Preprint Review Version 1 This version is not peer-reviewed

Cgrp Monoclonal Antibodies: Key Lessons from Real World Evidence

Version 1 : Received: 31 August 2024 / Approved: 2 September 2024 / Online: 2 September 2024 (13:38:30 CEST)

How to cite: Orlando, B.; Egeo, G.; Aurilia, C.; Fiorentini, G.; Barbanti, P. Cgrp Monoclonal Antibodies: Key Lessons from Real World Evidence. Preprints 2024, 2024090110. https://doi.org/10.20944/preprints202409.0110.v1 Orlando, B.; Egeo, G.; Aurilia, C.; Fiorentini, G.; Barbanti, P. Cgrp Monoclonal Antibodies: Key Lessons from Real World Evidence. Preprints 2024, 2024090110. https://doi.org/10.20944/preprints202409.0110.v1

Abstract

Abstract Background The advent of monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway has transformed the management of migraine, offering newfound optimism for clinicians and individuals with episodic migraine (EM) and chronic migraine (CM). While randomized controlled trials (RCTs) have provided crucial insights into the effectiveness and safety profiles of these treatments, their translation into real-world clinical practice remains a e challenge. Objective This review aims to conduct a comprehensive assessment of real-world studies, offering valuable insights tailored for practical application in clinical settings. Methods We conducted a comprehensive literature search in PubMed, SCOPUS, and MEDLINE for real-life studies on erenumab, fremanezumab, and galcanezumab. Abstracts underwent rigorous screening by two reviewers for relevance. Data extraction from selected articles was performed using a standardized form, with verification by a second reviewer. Data synthesis was narrative, following PRISMA guidelines. Results Our search included 55 pertinent studies conducted between 2019 and 2023. Real-world study designs demonstrated notable variability in the selection and inclusion of migraine patients, influenced by factors such as attack frequency, data collection criteria, and primary/secondary objectives. Key findings commonly reported considerable improvements in efficacy outcomes (migraine frequency, analgesic use, pain severity, disability), high responder rates, and optimal safety and tolerability profiles. Conclusion Real-world evidence underscores the role of anti-CGRP mAbs as targeted therapies for both CM and EM patients. The overall results indicate that the effectiveness and tolerability of anti-CGRP mAbs in real-world applications may exceed those observed in RCTs, an unprecedented finding in clinical neurology.

Keywords

migraine, anti-CGRP mAbs, treatment, real-life, disability

Subject

Medicine and Pharmacology, Neuroscience and Neurology

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