OnabotulinumtoxinA not only reduced headache frequency for patients with chronic migraines, but also showed potential for clinically reducing depression and anxiety symptoms, improving sleep quality and reducing fatigue symptoms, according to a study published in the Journal of Neurology, Neurosurgery, and Psychiatry.
The Chronic migraine OnabotulinumtoxinA Prolonged Efficacy open-Label (NCT01516892) study evaluated long-term safety and efficacy of onabotulinumtoxinA on patients with chronic migraines for 108 weeks. This publication further evaluates the impact onabotulinumtoxinA has on symptoms of depression, anxiety, fatigue, and poor sleep quality on patients who were in the study by analyzing patients’ scores on the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, Pittsburgh Sleep Quality Index, and the Fatigue Severity Scale.
Of the 716 patients enrolled in the study,
- 52.1% completed the study protocol,
- 84.8% were women,
- 81.3% were white, and
- the mean age was 43 years old.
Overall, onabotulinumtoxinA was found effective at reducing mean headache days from baseline to week 108 by 10.7 days and was well tolerated with treatment-related adverse events occurring in 18.3% of the patients. At baseline, the mean Patient Health Questionnaire-9 score (11.4) indicated moderate depressive symptoms, the mean Generalized Anxiety Disorder-7 score (14.0) indicated moderate anxiety, the mean Pittsburgh Sleep Quality Index (13.3) indicated poor sleep quality, and the mean Fatigue Severity Scale (38.0) indicated significant fatigue. By week 108, the mean Patient Health Questionnaire-9 score was reduced by 4.5 and the mean Generalized Anxiety Disorder-7 score was reduced by 2.8. The mean Pittsburgh Sleep Quality Index was significantly reduced from a baseline score of 13.3 to 11.0 at week 108 and the mean Fatigue Severity Scale scores were significantly reduced from 38.0 at baseline to 30.1 at week 108 (P <.0001 for all).
By week 24, patients who experienced a ≥50% decrease in headache day frequency had a greater decrease in the Patient Health Questionnaire-9 score (-6.3 vs -3.6), a higher likelihood of improvements in depression symptoms (83.7% vs 60.3%), a greater decrease in Generalized Anxiety Disorder-7 score (-7.6 vs -5.1), and a higher likelihood of improvements in anxiety symptoms (86.0% vs 71.4%) when compared with patients who did not experience a ≥50% decrease in headache day frequency.
Limitations of this study include unintentional bias and low persistency rates due to the nonrandomized and long-term follow-up nature of this study. In addition, depression and anxiety symptoms were based on self-reported questionnaires rather than clinical diagnosis.
The researchers concluded that “onabotulinumtoxinA may have beneficial effects beyond those of headache frequency reduction, particularly in people with [chronic migraine] with psychiatric comorbidities.”
This study was supported by Allergan. Please refer to the original reference for a complete list of authors’ disclosures.
Blumenfeld AM, Tepper SJ, Robbins LD, et al. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety [published online January 10, 2019]. J Neurol Neurosurg Psychiatry doi: 10.1136/jnnp-2018-319290