• Richard B Lipton, Stewart J Tepper, Uwe Reuter, Stephen Silberstein, Walter F Stewart, Jon Nilsen, Dean K Leonardi, Pooja Desai, Sunfa Cheng, Daniel D Mikol, and Robert Lenz.
• From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA. Richard.Lipton@einstein.yu.edu.
• Neurology. 2019 May 7; 92 (19): e2250-e2260.

ObjectiveTo 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).MethodsIn 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).ResultsImprovements 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.ConclusionsErenumab-treated patients with CM experienced clinically relevant improvements across a broad range of patient-reported outcomes.Clinicaltrialsgov IdentifierNCT02066415.Classification Of EvidenceThis 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.

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