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Abstract
Objective: To assess the effects of treatment with onabotulinumtoxinA (Botox, Allergan, Inc., Irvine, CA) on health-related quality of life (HRQoL) and headache impact in adults with chronic migraine (CM).
Methods: The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program (PREEMPT 1 and 2) included a 24-week, double-blind phase (2 12-week cycles) followed by a 32-week, open-label phase (3 cycles). Thirty-one injections of 5U each (155 U of onabotulinumtoxinA or placebo) were administered to fixed sites. An additional 40 U could be administered “following the pain.” Prespecified analysis of headache impact (Headache Impact Test [HIT]–6) and HRQoL (Migraine-Specific Quality of Life Questionnaire v2.1 [MSQ]) assessments were performed. Because the studies were similar in design and did not notably differ in outcome, pooled results are presented here.
Results: A total of 1,384 subjects were included in the pooled analyses (onabotulinumtoxinA, n = 688; placebo, n = 696). Baseline mean total HIT-6 and MSQ v2.1 scores were comparable between groups; 93.1% were severely impacted based on HIT-6 scores ≥60. At 24 weeks, in comparison with placebo, onabotulinumtoxinA treatment significantly reduced HIT-6 scores and the proportion of patients with HIT-6 scores in the severe range at all timepoints including week 24 (p < 0.001). OnabotulinumtoxinA treatment significantly improved all domains of the MSQ v2.1 at 24 weeks (p < 0.001).
Conclusions: Treatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL.
Classification of evidence: This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.
GLOSSARY
- CM =
- chronic migraine;
- DB =
- double-blind phase;
- EF =
- emotional functioning;
- EM =
- episodic migraine;
- HIT =
- Headache Impact Test;
- HRQoL =
- health-related quality of life;
- ICHD-2 =
- International Classification of Headache Disorders, 2nd edition;
- MID =
- minimal important difference;
- MSQ =
- Migraine-Specific Quality of Life Questionnaire v2.1;
- PREEMPT =
- Phase III Research Evaluating Migraine Prophylaxis Therapy;
- RP =
- role preventive;
- RR =
- role restrictive
Footnotes
Study funding: PREEMPT was sponsored by Allergan, Inc., Irvine, CA.
- Received November 18, 2010.
- Accepted July 6, 2011.
- Copyright © 2011 by AAN Enterprises, Inc.
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