Abstract
The PREDICT study assessed real-world, long-term health-related quality of life in adults with chronic migraine (CM) receiving onabotulinumtoxinA. Canadian, multicenter, prospective, observational study in adults naïve to onabotulinumtoxinA for CM. OnabotulinumtoxinA (155-195 U) was administered every 12 weeks over 2 years (≤7 treatment cycles). Primary endpoint: mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) at treatment 4 (Tx4) versus baseline. Secondary endpoints: mean change in MSQ at final visit versus baseline, and headache days. 184 participants (average age 45 years; 84.8% female; 94.6% Caucasian) received ≥1 onabotulinumtoxinA treatment; 150 participants completed 4 treatments (1 year) and 123 completed all 7 treatment cycles (2 years). Mean (SD) onabotulinumtoxinA dose per treatment cycle was 171 (18) U and treatment interval was 13.2 (1.8) weeks. Baseline mean (SD) 20.9 (6.7) headache days/month decreased (Tx1: -3.5 [6.3]; Tx4: -6.5 [6.6]; p < 0.0001 versus baseline). Mean (SD) increased from baseline in MSQ at Tx4 (restrictive: 21.5 [24.3], preventive: 19.5 [24.7], emotional: 22.9 [32.9]) and the final visit (restrictive: 21.3 [23.0], preventive: 19.2 [23.7], emotional: 27.4 [30.7]), exceeding minimal important differences (all p < 0.0001). Seventy-seven (41.8%) participants reported 168 treatment-emergent adverse events (TEAEs); 38 TEAEs (12.0%) were considered treatment-related. Four (2.2%) participants reported six serious TEAEs; none were considered treatment-related. No new safety signals were identified. Real-world evidence from PREDICT demonstrates that onabotulinumtoxinA for CM in Canada improved MSQ scores and reduced headache frequency and severity, adding to the body of evidence on the long-term safety and effectiveness of onabotulinumtoxinA for CM.
Highlights
Chronic migraine (CM) is a neurological disease defined by the International Classification of Headache Disorders, third edition (ICHD-3, beta version) as having fifteen or more headache days/month for more than three months over a twelve month period, with at least eight headaches per month fulfilling the criteria for migraine with or without aura.[1]
chronic migraine (CM) can adversely affect health-related quality of life and daily functioning,[4,5,6] resulting in social and economic burdens.[7,8]. This burden of illness is apparent in feedback provided by Migraine Canada as part of the Canadian Agency for Drugs and Technologies in Health process, where patient narratives and experiences were collected as part of a survey.[9]
Real-world evidence from PREDICT demonstrates that onabotulinumtoxinA for CM reduced headache day frequency and severity, improved health-related quality of life as determined by Migraine-Specific Quality of Life Questionnaire (MSQ), and was associated with high physician and patient satisfaction
Summary
Chronic migraine (CM) is a neurological disease defined by the International Classification of Headache Disorders, third edition (ICHD-3, beta version) as having fifteen or more headache days/month for more than three months over a twelve month period, with at least eight headaches per month fulfilling the criteria for migraine with or without aura.[1] In Canada, the prevalence of CM is estimated at 392,000 to 600,000 based on the global prevalence of 1.4%–2.2%.2,3 In comparison to those with episodic migraine, defined as
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