Efficacy and safety of CGRP monoclonal antibodies in chronic migraine: a systematic review integrating randomized and real-world evidence
Abstract
Background and objectives: Chronic migraine (CM) is a highly disabling neurological disorder characterized by ≥ 15 headache days per month, of which at least 8 exhibit migrainous features. Despite the availability of preventive therapies, conventional treatments are often limited by suboptimal efficacy and poor tolerability. Monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor have emerged as mechanism-based preventive options. This systematic review aims to evaluate the efficacy, safety, and clinical relevance of CGRP-targeted monoclonal antibodies in the prevention of chronic migraine.
Materials and methods: A comprehensive literature search of PubMed, Scopus, and Web of Science was conducted from database inception to July 2025. Randomized controlled trials and observational real-world studies evaluating CGRP-targeted monoclonal antibodies in adult patients with chronic migraine were included. The review followed PRISMA 2020 guidelines (Page et al. 2021), was registered in the PROSPERO database (CRD420261284751), and included 11 studies out of 1,688 identified records.
Results: Across included studies, CGRP-targeted monoclonal antibodies consistently demonstrated reductions in migraine frequency, improvements in ≥ 50% responder rates, and favorable safety profiles. Randomized controlled trials showed robust efficacy compared with placebo, while real-world studies confirmed effectiveness in more heterogeneous and treatment-resistant…
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Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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