Erenumab in chronic migraine: Patient-reported outcomes in a randomized double-blind study

Abstract

Objective: To determine the effect of erenumab, a human monoclonal antibody targeting the calcitonin gene-related peptide receptor, on health-related quality of life (HRQoL), headache impact, and disability in patients with chronic migraine (CM).

Methods: In this double-blind, placebo-controlled study, 667 adults with CM were randomized (3:2:2) to placebo or erenumab (70 or 140 mg monthly). Exploratory endpoints included migraine-specific HRQoL (Migraine-Specific Quality-of-Life Questionnaire [MSQ]), headache impact (Headache Impact Test-6 [HIT-6]), migraine-related disability (Migraine Disability Assessment [MIDAS] test), and pain interference (Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference Scale short form 6b).

Results: Improvements were observed for all endpoints in both erenumab groups at month 3, with greater changes relative to placebo observed at month 1 for many outcomes. All 3 MSQ domains were improved from baseline with treatment differences for both doses exceeding minimally important differences established for MSQ-role function-restrictive (≥3.2) and MSQ-emotional functioning (≥7.5) and for MSQ-role function-preventive (≥4.5) for erenumab 140 mg. Changes from baseline in HIT-6 scores at month 3 were -5.6 for both doses vs -3.1 for placebo. MIDAS scores at month 3 improved by -19.4 days for 70 mg and -19.8 days for 140 mg vs -7.5 days for placebo. Individual-level minimally important difference was achieved by larger proportions of erenumab-treated participants than placebo for all MSQ domains and HIT-6. Lower proportions of erenumab-treated participants had MIDAS scores of severe (≥21) or very severe (≥41) or PROMIS scores ≥60 at month 3.

Conclusions: Erenumab-treated patients with CM experienced clinically relevant improvements across a broad range of patient-reported outcomes.

Clinicaltrialsgov identifier: NCT02066415.

Classification of evidence: This study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.

Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Figures

Figure 1. Change in Migraine-Specific Quality-of-Life Questionnaire (MSQ) scores from baseline over 3 months

Least-squares (LS) mean changes from baseline in (A) MSQ–role function-restrictive (MSQ-RFR), (B) MSQ–role function-preventive (MSQ-RFP), and (C) MSQ–emotional functioning (MSQ-EF) scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.05, except for MSQ-RFP at month 2: erenumab 70 mg, p = 0.051, and erenumab 140 mg, p = 0.061. MID = minimally important difference.

Figure 2. Change in Headache Impact Test–6 (HIT-6) total score from baseline over 3 months

Least-squares (LS) mean changes from baseline in HIT-6 scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.05. MID = minimally important difference.

Figure 3. Change in Migraine Disability Assessment (MIDAS) scores from baseline to month 3

Least-squares (LS) mean changes from baseline in (A) MIDAS total, (B) absenteeism, and (C) presenteeism scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.05.

Figure 4. Scatterplots of correlation between change in migraine days and change in patient-reported outcome scores

(A) Migraine-Specific Quality-of-Life Questionnaire–role function-restrictive (MSQ-RFR), (B) Migraine-Specific Quality-of-Life Questionnaire–role function-preventive (MSQ-RFP), (C) Migraine-Specific Quality-of-Life Questionnaire–emotional functioning (MSQ-EF), (D) Headache Impact Test–6 (HIT-6), and (E) Migraine Disability Assessment (MIDAS).

Figure 5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) scores from baseline over 3 months

Least-squares (LS) mean changes from baseline in PROMIS scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.01, except for erenumab 70 mg at month 1, p = 0.082.