A systematic review, meta-analysis and meta-regression evaluating the adverse reactions to erenumab in the preventive treatment of migraine

ABSTRACT

Background: Erenumab has recently been approved as a pharmacological treatment for the prevention of migraine. However, the incidence estimates of adverse drug reactions (ADRs) were not consistent among studies. Consequently, pooled measures of the incidences of ADRs that accounts for inter-study heterogeneity are desirable. In addition, little is known on the factors leading to such heterogeneity.

Research design and methods: Clinical trials evaluating the occurrence of ADRs related to erenumab in migraine patients were searched with Ovid MEDLINE until April 2020. Random intercept models were used to estimate the pooled incidence of the ADRs reported at least in 5 different study populations. To examine whether specific factors correlated with the pooled incidence, we performed random-effects meta-regression.

Results: Of 138 retrieved references, 8 clinical trials were included in the meta-analysis. We observed a significant heterogeneity of the incidence estimates of back pain, influenza, nasopharyngitis, and upper respiratory tract infection (URTI). Most of the observed heterogeneity is ascribed to treatment duration for back pain (p = 0.045), influenza (p < 0.001) and URTI (p < 0.001), and significantly attributed to Body Mass Index (BMI) for nasopharyngitis (p < 0.001).

Conclusions: Back pain, influenza, nasopharyngitis and URTI showed a significant heterogeneity of incidence estimates.

KEYWORDS:

• CGRP
• CGRP receptor
• headache
• monoclonal antibody
• pain

Author contributions

LP, FMA and MS were involved in the conception and design of the study. All authors were involved in the collection, analysis and interpretation of data, in the drafting of the paper and its critical revision for intellectual content. All authors approved the final version of the manuscript and agree to be accountable for all aspects of the work.

Data availability statement

The data that support the findings of this study are available from the corresponding author (MS), upon reasonable request.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Declaration of interest

D Liang, M Andersen and M Sessa belong to the Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, supported by a grant from the Novo Nordisk Foundation (NNF15SA0018404). D Liang has been an employee (e.g., a student assistant) of Alcon and Novartis in the period 2017-2019. Currently, D Liang is employed by Alcon. M Andersen reports grants from Novartis, grants from Pfizer, grants from Janssen, grants from AstraZeneca, grants from H. Lundbeck & Mertz, grants from Novo Nordisk Foundation, outside the submitted work; and personal fees from Medicademy, the Danish Pharmaceutical Industry Association, for leading and teaching pharmacoepidemiology courses. FM Amin reports personal fees from Novartis, Eli Lilly and Teva. MM Al-Karagholi has acted as an invited speaker for Novartis and received travel grant from ElectroCore. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Supplemental Material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2021.1866537

Additional information

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.