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Spesolimab in generalised pustular psoriasis flares: a profile of its use

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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.

Plain Language Summary

Generalised pustular psoriasis (GPP) is a rare and life-threatening inflammatory skin disease. It is characterized by widespread rashes with pustules and may occur with or without systemic inflammation. Rapid treatment of a GPP flare is important; however, previous therapy options were based on limited evidence and were often slow to clear flares. Spesolimab (Spevigo®) is an interleukin (IL)-36 antagonist that targets the underlying inflammatory pathway in GPP. It is administered as a single intravenous dose and is approved in the EU and USA for the treatment of adults with a GPP flare. In a phase 2 clinical trial in patients experiencing a GPP flare, more patients who received spesolimab had no visible pustules and clear or almost clear skin at the end of 1 week compared with those who received placebo. Responses were maintained to 12 weeks. Spesolimab was generally well tolerated; however, it may increase the risk of infections and may be associated with hypersensitivity and infusion-related reactions. In conclusion, spesolimab is a promising new treatment for GPP flares in adults.

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Acknowledgements

The manuscript was reviewed by: L. Puig, Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; W-H. Wang, Department of Dermatology, Peking University Third Hospital, Beijing, China. During the peer review process, Boehringer Ingelheim International GmbH, the marketing authorization holder of spesolimab, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Tina Nie

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Correspondence to Tina Nie.

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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.

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Nie, T. Spesolimab in generalised pustular psoriasis flares: a profile of its use. Drugs Ther Perspect 39, 404–412 (2023). https://doi.org/10.1007/s40267-023-01034-9

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