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.
Highlights
Migraine is a common and often debilitating neurological disorder that is accompanied by a disabling primary headache with a plethora of transient somatosensory and motor disturbances [1,2,3]
Real-world studies and randomized clinical trials (RCTs); Articles in English or Spanish; Chronic and/or episodic migraine adult patients (18 years or older) who have received any migraine treatment with monoclonal antibodies for migraine; Articles with any of the following outcomes: monthly migraine days (MMD), monthly headache days (MHD), HIT-6, triptan days of use (TriD) and adverse events; Any monoclonal antibody against calcitonin generelated peptide (CGRP) and/or placebo will be accepted as comparisons
Systematic searches of the MEDLINE Embase, CENTRAL, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), Web of Science and Scopus databases will be conducted from their inception, following the PICO strategy, which included the following terms:
Summary
Migraine is a common and often debilitating neurological disorder that is accompanied by a disabling primary headache with a plethora of transient somatosensory and motor disturbances [1,2,3]. Real-world studies may raise flags and/or new data on monoclonal antibodies against CGRP that were rarely observed or not described in RCTs. The results of RCTs cannot be generalized to the general population due to strict eligibility criteria. By performing a real-world metanalysis, we can analyze the effect of monoclonal antibodies against CGRP in a larger population and draw more robust conclusions. The aim of this protocol for a multiple-treatment systematic review and meta-analysis is to synthesize all available RCT and real-world evidence on the effect and safety of CGRP monoclonal antibodies in patients with migraine to establish the differences between them in (1) MMD, (2) MHD, (3) HIT-6, (4) TriD and (5) adverse events
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