Analysis of Predefined Safety Events Across Spesolimab Trials in Dermatological and Non-Dermatological Conditions.

ABSTRACT:

Introduction

Spesolimab, a selective, humanised monoclonal antibody targeting the interleukin-36 receptor, is approved for the treatment of generalised pustular psoriasis (GPP). As a result of the limited patient numbers in GPP trials of spesolimab, analysing safety events across dermatological and non-dermatological diseases helps to further characterise the known safety profile of spesolimab. Here, we analyse predefined safety events from nine randomised, placebo-controlled spesolimab trials across dermatological (including GPP) and gastrointestinal conditions.

Methods

Predefined safety events were based on the known safety profile of spesolimab across all diseases investigated to date and potential risks of biological therapeutics, and included serious/severe/opportunisti

SUBMITTER: Gordon KB 

PROVIDER: S-EPMC11832866 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature