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Abstract Details

OnabotulinumtoxinA Treatment Improved Health-Related Quality of Life in Adults with Chronic Migraine: Results from a Prospective, Observational Study (PREDICT)
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-004
CM can adversely affect HRQOL and daily functioning, resulting in social and economic burden.
PREDICT aimed to assess real-world long-term health-related quality of life (HRQOL) in Canadian patients with chronic migraine (CM) treated with onabotulinumtoxinA.

Canadian, multicentre, prospective, observational study (NCT02502123) in adults naïve 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).

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<0.0001). Significant increases in MSQ post-Tx4 (restrictive: 21.5, preventive: 19.5, emotional: 22.9) and at the final visit (restrictive: 21.3, preventive: 19.2, emotional: 27.4) were observed versus baseline, exceeding minimal clinically important differences (all, p<0.0001). Following onabotulinumtoxinA treatment, most physicians rated their patients as improved (Tx4: 96.6%, final visit: 86.9%) and majority of patients were satisfied (range: 55.1% [Tx2] to 85.8% [Tx7]). 77 patients (41.8%) reported 168 treatment emergent adverse events (TEAEs), with 38 TEAEs in 22 patients (12.0%) considered treatment-related. 4 patients (2.2%) reported 6 serious TEAEs, none were considered treatment-related. No new safety signals were identified.

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.

Authors/Disclosures
Guy Boudreau
PRESENTER
No disclosure on file
Ian Finkelstein, MD (Trimedica Consulting) Dr. Finkelstein has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan. Dr. Finkelstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aralez. Dr. Finkelstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Finkelstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Finkelstein has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Finkelstein has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Finkelstein has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Finkelstein has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aralez. Dr. Finkelstein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Finkelstein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Finkelstein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aralez.
Corrie Graboski Corrie Graboski has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/AbbVie. Corrie Graboski has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Corrie Graboski has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NuvoPharm. Corrie Graboski has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan/AbbVie. Corrie Graboski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lily. Corrie Graboski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Corrie Graboski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for NuvoPharm. Corrie Graboski has received research support from Amgen/Novartis. The institution of Corrie Graboski has received research support from Allergan/Abbvie.
May Ong-Lam The institution of May Ong-Lam has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck .
Suzanne N. Christie, MD (Nepean Medical Centre) No disclosure on file
Katherine Sommer Katherine Sommer has received personal compensation for serving as an employee of AbbVie. Katherine Sommer has stock in AbbVie.
Meetu Bhogal, MSc (Allergan, Inc.) No disclosure on file
Goran Davidovic, MD No disclosure on file
Werner J. Becker, MD (Foothills Hospital) Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AbbVie. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for McKesson. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for University of Calgary.