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 language | English (US) |
|---|---|
| Pages (from-to) | 1465-1472 |
| Number of pages | 8 |
| Journal | Neurology |
| Volume | 77 |
| Issue number | 15 |
| DOIs | |
| State | Published - Oct 11 2011 |
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ASJC Scopus subject areas
- Clinical Neurology
- Arts and Humanities (miscellaneous)
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OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. / Lipton, Richard B.; Varon, S. F.; Grosberg, B.; McAllister, P. J.; Freitag, F.; Aurora, S. K.; Dodick, D. W.; 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 journal › Article
}
TY - JOUR
T1 - OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine
AU - Lipton, Richard B.
AU - Varon, S. F.
AU - Grosberg, B.
AU - McAllister, P. J.
AU - Freitag, F.
AU - Aurora, S. K.
AU - Dodick, D. W.
AU - Silberstein, S. D.
AU - Diener, H. C.
AU - DeGryse, R. E.
AU - Nolan, M. E.
AU - Turkel, C. C.
PY - 2011/10/11
Y1 - 2011/10/11
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=82955236200&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=82955236200&partnerID=8YFLogxK
U2 - 10.1212/WNL.0b013e318232ab65
DO - 10.1212/WNL.0b013e318232ab65
M3 - Article
C2 - 21956721
AN - SCOPUS:82955236200
VL - 77
SP - 1465
EP - 1472
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 15
ER -