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 |
ASJC Scopus subject areas
- Clinical Neurology
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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, 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 › peer-review
}
TY - JOUR
T1 - OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine
AU - Lipton, R. 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.
N1 - Funding Information: Study funding: PREEMPT was sponsored by Allergan, Inc., Irvine, CA. Funding Information: Dr. Lipton serves on scientific advisory boards for Allergan, Inc., Merck Serono, Neuralieve, Inc., and Pfizer Inc.; has received funding for travel from the American Headache Society, Cognimed, Diamond Headache Clinic Research, Market Force Communications, Merck Serono, Migraine Research Foundation, Scienta, and Talley Management; serves as Associate Editor of Cephalalgia and on the editorial boards of Neurology® and Headache; receives royalties from publishing Headache in Clinical Practice (Isis Medical Media, 2002), Headache in Primary Care (Isis Medical Media, 1999), Wolff's Headache (Oxford University Press, 2001, 2008), Managing Migraine: A Physician's Guide (BC Decker, 2008), and Managing Migraine: A Patient's Guide (BC Decker, 2008); has received speaker honoraria from the National Headache Foundation, the University of Oklahoma, the American Academy of Neurology, the Annenberg Foundation, Merck Serono, GlaxoSmithKline, and Coherex Medical; serves as a consultant for Allergan, Inc., Autonomic Technologies, MAP Pharmaceuticals, Inc., Neuralieve, Inc., and Novartis; receives/has received research support from AstraZeneca, Ortho-McNeil/Janssen, GlaxoSmithKline, Merck Serono, ProEthic Pharmaceutical, Inc., Advanced Bionics, the NIH/NIA, St. Jude Medical, the Migraine Research Foundation, and the National Headache Foundation; and holds stock options in Minster Pharmaceuticals plc. Dr. Varon is an employee of and holds stock in Allergan, Inc. Dr. Grosberg serves on a scientific advisory board for Kowa Pharmaceuticals America, Inc.; has received speaker honoraria from Merck Serono and GlaxoSmithKline; and receives research support from Allergan, Inc., Merck Serono, CAPNIA, Advanced Bionics, GlaxoSmithKline, Endo Pharmaceuticals, Boston Scientific, Minster Pharmaceuticals plc, and Neuralieve Inc. Dr. McAllister serves as a consultant for Allergan, Inc., GlaxoSmithKline, and Merck Serono; serves on speakers' bureaus for Allergan, Inc., Ipsen, Merz Pharmaceuticals, LLC, GlaxoSmithKline, and Merck Serono; and receives research support from Allergan, Inc., GlaxoSmithKline, Merz Pharmaceuticals, LLC, and Merck Serono. Dr. Freitag serves on scientific advisory boards for Zogenix, Inc., Allergan, Inc., and Nautilus; has received funding for travel and speaker honoraria from GlaxoSmithKline, Zogenix, Inc., Merck Serono, and Nautilus; serves on speakers' bureaus for GlaxoSmithKline, Zogenix, Inc., and Merck Serono; treats patients with chronic migraine headache and administers onabotulinumtoxinA in less than 1% of patients; and has received research support from Advanced Bionics, AstraZeneca, GlaxoSmithKline, Merck and Co., Ortho-McNeil/Janssen, Neurologics; and has served as consultant for Allergan, AstraZeneca, Capnia, Endo, Merck and Co., NuPathe, Ortho-McNeil/Janssen, Valeant Pharmaceuticals, Zogenix, Inc., and GlaxoSmithKline. Dr. Aurora serves on the editorial board of Headache; is listed as author on a patent re: Gastric stasis and improvement with onabotulinumtoxinA (Allergan, Inc.); has received research support from Advanced Bionics, Alexza Pharmaceuticals, AstraZeneca, Allergan, Inc., Boston Scientific, CAPNIA, GlaxoSmithKline, MAP Pharmaceuticals, Inc., Merck and Co, Ortho-McNeil/Janssen, Neuralieve Inc., NuPath Inc., Takeda Pharmaceutical Company Limited, Winston Pharmaceuticals, Inc., and