PT  - JOURNAL ARTICLE
AU  - Lipton, Richard B.
AU  - Tepper, Stewart J.
AU  - Reuter, Uwe
AU  - Silberstein, Stephen
AU  - Stewart, Walter F.
AU  - Nilsen, Jon
AU  - Leonardi, Dean K.
AU  - Desai, Pooja
AU  - Cheng, Sunfa
AU  - Mikol, Daniel D.
AU  - Lenz, Robert
TI  - Erenumab in chronic migraine
AID  - 10.1212/WNL.0000000000007452
DP  - 2019 May 07
TA  - Neurology
PG  - e2250--e2260
VI  - 92
IP  - 19
4099  - http://n.neurology.org/content/92/19/e2250.short
4100  - http://n.neurology.org/content/92/19/e2250.full
SO  - Neurology2019 May 07; 92
AB  - 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.Clinicaltrials.gov identifier NCT02066415.Classification of evidence This study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.CGRP=calcitonin gene-related peptide; CI=confidence interval; CM=chronic migraine; EF=emotional functioning; HIT-6=Headache Impact Test–6; HRQoL=health-related quality of life; MID=minimally important difference; MIDAS=Migraine Disability Assessment; MMD=monthly migraine days; MSQ=Migraine-Specific Quality-of-Life Questionnaire; PREEMPT=Phase 3 Research Evaluating Migraine Prophylaxis Therapy; PRO=patient-reported outcome; PROMIS=Patient-Reported Outcomes Measurement Information System; RFP=role function-preventive; RFR=role function-restrictive