VALENCIA, SPAIN – OnabotulinumtoxinA injections given for treatment of chronic migraine provide a major side benefit: clinically meaningful improvement in comorbid moderate to severe depression, Dr. Stewart J. Tepper reported at the International Headache Congress.
He presented an uncontrolled, retrospective study with prospectively collected patient-reported outcomes data in 429 chronic migraine patients who underwent two or more sessions of onabotulinumtoxinA (Botox) injections, a treatment approved by the Food and Drug Administration for chronic migraine since 2010.
Since the safety and efficacy of the treatment for chronic migraine are already well established, the goal of this study was to examine change in depression, a common comorbid condition in this population. The primary outcome measure was change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to follow-up at 6-12 months.
In the overall study population, PHQ-9 scores improved significantly, from a mean of 14.4 at baseline to 11.3 post Botox. But the results became considerably more intriguing when broken by baseline level of depression, according to Dr. Tepper, professor of medicine (neurology) at Case Western Reserve University, Cleveland, and director of research at the Neurological Center for Pain at the Cleveland Clinic.
Seventy percent of the chronic migraine patients had at least mild depression as reflected in a baseline PHQ-9 score of 5 or more. Among the 145 patients with mild depression as evidenced by a PHQ-9 of 5-9, Botox therapy wasn’t associated with any impact on depression scores: a mean of 6.8 at baseline and 6.8 at follow-up.
In contrast, among the 75 patients with moderate depression as defined by a PHQ-9 score of 10-14, depression scores improved significantly from 11.8 to 9.6. Moreover, in the 30 patients with baseline moderate/severe depression as evidenced by a PHQ-9 of 15-19, scores improved from 17 at pretreatment to 13.4 at follow-up. The largest absolute improvement in depression scores was seen in those who were most severely depressed: in the 16 patients with baseline severe depression as defined by a PHQ-9 score of 20-27, mean scores improved from 21.8 at baseline to 15.2, Dr. Tepper reported at the meeting sponsored by the International Headache Society and the American Headache Society.
Other patient-reported outcomes also improved significantly following two or more onabotulinumtoxinA treatment sessions.
Dr. Tepper reported no financial conflicts regarding this study, which was conducted exclusively with institutional funds.