Abstract
Objective Analyse the real-world effectiveness and safety of 155U, 156–195U and 195U onabotulinumtoxinA in patients with chronic migraine (CM) from the PREDICT study.
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]). The primary endpoint was mean change from baseline in Migraine-Specific Quality of Life (MSQ) at Tx4. Headache days and physician and patient satisfaction were evaluated throughout. This analysis stratified the safety population (≥1 dose) into 3 groups (155U,156–195U and 195U) by the dose received on ≥3 of the first 4 treatment cycles.
Results 184 patients 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). All MSQ domains improved in all groups at Tx4 and at the final visit. Physicians rated most patients as improved, and most patients were satisfied at 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 155U, 41/65(63.1%) in 156–195U and 10/13(76.9%) in 195U; 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.
Conclusion Consistent with PREEMPT trials and REPOSE observational study, long-term treatment with onabotulinumtoxinA in PREDICT was safe, well-tolerated, and effective in CM. No new safety signals were identified.