the NIH; has served as a consultant for Astra Zeneca, Valeant Pharmaceuticals International, NMT Medical, Inc., Ortho-McNeil/Janssen, Pfizer Inc, Medtronic, Inc., Merck and Co., GlaxoSmithKline, Allergan, Inc., Neuralieve Inc., NuPath Inc.; and has received honoraria from Merck and Co., GlaxoSmithKline, Nautilius, NuPath Inc., and Zogenix, Inc. Dr. Dodick serves on scientific advisory boards and as a consultant for Allergan, Inc., Pfizer Inc., Novartis, Merck Serono, NuPath Inc., Nautilus, Coherex Medical, Boston Scientific, Medtronic, Inc., GlaxoSmithKline, CoLucid Pharmaceuticals, Autonomic Technologies, Eli Lilly and Company, Miller Medical, Neuralieve Inc., NeurAxon, Inc., St. Jude Medical, Inc., Zogenix, Inc., CogniMed Inc., MAP Pharmaceuticals, Inc., Lundbeck Inc., IMPAX Laboratories, Inc., and the NIH/NINDS; has received funding for travel or speaker honoraria from CogniMed Inc., Miller Medical, and Annenberg Center for Health Sciences; serves as Editor-in-Chief of Cephalalgia, Editor-in-Chief and on the editorial boards of The Neurologist, Lancet Neurology, and Postgraduate Medicine; and has served as Editor-in-Chief of Headache Currents and as an Associate Editor of Headache; receives publishing royalties for Wolff's Headache, 8th edition (Oxford University Press, 2009) and Handbook of Headache (Cambridge University Press, 2010); and receives research support from Boston Scientific, Medtronic, Inc., Advanced Neurostimulation Systems, St. Jude Medical, Inc., and the NIH/NINDS. Dr. Silberstein serves on scientific advisory boards for AGA Medical Corporation, Allergan, Inc., Amgen, Boston Scientific, CAPNIA, Coherex Medical, CoLucid Pharmaceuticals, CyDex Pharmaceuticals, Inc., GlaxoSmithKline, Eli Lilly and Company, MAP Pharmaceuticals, Inc., Medtronic, Inc., Merck Serono, Minster Pharmaceuticals plc, Neuralieve Inc., the NIH/NINDS, NuPathe Inc., Pfizer Inc, St. Jude Medical, and Valeant Pharmaceuticals International; serves on the editorial boards of Cephalalgia and Current Pain and Headache Reports; serves on the speakers' bureaus for Endo Pharmaceuticals, GlaxoSmithKline, and Merck; serves as a consultant for Amgen, Novartis, Opti-Nose, and Sepracor Inc.; his employer receives research support from AGA, Allergan, Boston Scientific, CAPNIA, Coherex, Endo, GlaxoSmithKline, Lilly, MAP, Medtronic, Merck, the NIH/NINDS, NuPathe, St. Jude Medical, Valeant, and Zogenix, Inc.; and receives research support from the American Headache Society and the International Headache Society. Dr. Diener has received honoraria for participation in clinical trials, contribution to advisory boards and/or oral presentations from Addex Pharma, Allergan, Almirall, AstraZeneca, Bayer Vital, Berlin Chemie, CoLucid, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Lilly, La Roche, 3M Medica, Minster, MSD, Novartis, Johnson & Johnson, Pierre Fabre, Pfizer, Schaper and Brummer, Sanofi-Aventis and Weber & Weber; and has also received financial support for research projects from Allergan, Almirall, AstraZeneca, Bayer, GlaxoSmithKline, Jannsen-Cilag and Pfizer. Headache research at the department of Neurology in Essen, where Dr. Diener is professor, is supported by the German Research Council (DFG), the German Ministry of Education and Research (BMBF) and the European Union. R.E. DeGryse is an employee of and holds stock in Allergan, Inc. Dr. Nolan is an employee of Imprint Publication Science, which was funded by Allergan, Inc. Dr. Turkel has patents pending re: Treatment of migraine and is an employee of and holds stock and stock options in Allergan, Inc. Funding Information: The authors thank Allergan, Inc., for funding Imprint Publication Science, New York, NY, for providing support in revising the manuscript, responding to the reviewer comments, and copyediting of this manuscript.
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 -