Long-Term OnabotulinumtoxinA Safe, Effective for Chronic Migraine Prophylaxis

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man getting botox injection
Long-term use of onabotulinumtoxinA for chronic migraine prophylaxis was associated with reduced headache day frequency and improved quality of life.

Long-term use of onabotulinumtoxinA for chronic migraine prophylaxis was associated with reduced headache day frequency and improved quality of life, according to a study published in the Journal of Headache and Pain.

For this open-label multicenter prospective study, a total of 633 patients with chronic migraine (average age at baseline, 45.4 years) received onabotulinumtoxinA approximately every 3 months for a duration of 24 months (mean dose, 155.1 U; mean injection sites, 31.4). Participants were assessed for injection practices, headache frequency, quality-of-life measures, health state, and adverse reactions at baseline and at each administration visit.

Patients were treated at least once, and 58.6% had ≥5 treatment sessions (number of sessions: total, 3499; mean, 5.5; maximum, 13). A total of 22.7% of participants discontinued treatment for reasons that included lack of efficacy, inconvenience, and adverse effects. Most of these patients discontinued before the fourth visit.

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At baseline, participants reported an average of 20.6 headache days per month. This was reduced to an average of 7.4 days at the eighth visit (P <.001). At each administration visit, patients indicated improvements in all domains of the Migraine-Specific Quality-of-Life Questionnaire and in health state scores and total scores on the Euro Quality-of-Life 5-Dimension Questionnaire (P <.001 for all).

A total of 18.3% of participants reported an adverse drug reaction, most of which were mild to moderate, and 1.3% of which were considered serious. The remaining adverse drug reaction included eyelid ptosis, neck pain, and musculoskeletal stiffness.

Study limitations include its observational design.

“[L]ong-term…routine clinical use of onabotulinumtoxinA as a preventive medication for [chronic migraine] is efficacious and safe…. Moreover, and with the exception of dose interval, onabotulinumtoxinA was utilised in routine clinical practice as recommended in the [summary of product characteristics],” noted the study authors.

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Reference

Ahmed F, Gaul C, et al. An open-label prospective study of the real-life use of onabotulinumtoxinA for the treatment of chronic migraine: The REPOSE study [published online March 7, 2019]. J Headache Pain. doi:10.1186/s10194-019-0976-1