Spesolimab appears successful in hidradenitis suppurativa

Spesolimab was associated with decreased total count of hidradenitis suppurativa (HS) lesions in a proof-of-concept study. Moreover, the agent was well tolerated. According to the authors, the results of the current study support further investigation of spesolimab in patients with HS.

“Spesolimab is an IL-36 inhibitor and there is evidence that IL-36 agonists are overexpressed in HS, especially with respect to draining tunnels,” said Prof. Afsaneh Alavi (Mayo Clinic, MN, USA) [1,2]. Prof. Alavi presented the primary results of a proof-of-concept trial (NCT04762277) that randomised 52 patients with moderate-to-severe HS 2:1 to spesolimab or a placebo [2]. The participants in the active arm were continuously treated with spesolimab over 24 weeks: they received a loading dose of 1,200 mg spesolimab, intravenously administered at weeks 0, 1, and 2, followed by a maintenance dose of 1,200 mg subcutaneously every 2 weeks. The primary outcome was the percentage change from baseline in total abscess and inflammatory nodule count after 12 weeks of treatment.

“All lesion types were reduced after 12 weeks of treatment with spesolimab,” said Prof. Alavi. Though there was only a slight numerical advantage of spesolimab over placebo in the primary endpoint (-38.8% vs -34.7%). However, for example, the percentage change from baseline in drainage tunnel count favoured the spesolimab arm over the placebo arm (-40.1% vs +56.6%). The 12-week, open-label extension study also showed ongoing reductions in abscesses, inflammatory nodules, and draining tunnels with spesolimab.

The safety profile of spesolimab was favourable and in line with previous publications on this agent. Injection-site reactions, such as injection-site pain (8.3%) and injection-site erythema (11.1%), were the most common treatment-related adverse events in the spesolimab arm.

Prof. Alavi concluded that these results support further development of spesolimab in patients with HS.

1. Hessam S, et al. Br J Dermatol. 2018;178:761–767.
2. Alavi A, et al. Spesolimab for hidradenitis suppurativa: a proof-of-concept study. Session Acne, Hidradenitis Suppurativa, Rosacea 1, WCD 2023, 3–8 July, Singapore, Singapore.