Abstract Details

Title PREDICT: PREEMPT fixed-dose, fixed-site and follow the pain

Topic Headache

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 15-003

Objective To analyze the real-world effectiveness and safety of 155U, 156-195U and 195U onabotulinumtoxinA in patients with chronic migraine (CM) from the PREDICT study.

Background The phase 3 PREEMPT clinical trials established the safety and efficacy of 155-195U onabotulinumtoxinA in adults with CM.

Design/Methods PREDICT (NCT02502123) was a Canadian 2-year, prospective, observational study in adults with CM. Patients received onabotulinumtoxinA approximately every 12 weeks (≤7 treatment cycles [Tx]) per the Canadian product monograph. The primary endpoint was mean change from baseline in Migraine-Specific Quality of Life (MSQ) at Tx4. Headache days (daily headache diary), physician and patient satisfaction were evaluated throughout the study. This analysis stratified the safety population (≥1 onabotulinumtoxinA dose) into 3 groups (155U,156-195U and 195U) by the dose received on ≥3 of the first 4 treatment cycles.

Results Of 184 patients that received ≥1 onabotulinumtoxinA dose, 68 received 155U, 65 received 156-195U and 13 received 195U on ≥3 treatments. Baseline characteristics were similar between groups. Baseline mean (SD) headache days/month 21.6(6.4) 155U; 20(7) 156-195U; and 21.7(6) 195U decreased over time (Tx4: -7.1[6.7] 155U; -6.5[6.7] 156-195U; -11.2[6.4] 195U versus baseline). Improvements in all MSQ domains were observed across groups at Tx4 and the final visit. Physicians rated most patients as improved, and the majority of patients were satisfied at the final visit (80.8% 155U; 83.6% 156-195U; 90% 195U). Treatment-emergent adverse events (TEAEs) were reported in 18/68 patients (26.5%) in the 155U group, 41/65 (63.1%) in the 156-195U group and 10/13 (76.9%) in the 195U group; treatment-related TEAEs were 9(13.2%), 10(15.4%) and 3(23.1%) respectively; serious TEAEs were 0, 3(4.6%) and 1(7.7%), none were considered treatment-related.

Conclusions Consistent with the PREEMPT clinical trials and the REPOSE observational study, long-term treatment with 155U, 156-195U, and 195U onabotulinumtoxinA in PREDICT was safe, generally well-tolerated, and effective in the treatment of CM. No new safety signals were identified.

Authors/Disclosures
Katherine Sommer PRESENTER	Katherine Sommer has received personal compensation for serving as an employee of AbbVie. Katherine Sommer has stock in AbbVie.
	No disclosure on file
	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 AAN interests or activities. Dr. Becker has a non-compensated relationship as a Board Member with Pain Society of Alberta that is relevant to AAN interests or activities.
	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.

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