Effect of fremanezumab on quality of life and productivity in patients with chronic migraine

Richard B Lipton, Joshua M Cohen, Sanjay K Gandhi, Ronghua Yang, Paul P Yeung, Dawn C Buse, Richard B Lipton, Joshua M Cohen, Sanjay K Gandhi, Ronghua Yang, Paul P Yeung, Dawn C Buse

Abstract

Objective: To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).

Methods: HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.

Results: The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all, p < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale (p < 0.05) and PGIC scores (p < 0.0001) as well as significant reductions from baseline in WPAI:GH scores (p < 0.01) and presenteeism (impairment while working; p < 0.05) vs placebo.

Conclusions: Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM.

Clinicaltrialsgov identifier: NCT02621931.

Classification of evidence: This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.

Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Figures

Figure 1. Patient flow
Figure 1. Patient flow
CM = chronic migraine; EM = episodic migraine; FAS = full analysis set.
Figure 2. Effect of fremanezumab on health-related…
Figure 2. Effect of fremanezumab on health-related quality of life as measured with the Migraine-Specific Quality of Life
(A) Role function–restrictive. (B) Role function–preventive. (C) Emotional function. LSM = least-squares mean.
Figure 3. Effect of fremanezumab on general…
Figure 3. Effect of fremanezumab on general health state as measured with the EuroQoL 5-dimension, 5-response level
LSM = least-squares mean.
Figure 4. Proportion of patients who reported…
Figure 4. Proportion of patients who reported Patient Global Impression of Change (PGIC) scores ≥5
PGIC ratings are based on a 7-point scale (1, no change; 2, almost the same; 3, a little better; 4, somewhat better; 5, moderately better; 6, better; 7, a great deal better).
Figure 5. Effect of fremanezumab on work…
Figure 5. Effect of fremanezumab on work productivity and activity impairment as measured with the Work Productivity and Activity Impairment: General Health
Overall work impairment, presenteeism, and absenteeism n values represent patients who were employed at week 12. Activity impairment n values represent full analysis set population. LSM = least-squares mean.

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Source: PubMed

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