Objective To assess the effects of onabotulinumtoxinA treatment for chronic migraine (CM) on comorbid symptoms of depression, anxiety, fatigue and poor sleep quality.
Methods The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) study is a multicentre, open-label, prospective study assessing the long-term safety and efficacy of onabotulinumtoxinA 155 U over nine treatments (108 weeks) in adults with CM. The Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder (GAD-7) scales were used to assess the effects of onabotulinumtoxinA on comorbid symptoms of depression and anxiety, respectively. A clinically meaningful improvement was assessed by the percentage of patients experiencing a ≥1 severity category reduction in PHQ-9 and GAD-7. The effects of onabotulinumtoxinA on associated sleep quality and fatigue were assessed using the Pittsburgh Sleep Quality Index and Fatigue Severity Scale, respectively.
Results OnabotulinumtoxinA treatment was associated with sustained reduction in headache days and PHQ-9 and GAD-7 scores in the analysis population (n=715) over 108 weeks. PHQ-9 and GAD-7 scores were significantly reduced at all time points in patients with clinically significant symptoms of depression and/or anxiety at baseline. By week 108, 78.0% and 81.5% had clinically meaningful improvement in depression and anxiety symptoms, respectively. Sleep quality and symptoms of fatigue also improved; however, less is understood about clinically meaningful changes in these measures. No new safety concerns were identified.
Conclusion In addition to reducing headache frequency, onabotulinumtoxinA treatment for CM was associated with clinically meaningful reduction in symptoms of depression and anxiety, and improved associated symptoms of poor sleep quality and fatigue.
Trial registration number NCT01516892.
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Contributors AMB, SJT, LDR, AMA, DCB and SDS conceived and developed these post hoc analyses of the COMPEL study data. AO conducted the statistical analyses. All authors discussed the results and contributed to the final manuscript and approved it for submission.
Funding The study was sponsored by Allergan (Dublin, Ireland). Allergan funded the editorial and writing support, and provided support for the study design, and the collection, analysis and interpretation of the data. Other than in their role as authors, employees of Allergan did not have a role in the final decision of which data to include in the manuscript and on the decision to submit the manuscript for publication.
Competing interests AMB has served on advisory boards for Allergan, Amgen, Alder, Teva, Supernus, Promius, Eaglet and Lilly, and has received funding for speaking from Allergan, Amgen, Pernix, Supernus, Depomed, Avanir and Promius. He holds patents for onabotulinumtoxinA in migraine assigned to Allergan. SJT is an employee of the Dartmouth-Hitchcock Medical Center and receives a salary from the American Headache Society (AHS). He also serves as a consultant for Acorda, Alder, Alexsa, Allergan, Amgen, ATI, BioVision, Cefaly, Charleston Laboratories, DeepBench, Dr Reddy’s, ElectroCore, Eli Lilly, eNeura, GLG, Guidepoint Global, Impax, Neurolief, Novartis, Scion Neurostim, Slingshot Insights, Supernus, Teva and Zosano, and has received royalties for books published by Springer. His employer receives research grants from Alder, Allergan, Amgen, ATI, Dr Reddy's, Scion Neurostim, Teva and Zosano. LDR has served as a speaker for Avanir, Pernix and Merck. AMA and AO are employees of Allergan, and AMA holds stock in the company. DCB has received grant support and honoraria from Allergan, Avanir, Amgen, Eli Lilly and Company, and Promius, and for work on the editorial board of Current Pain and Headache Reports. SDS has served as a consultant and/or advisory panel member and received honoraria from Alder BioPharmaceuticals, Allergan, Amgen, Avanir Pharmaceuticals, eNeura, ElectroCore Medical, Eli Lilly and Company, Medscape and Teva Pharmaceuticals, and grants from Amgen and Teva Pharmaceuticals. His employer has received research support from Allergan, Amgen, Cumberland Pharmaceuticals, ElectroCore Medical, Eli Lilly and Company, and Troy Healthcare.
Patient consent for publication Not required.
Ethics approval The central IRB for the COMPEL study was Quorum Review IRB in Seattle, Washington.
Provenance and peer review Not commissioned; externally peer reviewed.
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