OnabotulinumtoxinA for Treatment of Chronic Migraine: PREEMPT 24-Week Pooled Subgroup Analysis of Patients Without Medication Overuse
Background: Chronic migraine (CM) is a prevalent, disabling primary headache disorder. Most patients in CM clinical trials overuse acute headache medications (AHM). The efficacy of prophylactic medications in CM patients without overuse of AHM is unclear. This analysis evaluated efficacy and tolerability of onabotulinumtoxinA in a CM subgroup without AHM overuse (MedO-No).
Methods: PREEMPT (two phase 3 studies: 24-week, double-blind, placebo-controlled, parallel-group phase, followed by 32-week, open-label phase) evaluated onabotulinumtoxinA for prophylaxis of headaches in CM (≥15 days/month with headache lasting 4 hours/day or longer). Patients were stratified based on AHM use during 28-day baseline and randomized (1:1) to onabotulinumtoxinA (155-195U) or placebo every 12 weeks. Multiple headache-symptom measures were evaluated at Week 24, including mean change from baseline in headache-day frequency (primary). Pooled results from MedO-No subgroup are reported.
Results: 480 (n=243 onabotulinumtoxinA; n=237 placebo) of 1384 patients met MedO-No criteria. At Week 24, onabotulinumtoxinA treatment significantly reduced headache-day frequency compared to placebo (-8.8/onabotulinumtoxinA;-7.3/placebo: p=0.013). Significant improvements from baseline (p≤0.027) also favored onabotulinumtoxinA at Week 24 for frequency of migraine-days, moderate/severe headache-days, total cumulative hours of headache on headache-days, and percent of patients with severe (≥60) headache impact test (HIT-6) scores. Improvements in total HIT-6 and migraine-specific questionnaire scores all significantly favored onabotulinumtoxinA over placebo at Week 24 (p≤0.032). Few patients in this subgroup discontinued because of an adverse event (AE); AEs were consistent with overall PREEMPT tolerability.
Conclusion: OnabotulinumtoxinA is effective and well-tolerated for prophylaxis of headache in CM patients who do not overuse AHM.
Support: Allergan, Inc.
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