Fremanezumab for preventive treatment of migraine: Functional status on headache-free days.

Abstract

OBJECTIVE:

To evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies.

METHODS:

Functional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89).

RESULTS:

In patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all p < 0.005). An increased number of headache-free days with normal functional performance for some measures was also found in the CM group in those treated with fremanezumab.

CONCLUSION:

There was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s).

CLINICALTRIALSGOV IDENTIFIER:

NCT02025556 and NCT02021773.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that for patients with migraine, fremanezumab increases normal functional performance on headache-free days.

• Authors: Juliana VanderPluym, David W Dodick, Richard B Lipton, Yuju Ma, Pippa S Loupe, Marcelo E Bigal
• Journal: Neurology (Neurology) Vol. 91 Issue 12 Pg. e1152-e1165 (09 18 2018) ISSN: 1526-632X [Electronic] United States
• PMID: 30120138 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Chemical References

• Antibodies, Monoclonal
• fremanezumab

Topics

• Academic Performance
• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Clinical Trials, Phase II as Topic (statistics & numerical data)
• Drug Administration Schedule
• Fatigue (complications, drug therapy)
• Female
• Humans
• Male
• Medical Records
• Middle Aged
• Migraine Disorders (complications, drug therapy, prevention & control)
• Physical Functional Performance
• Prospective Studies
• Work Performance
• Young Adult