Post-hoc analysis of pooled data from the 24-week, placebo-controlled, randomized, double-blind PREEMPT trials (NCT00156910, NCT00168428) and single-arm, open-label, 108-week COMPEL (NCT01516892) study. Percentages of participants meeting responder status at 24, 48, or 108 weeks for clinically meaningful changes in headache days (≥50% reduction in headache-day frequency), Headache Impact Test (HIT-6; ≥5-point improvement), Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive (MSQ-RFR; ≥10.9-point improvement in standardized MSQ score), and either Average Daily Headache Severity (ADHS; ≥1-point improvement; PREEMPT) or Migraine Disability Assessment Scale (MIDAS; ≥5-point improvement; COMPEL) were calculated. Percentages of participants meeting responder status in ≥1 to all 4 responder criteria were calculated.

Participants (N=1384) were randomized to onabotulinumtoxinA (n=688) or placebo (n=696) in PREEMPT; 716 participants were enrolled in COMPEL. In PREEMPT, significantly greater proportions of participants treated with onabotulinumtoxinA compared with placebo met responder criteria for change in headache days (44.8% vs 34.2%), HIT-6 (40.8% vs 25.3%), MSQ-RFR (59.0% vs 40.2%), and ADHS (35.5% vs 22.4%) scores at 24 weeks (all P<0.001). At least 1 of these domains was met by 72.1% and 56.6% of PREEMPT participants treated with onabotulinumtoxinA and placebo, respectively (P<0.001), and 87% of onabotulinumtoxinA-treated participants at year 2 in COMPEL. A clinically meaningful benefit across all 4 domains was met by 20.4% and 8.6% of participants in PREEMPT treated with onabotulinumtoxinA and placebo at 24 weeks, respectively, and 27.2% of onabotulinumtoxinA-treated participants at year 2 in COMPEL.

When evaluating benefits beyond the reduction of headache days, onabotulinumtoxinA-treated participants demonstrated clinically meaningful improvements across multiple domains in the PREEMPT studies and up to 2 years in the COMPEL study.