SAFE-CGRP study: multicenter retrospective evaluation of the safety of CGRP pathway-targeting monoclonal antibodies in migraine with relevant comorbidities or conditions excluded from trials.

ABSTRACT:

Introduction

Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) have shown efficacy in the treatment of migraine. However, certain comorbidities have been excluded from clinical trials or may pose potential risks, despite not being formal contraindications. This study aimed to assess the safety of anti-CGRP or anti-CGRP receptor mAbs in real-world patients with such conditions.

Methods

A retrospective multicenter study was conducted across 11 headache units in Spain. Patients with relevant or trial-excluded comorbidities who received at least one anti-CGRP or anti-CGRP receptor mAb were included.

Results

Of 2,042 evaluated patients, 353 had at least one comorbidity. The mean treatment duration was 12.7 months [standard deviation (SD) = 8 mon

SUBMITTER: Sanabria-Gago C 

PROVIDER: S-EPMC12689294 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature