scholarly journals Psychometric Validation of the Role Function Restrictive Domain of the Migraine Specific Quality‐of‐Life Questionnaire Version 2.1 Electronic Patient‐Reported Outcome in Patients With Episodic and Chronic Migraine

2019 ◽  
Vol 59 (5) ◽  
pp. 756-774 ◽  
Author(s):  
Rebecca M. Speck ◽  
Huda Shalhoub ◽  
Kathleen W. Wyrwich ◽  
Ren Yu ◽  
David W. Ayer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Patient Reported Outcome ◽  
Psychometric Validation ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Role Function ◽  
Patient Reported ◽  
Questionnaire Version

scholarly journals Erenumab in chronic migraine

Neurology ◽  
2019 ◽  
Vol 92 (19) ◽  
pp. e2250-e2260 ◽  
Author(s):  
Richard B. Lipton ◽  
Stewart J. Tepper ◽  
Uwe Reuter ◽  
Stephen Silberstein ◽  
Walter F. Stewart ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Role Function ◽  
Patient Reported ◽  
Headache Impact

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.Clinicaltrials.gov identifierNCT02066415.Classification of evidenceThis study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.

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