Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of chronic migraine (CM).

METHODS:

The Prevention of Migraine via Intravenous ALD403 Safety and Efficacy-2 (PROMISE-2) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with CM were randomly assigned to receive IV eptinezumab 100 mg, eptinezumab 300 mg, or placebo administered on day 0 and week 12. The primary endpoint was change from baseline in mean monthly migraine days (MMDs) over weeks 1 to 12.

RESULTS:

Among treated participants (n = 1,072), baseline mean number of MMDs was ≈16.1 across groups. Treatment with eptinezumab 100 and 300 mg was associated with significant reductions in MMDs across weeks 1 to 12 compared with placebo (placebo -5.6, 100 mg -7.7, p < 0.0001 vs placebo; 300 mg -8.2, p < 0.0001 vs placebo). Treatment-emergent adverse events (TEAEs) were reported by 43.5% (100 mg), 52.0% (300 mg), and 46.7% (placebo) of patients. Nasopharyngitis was the only TEAE reported for >2% of eptinezumab-treated patients at an incidence of >2% over placebo; it occurred in the 300 mg eptinezumab arm (eptinezumab 9.4%, placebo 6.0%).

CONCLUSION:

In patients with CM, eptinezumab 100 and 300 mg was associated with a significant reduction in MMDs from the day after IV administration through week 12, was well tolerated, and demonstrated an acceptable safety profile.

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that for patients with CM, a single dose of eptinezumab reduces MMDs over 12 weeks of treatment.

CLINICALTRIALSGOV IDENTIFIER:

NCT02974153.

• Authors: Richard B Lipton, Peter J Goadsby, Jeff Smith, Barbara A Schaeffler, David M Biondi, Joe Hirman, Susan Pederson, Brent Allan, Roger Cady
• Journal: Neurology (Neurology) Vol. 94 Issue 13 Pg. e1365-e1377 (03 31 2020) ISSN: 1526-632X [Electronic] United States
• PMID: 32209650 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Chemical References

• Antibodies, Monoclonal, Humanized
• eptinezumab

Topics

• Adult
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Chronic Disease (drug therapy)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Treatment Outcome