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CGRP Targeting Therapy for Chronic Migraine—Evidence from Clinical Trials and Real-world Studies

  • Chronic Daily Headache (SJ Wang and SP Chen, Section Editors)
  • Published:
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Abstract

Purpose of Review

Monoclonal antibodies against calcitonin gene-related peptide (CGRP) or its receptor have become part of the standard treatment for migraine in clinical practice. The current review focuses on the clinical evidence of CGRP monoclonal antibodies in patients with chronic migraine (CM), including more challenging cases.

Recent Findings

CGRP monoclonal antibodies were more effective than placebo in reducing the number of monthly migraine days (MMDs), and the change relative to placebo in the treatment group was between − 1.2 and − 2.7 days at 3 months. CGRP monoclonal antibodies resulted in ≥ 50% response in 27.5 to 61.4% of patients, and doubled the odds for having ≥ 50% response. The findings were generally consistent in patients with coexisting medication overuse or with treatment failures to multiple preventive medications, including onabotulinumtoxinA. The results from real-world studies (RWS) were similar to those seen in clinical trials, and the changes from baseline in the number of MMDs and the response rates largely fell within the ranges of those reported in the treatment group in pivotal trials. The therapeutic effects typically started within a few days, and remained steady after regular treatment for up to 1 year. These agents were generally well tolerated, and the discontinuation rates due to adverse events in clinical trials and in many RWS were < 4.5%.

Summary

CGRP monoclonal antibodies are effective and safe in the treatment of patients with CM, including clinical challenging cases. However, the role of CGRP monoclonal antibodies in a number of conditions, such as cardiovascular or cerebrovascular diseases, pregnancy, and overuse of opioids or barbiturates, needs to be further clarified.

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Correspondence to Yen-Feng Wang.

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Conflict of Interest

This review was sponsored in part by Taiwan Ministry of Science and Technology [MOST 109–2314-B-075 -054 and MOST 110–2314-B-075 -041 -MY3 (to YFW), and MOST 104–2314-B-010–015-MY2, MOST106-2321-B-010–009, MOST 107–2321-B-010–001, MOST 108–2321-B-010–014 -MY2, 108–2321-B-010 001, MOST 108–2314-B-010–023-MY3, and MOST-110–2321-B-010–005 (to SJW)]; and Taipei Veterans General Hospital [VGH 108-C-092, VGH 109-C-096, and VGH 110-C-111 (to YFW)]; this work was also supported by the Brain Research Center, National Yang Ming Chiao Tung University from The Featured Areas Research Center Program within the framework of the Higher Education Sprout Project by the Ministry of Education (MOE) in Taiwan. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

YFW has received honoraria as a speaker from Taiwan branches of Allergan/AbbVie, Eli Lilly, Novartis, Pfizer, Sanofi, UCB, and Viatris, and Orient EuroPharma. He has received research grants from the Taiwan Ministry of Science and Technology, and Taipei Veterans General Hospital. SJW has served on the advisory boards of Daiichi-Sankyo, Eli Lilly and Novartis; has received honoraria as a moderator from Allergan/AbbVie, Pfizer, Eli Lilly, Biogen and Eisai and has been the PI in trials sponsored by Eli Lilly, Novartis, and Allergan/AbbVie. He has received research grants from the Taiwan Minister of Technology and Science (MOST), Brain Research Center, National Yang Ming Chiao Tung University from The Featured Areas Research Center Program within the framework of the Higher Education Sprout Project by the Ministry of Education (MOE) in Taiwan, Taipei Veterans General Hospital, Taiwan Headache Society and Taiwan branches of Eli Lilly, Novartis, and Pfizer.

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Wang, YF., Wang, SJ. CGRP Targeting Therapy for Chronic Migraine—Evidence from Clinical Trials and Real-world Studies. Curr Pain Headache Rep 26, 543–554 (2022). https://doi.org/10.1007/s11916-022-01056-4

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