OnabotulinumtoxinA Treatment Improved Health-Related Quality of Life in Adults with Chronic Migraine: Results from a Prospective, Observational Study (PREDICT) (714)

2020 
Objective: PREDICT aimed to assess real-world long-term health-related quality of life (HRQOL) in Canadian patients with chronic migraine (CM) treated with onabotulinumtoxinA. Background: CM can adversely affect HRQOL and daily functioning, resulting in social and economic burden. Design/Methods: Canadian, multicentre, prospective, observational study (NCT02502123) in adults naive to botulinum toxin(s) for CM. OnabotulinumtoxinA was administered ≤7 treatment cycles per the Canadian product monograph. Primary endpoint: mean change in Migraine-Specific Quality of Life (MSQ) at Tx4 vs. baseline. Secondary endpoints: mean change in MSQ at final visit vs. baseline, onabotulinumtoxinA treatment utilization (each session), headache days (daily headache diary), and physician (baseline, Tx4, and final visit)/patient (each session) satisfaction. Unless noted, data presented as mean(SD). Results: 184 participants (average 45 years, predominantly female [84.8%] and Caucasian [94.6%]) received ≥1 treatment with onabotulinumtoxinA. Mean dose of onabotulinumtoxinA per treatment cycle was 171(18) U; treatment interval 13.2(1.8) weeks. At baseline, patients reported 20.9(6.7) headache days/month, which decreased over time (range: −3.5[6.3] at Tx1 to −6.3[7.3] at Tx7; all timepoints versus baseline, p Conclusions: Real-world data from PREDICT demonstrate that onabotulinumtoxinA treatment for CM reduced headache days and improved HRQOL, with high physician and patient satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for CM. Disclosure: Dr. Boudreau has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Allergan, Teva, Lilly. Dr. Boudreau has received research support from Lilly.Dr. Finkelstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Teva, Lilly, Aralez, Nuvo. Dr. Graboski has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Aralez, Amgen/Novartis, and Lilly. Dr. Graboski has received research support from Allergan and Amgen/Novartis. Dr. Ong-Lam has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Cannimed and Spectrum Canada. Dr. Christie has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly, Novartis, Allergan, Teva. Dr. Christie has received research support from Novartis. Dr. Sommer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Allergan. Dr. Sommer holds stock and/or stock options in Katherine Sommer, MRes, PhD, is an employee of Allergan plc and receives stock or stock options. which sponsored research in which Dr. Sommer was involved as an investigator. Dr. Sommer holds stock and/or stock options in Employee of Allergan and receives stock options. Dr. Bhogal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Allergan. Dr. Davidovic has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Becker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Weber and Weber.
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