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.

Figure 1. Patient responses to questions concerning work/school/chore performance

(A) Work/school performance: I worked/studied normally. (B) Best describe your ability to perform household chores: I performed household chores normally. CM = chronic migraine; HFEM = high-frequency episodic migraine. *p < 0.05, **p < 0.01, ***p < 0.001.

Figure 2. Patient responses to questions on having difficulty in concentration and mental fatigue

(A) How much time did you feel that you were working more slowly or taking longer to complete a task? None of the time. (B) How much of the time yesterday did you find it difficult to concentrate on what you needed to do? None of the time. (C) On average, how much of the time yesterday were you very tired, asleep, or feeling drained? None of the time. CM = chronic migraine; HFEM = high-frequency episodic migraine. *p < 0.05, **p < 0.01, ***p < 0.001.