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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
PREDICT aimed to assess real-world long-term health-related quality of life (HRQOL) in Canadian patients with chronic migraine (CM) treated with onabotulinumtoxinA.
CM can adversely affect HRQOL and daily functioning, resulting in social and economic burden.

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

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.
No disclosure on file
No disclosure on file
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 $500-$4,999 for serving as a Consultant for AbbVie. Dr. Becker has received personal compensation in the range of $5,000-$9,999 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 Teva. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving as a Discussion moderator / speaker with Pfizer. Dr. Becker has a non-compensated relationship as a Board Member with Migraine Canada that is relevant to Â鶹´«Ã½Ó³»­ interests or activities. Dr. Becker has a non-compensated relationship as a Board Member with Pain Society of Alberta that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.