Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study.

ABSTRACT:

Introduction

Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections.

Methods and analysis

BRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Ita

SUBMITTER: Reilev M 

PROVIDER: S-EPMC9896233 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature