New data demonstrate superiority of spesolimab vs placebo in preventing GPP

4 July 2023

German family-owned pharma major Boehringer Ingelheim today presented new late-breaking data from the EFFISAYIL trial showing that patients receiving the highest dose of spesolimab experienced significantly reduced generalized pustular psoriasis (GPP) flares by 84% over 48 weeks compared to placebo (hazard ratio 0.157; 95% confidence interval 0.05–0.54; p=0.0005).

Furthermore, the trial with 123 patients demonstrated no flares after week 4 of spesolimab treatment. The data were released at the 25th World Congress of Dermatology (WCD), now taking place in Singapore.

Under the trade name Spevigo, spesolimab was approved by the US Food and Drug Administration (FDA) last September for the treatment of GPP flares in adults. The drug was also granted a conditional marketing authorization by the European Medicines Agency’s (EMA) in December 2022. In total, it is now clelared in 40 countries, including Japan and China. GPP is a rare, life-threatening neutrophilic skin disease.

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