Effect of fremanezumab on quality of life and productivity in patients with chronic migraine
Open Access
- 18 August 2020
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Neurology
- Vol. 95 (7), e878-e888
- https://doi.org/10.1212/wnl.0000000000010000
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. ClinicalTrials.gov 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.This publication has 47 references indexed in Scilit:
- The psychometric properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) in chronic migraine patientsQuality of Life Research, 2012
- Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adultsNeurology, 2012
- Validating Migraine‐Specific Quality of Life Questionnaire v2.1 in Episodic and Chronic MigraineHeadache: The Journal of Head and Face Pain, 2011
- Cost of Health Care Among Patients With Chronic and Episodic Migraine in Canada and the USA: Results From the International Burden of Migraine Study (IBMS)Headache: The Journal of Head and Face Pain, 2011
- Medication Adherence: WHO Cares?Mayo Clinic Proceedings, 2011
- Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)Quality of Life Research, 2011
- OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trialCephalalgia, 2010
- OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trialCephalalgia, 2010
- The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF)The Journal of Headache and Pain, 2005
- The Validity and Reproducibility of a Work Productivity and Activity Impairment InstrumentPharmacoEconomics, 1993