Spesolimab treatment for people with flares of generalized pustular psoriasis: a plain language summary of the Effisayil™ 1 study

What is this study about? Spesolimab is a drug developed to treat worsening disease (known as flares) of generalized pustular psoriasis (shortened to GPP). GPP is a rare disease in which pus-filled blisters or pustules suddenly form all over the body. Before a drug can be approved to treat the symptoms of a disease, clinical studies are performed to test how well it works and whether there are any side effects. This summary reports the results from a clinical study called Effisayil™ 1 that was performed to understand if spesolimab is effective at treating people with GPP flares. What were the results? The study showed that a single dose of spesolimab rapidly cleared pustules and skin lesions (areas of skin affected by redness, pustules, and scaling) within 1 week of treatment, and continued to improve skin lesions for up to 12 weeks. Spesolimab also reduced pain and improved the quality of life of participants over time. Some participants experienced side effects, which were mostly mild or moderate. What do the results of the study mean? The results indicate that spesolimab is an effective treatment for GPP flares. Although spesolimab is not yet available for doctors to prescribe as medication to their patients, the results of this study are currently under review by the official body that approves drugs for use in the USA. Clinical Trial Registration: NCT03782792 ( ClinicalTrials.gov )