Abstract text (incl. figure legends and references)

Objective:To analyze the real-world effectiveness and safety of 155U, 156-195U and 195U onabotulinumtoxinA (onabotA) in patients with chronic migraine (CM) from the PREDICT study. The phase 3 PREEMPT clinical trials established the safety and efficacy of 155-195U onabotA in adults with CM.

Methods:PREDICT (NCT02502123) was a Canadian 2-year, prospective, observational study in adults with CM. Patients received onabotA 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 onabotA dose) into 3 groups (155U,156-195U and 195U) by the dose receivedon ≥3 of the first 4 treatment cycles.

Results:Of 184 patients that received ≥1 onabotA 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%), and not treatment-related.

Conclusion:Long-term treatment with 155U, 156-195U, and 195U onabotA in PREDICT was safe, well-tolerated, and effective in the treatment of CM. No new safety signals were identified.