Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest T. Nie is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.
Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.
Additional information about this Adis Drug Review can be found here.
Abstract
Spesolimab (Spevigo®) is a promising new treatment for generalised pustular psoriasis (GPP) flares. GPP is a rare and life-threatening autoinflammatory disease characterized by flares of widespread skin lesions with pustules, which may be accompanied by systemic inflammation. Spesolimab, a novel interleukin (IL)-36 receptor antagonist, is approved in the EU and USA for the treatment of GPP flares in adults. In a pivotal phase 2 trial, a significantly higher proportion of patients with a GPP flare who received a single intravenous dose of spesolimab had no visible pustules and clear or almost clear skin at the end of week 1 compared with placebo. These responses were sustained to 12 weeks. Spesolimab was generally well tolerated, with low incidences of the most common treatment-emergent adverse events. However, spesolimab may increase the risk of infections and may be associated with hypersensitivity and infusion-related reactions.