Headache prophylaxis with BoNTA: patient characteristics.

OBJECTIVE: To assess the characteristics of patients receiving botulinum toxin type A (BoNTA; BOTOX((R))) in the treatment of headache (HA) disorders.

METHODS: The following observational epidemiologic data and baseline patient characteristics were prospectively collected from eligible patients treated with BoNTA at 10 US HA specialty centers: demographics; HA diagnoses and characteristics (frequency, severity, and disability); prior and current HA treatments and response; clinical response to BoNTA; Migraine Disability Assessment (MIDAS) questionnaire; and adverse events. Patients maintained a daily HA diary and were evaluated at each follow-up visit.

RESULTS: Of 703 patients enrolled (mean age 43.1 years, 78.5% females, 95.4% white), nearly 66% had a diagnosis of chronic migraine (CM), with or without medication overuse. Approximately 75% had severe disability (MIDAS grade IV), and the mean pain rating was 6.5 (where 0 = no pain, 10 = pain as bad as it can be). More than 90% of patients had >or=1 prophylactic HA treatment failure; median number of failures was 4. Significant association was observed between HA frequency and MIDAS grade (P < .001). Approximately 80% of patients with CM had severe (grade IV) disability. The median number of monthly medication days was higher in the group with MIDAS grade IV (P < .001). HA frequency and severity, failed prophylactic therapies, and greater number of coexisting medical conditions were all negatively associated with measures of health-related quality of life.

CONCLUSIONS: Majority of patients treated with BoNTA in a specialty HA center presented with a CM diagnosis. HA disability was correlated with measures of frequency and treatment utilization.