OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine

R. B. Lipton, S. F. Varon, B. Grosberg, P. J. McAllister, F. Freitag, S. K. Aurora, David William Dodick, S. D. Silberstein, H. C. Diener, R. E. DeGryse, M. E. Nolan, C. C. Turkel

Research output: Contribution to journalArticle

86 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1465-1472
Number of pages8
JournalNeurology
Volume77
Issue number15
DOIs
StatePublished - Oct 11 2011

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Migraine Disorders
Headache
Quality of Life
Placebos
Therapeutics
onabotulinumtoxinA
Research
Pain
Injections
Health

ASJC Scopus subject areas

  • Clinical Neurology
  • Arts and Humanities (miscellaneous)

Cite this

Lipton, R. B., Varon, S. F., Grosberg, B., McAllister, P. J., Freitag, F., Aurora, S. K., ... Turkel, C. C. (2011). OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. Neurology, 77(15), 1465-1472. https://doi.org/10.1212/WNL.0b013e318232ab65

OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. / Lipton, R. B.; Varon, S. F.; Grosberg, B.; McAllister, P. J.; Freitag, F.; Aurora, S. K.; Dodick, David William; Silberstein, S. D.; Diener, H. C.; DeGryse, R. E.; Nolan, M. E.; Turkel, C. C.

In: Neurology, Vol. 77, No. 15, 11.10.2011, p. 1465-1472.

Research output: Contribution to journalArticle

Lipton, RB, Varon, SF, Grosberg, B, McAllister, PJ, Freitag, F, Aurora, SK, Dodick, DW, Silberstein, SD, Diener, HC, DeGryse, RE, Nolan, ME & Turkel, CC 2011, 'OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine', Neurology, vol. 77, no. 15, pp. 1465-1472. https://doi.org/10.1212/WNL.0b013e318232ab65
Lipton RB, Varon SF, Grosberg B, McAllister PJ, Freitag F, Aurora SK et al. OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. Neurology. 2011 Oct 11;77(15):1465-1472. https://doi.org/10.1212/WNL.0b013e318232ab65
Lipton, R. B. ; Varon, S. F. ; Grosberg, B. ; McAllister, P. J. ; Freitag, F. ; Aurora, S. K. ; Dodick, David William ; Silberstein, S. D. ; Diener, H. C. ; DeGryse, R. E. ; Nolan, M. E. ; Turkel, C. C. / OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. In: Neurology. 2011 ; Vol. 77, No. 15. pp. 1465-1472.
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AU - Varon, S. F.

AU - Grosberg, B.

AU - McAllister, P. J.

AU - Freitag, F.

AU - Aurora, S. K.

AU - Dodick, David William

AU - Silberstein, S. D.

AU - Diener, H. C.

AU - DeGryse, R. E.

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N2 - 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.

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