024;403:2504–19.