The Safety and Efficacy of Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies for the Preventive Treatment of Migraine: A Protocol for Multiple-Treatment Systematic Review and Meta-Analysis

Abstract

Background: Migraine is a common and disabling primary headache disorder, associated with many medical comorbidities, highly prevalent, with complex treatment and management. Currently, monoclonal antibodies targeting the trigeminal sensory neuropeptide, calcitonin gene-related peptide (CGRP), are available. The aim of this protocol is to provide a review comparing the effects and safety profile of different monoclonal antibodies in migraine patients. Methods: The literature search will be performed through the MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), Web of Science and Scopus databases, following the PICO strategy. Real World studies and randomized clinical trials assessing the effect of monoclonal antibodies against CGRP interventions (erenumab, eptinezumab, fremanezumab and galcanezumab) on monthly migraine days (MMD), monthly headache days (MHD), headache impact test (HIT-6) and triptan days of use (TriD) will be included. In Real World studies, the DerSimonian and Laird method will be used to calculate pooled estimates of the mean change difference and in randomized clinical trials, a network meta-analysis will be performed to estimate the comparative effects of different monoclonal antibodies against CGRP. Results: The findings of this study will be reported in a peer-reviewed journal. Conclusions: This study will provide evidence to health professionals on the efficacy and safety of different monoclonal antibodies against CGRP on the outcomes studied.

Efficacy and Safety of Anti-calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies in Preventing Migraines: A Systematic Review

“…The findings of this study also show their long-term safety, making them a valuable option for migraine prevention. Fernández-Bravo-Rodrigo et al (2022) also revised a similar study and supported the findings of Vandervorst et al (2021) [ 15 , 6 ]. This study utilizes meta-analytical methods to provide comprehensive evidence on the efficacy and safety of different CGRP monoclonal antibodies for the treatment of migraine [ 39 ].…”

“…It has also been shown to be well-tolerated, with few adverse effects [ 14 ]. Fremanezumab and galcanezumab are humanized monoclonal antibodies that target CGRP itself [ 15 ]. Clinical trials have shown that these drugs reduce the number of patients suffering from migraines by up to 50% or more in approximately 50%-60% of individuals with migraines [ 16 ].…”

“…Clinical trials have shown that these drugs reduce the number of patients suffering from migraines by up to 50% or more in approximately 50%-60% of individuals with migraines [ 16 ]. They have also been shown to be well-tolerated, with few adverse effects [ 15 ].…”

Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review

“…Finally, there are no data about head-to-head comparison between distinct anti-CGRP mAb, so primary studies will also be needed to improve the evidence-based data. During the elaboration of this review, a protocol to perform a systematic review and meta-analysis comparing the effects and safety profile of different monoclonal antibodies in migraine patients has been published, meaning that this issue is getting increasing interest from researchers to create evidence for clinical practice recommendations although these studies, in particular, do not target solely resistant chronic migraine [ 87 ].…”