207 OnabotA for CM: benefits beyond headache-day reduction

Objective

Evaluate the impact of onabotulinumtoxinA treatment in adults with chronic migraine.

Methods

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

Results

Participants (N=1384) were randomized to onabotulinumtoxinA (n=688) or placebo (n=696) in PREEMPT; 716 participants were enrolled in COMPEL. In PREEMPT, significantly more participants treated with onabotulinumtoxinA than 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 domain was met by 72.1% and 56.6% of PREEMPT participants treated with onabotu- linumtoxinA and placebo, respectively (P<0.001), and 87% of onabotulinumtoxinA-treated participants at year 2 in COMPEL.

Conclusions

OnabotulinumtoxinA-treated participants demonstrated clinically meaningful improvements across multiple domains in the PREEMPT studies and up to 2 years in COMPEL.

Sommer_Kathrine@Allergan.com