Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials.

Abstract

INTRODUCTION:

Galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults. It is self-administered once monthly as a subcutaneous injection. This paper describes the time course of effect of galcanezumab in patients with episodic and chronic migraine.

METHODS:

Data were based on three double-blind, placebo-controlled, phase 3 studies. Patients (1773 episodic and 1113 chronic) were randomized (2:1:1) to monthly doses of placebo, galcanezumab 120 mg with a 240 mg loading dose, or galcanezumab 240 mg (January 2016-March 2017). Onset of effect was determined using a sequential analysis approach based on earliest time point at which galcanezumab achieved and subsequently maintained statistical superiority to placebo. Maintenance of effect was a comparison of the percentages of galcanezumab- and placebo-treated patients with maintenance of at least 50% response at the individual patient level. Cessation of effect was determined during a 4-month post-treatment period on the basis of change from baseline in monthly migraine headache days.

RESULTS:

Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine.

CONCLUSION:

Galcanezumab is a novel preventive therapeutic option for adult patients with migraine that has early onset of action, maintenance of effect, and gradual reduction of effect upon treatment cessation.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT02614183 (EVOLVE-1); NCT02614196 (EVOLVE-2); NCT02614261 (REGAIN).

• Authors: Dulanji K Kuruppu, James M North, Amy J Kovacik, Yan Dong, Eric M Pearlman, Susan L Hutchinson
• Journal: Advances in therapy (Adv Ther) Vol. 38 Issue 3 Pg. 1614-1626 (03 2021) ISSN: 1865-8652 [Electronic] United States
• PMID: 33544305 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)

Chemical References

• Antibodies, Monoclonal, Humanized
• galcanezumab
• Calcitonin Gene-Related Peptide

Topics

• Adult
• Antibodies, Monoclonal, Humanized
• Calcitonin Gene-Related Peptide
• Double-Blind Method
• Humans
• Migraine Disorders (drug therapy, prevention & control)
• Randomized Controlled Trials as Topic
• Treatment Outcome