Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety

Andrew M Blumenfeld; Stewart J Tepper; Lawrence D Robbins; Aubrey Manack Adams; Dawn C Buse; Amelia Orejudos; Stephen D Silberstein

doi:10.1136/jnnp-2018-319290

Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety

J Neurol Neurosurg Psychiatry. 2019 Mar;90(3):353-360. doi: 10.1136/jnnp-2018-319290. Epub 2019 Jan 10.

Authors

Andrew M Blumenfeld¹, Stewart J Tepper², Lawrence D Robbins³, Aubrey Manack Adams⁴, Dawn C Buse⁵, Amelia Orejudos⁴, Stephen D Silberstein⁶

Affiliations

¹ Headache Center of Southern California, The Neurology Center, Carlsbad, California, USA blumenfeld@neurocenter.com.
² Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
³ Robbins Headache Clinic, Riverwoods, Illinois, USA.
⁴ Allergan, Irvine, California, USA.
⁵ Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.
⁶ Department of Neurology, Jefferson Headache Center, Philadelphia, Pennsylvania, USA.

Abstract

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.

Keywords: anxiety; comorbidities; depression; fatigue; onabotulinumtoxinA; sleep.

Publication types

Clinical Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Anxiety Disorders / diagnosis
Anxiety Disorders / drug therapy*
Anxiety Disorders / etiology
Botulinum Toxins, Type A / therapeutic use*
Chronic Disease
Depressive Disorder / diagnosis
Depressive Disorder / drug therapy*
Depressive Disorder / etiology
Drug Administration Schedule
Fatigue / diagnosis
Fatigue / drug therapy
Fatigue / etiology
Female
Humans
Male
Migraine Disorders / drug therapy*
Migraine Disorders / psychology*
Neuromuscular Agents / therapeutic use*
Prospective Studies
Sleep Wake Disorders / diagnosis
Sleep Wake Disorders / drug therapy
Sleep Wake Disorders / etiology
Treatment Outcome

Substances

Neuromuscular Agents
Botulinum Toxins, Type A

Associated data

ClinicalTrials.gov/NCT01516892