RT Journal Article
SR Electronic
T1 Erenumab in chronic migraine
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP e2250
OP e2260
DO 10.1212/WNL.0000000000007452
VO 92
IS 19
A1 Lipton, Richard B.
A1 Tepper, Stewart J.
A1 Reuter, Uwe
A1 Silberstein, Stephen
A1 Stewart, Walter F.
A1 Nilsen, Jon
A1 Leonardi, Dean K.
A1 Desai, Pooja
A1 Cheng, Sunfa
A1 Mikol, Daniel D.
A1 Lenz, Robert
YR 2019
UL http://n.neurology.org/content/92/19/e2250.abstract
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