Bimekizumab impact on draining tunnels: A dynamic assessment in patients with moderate to severe HS using pooled Week 48 results from BE HEARD I&II
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Keywords
bimekizumab, hidradenitis suppurativa
Abstract
Introduction: Hidradenitis suppurativa (HS) is a recurrent, inflammatory skin disease characterized by painful skin lesions in the folds of the skin and deep, dermal abscesses that join to form chronically draining tunnels (DTs).1,2 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits IL-17F in addition to IL-17A, both abundant in lesional skin.3,4 Here, we assess the effect of BKZ on DT outcomes over 48 weeks (wks) in BE HEARD I&II.5
Procedure/Study: Pooled data included an initial (Wks0–16) and maintenance (Wks16–48) treatment period. Randomization: 2:2:2:1 (initial/maintenance) to BKZ 320mg every 2 wks (Q2W)/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W or placebo (PBO)/BKZ Q2W. Proportions of patients with ≥1/≥3 DTs at baseline achieving 0, 1–2, 3–5 or >5 DTs were analyzed to Wk48 (observed case).
Results: Overall, 1,014 patients were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), BKZ Q4W/Q4W (N=288) or PBO/BKZ Q2W (N=146). At baseline, in patients with ≥1 DT, proportions with 1–2 DTs ranged from 34.2–37.4%; 3–5 DTs: 27.0–36.9%; >5 DTs: 28.8–35.5%. In patients with ≥3 DTs, proportions with 3–5 DTs ranged from 43.2–56.1%; >5 DTs: 43.9–56.8%.
At Wk16, higher proportions of BKZ-treated patients with ≥1 DT at baseline achieved 0 DTs vs PBO: BKZ Q2W/Q2W, 35.4%; BKZ Q2W/Q4W, 35.4%; BKZ Q4W/Q4W, 33.1% vs PBO, 24.7%. At Wk48, the proportions of patients receiving continuous BKZ that achieved 0 DTs increased to: 45.5%, 48.8%, and 46.8% respectively; PBO/BKZ Q2W switchers showed similar trends (46.3%). For patients with ≥3 DTs at baseline, at Wk16 a higher proportion receiving BKZ achieved 0 DTs vs PBO: BKZ Q2W/Q2W, 24.6%; BKZ Q2W/Q4W, 26.8%; BKZ Q4W/Q4W, 21.7%; vs PBO, 11.5%. At Wk48, the proportions receiving continuous BKZ that achieved 0 DTs increased to 35.0%, 42.2%, and 36.0%, respectively. PBO/BKZ Q2W switchers achieved similar levels (38.0%), with a more favorable increase from Wk16 to Wk48 than PBO/BKZ Q2W switchers with ≥1 DT at baseline.
Conclusion: At Wk16, a higher proportion of BKZ-treated vs PBO patients with ≥1/≥3 DTs at baseline achieved 0 or 1–2 DTs; proportions increased to Wk48 regardless of treatment arm.
References
2. Zouboulis CC. J Eur Acad Dermatol Venereol 2015;29:619–44;
3. Adams R. Front Immunol 2020;11:1894;
4. Krueger JG. Br J Dermatol 2024;190:149–52;
5. Kimball AB. Lancet 2024;403:2504–19.
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