Australian Study Evaluates Real-World Evidence of Botox to Prevent Migraine

Published on: 

Researchers said the results demonstrate the effectiveness of Botox as well as emphasize the importance of real-world data and approaches for establishing the efficacy of a treatment for migraine.

Chronic migraine (CM) is a neurological disease that involves a greater frequency of headache than other migraines. OnabotulinumtoxinA (sold under the name Botox) is consistently effective for treating patients with chronic migraine (CM) in Australia, according to a study published by The Journal of Headache and Pain.

OnabotulinumtoxinA has been approved by Australia’s reimbursement mechanism for medicines, the Pharmaceutical Benefits Scheme (PBS), for preventive treatment of headaches in patients with CM. Researchers conducted a study to evaluate real-world evidence of onabotulinumtoxinA.

Medical records of adults with inadequately controlled CM who received PBS-subsidized onabotulinumtoxinA for the first time, starting in March 2014, were evaluated. The percentage of patients reaching a response of 50% or greater reduction in headaches from baseline after 2 treatment cycles was the primary measure of the research. Patient demographics, headache severity, and Headache Impact Test (HIT-6) were among the many characteristics considered.


“People with CM experience frequent disabling migraine attacks, preventing them from participating in daily activities and significantly impacting their quality of life,” explained the authors. “CM is associated with a substantial societal and familial burden, with increased direct and indirect costs that can lead to a sizable economic burden for patients and healthcare systems. Management of CM involves multiple factors including lifestyle modifications, trigger management, and effective utilization of acute and preventive medications.”

Of the 211 patients considered in the study, there was an average of 25.2 monthly headache days at baseline. Furthermore, the primary outcome analysis demonstrated that 74% of patients achieved a response with an average of 10.6 headache days after 2 treatment cycles. There were also reductions in HIT-6 scores after 2 treatments as well as decreases in days per month of acute pain medication use.

“Nearly three-quarters of patients had their number of monthly headache days cut at least in half in the first 6 months. The benefits of treatment with onabotulinumtoxinA were sustained up to the patients’ final follow-up visit, with a trend toward further improvement after the first 2 treatment cycles,” concluded the authors. “This retrospective analysis of patients with CM adds to the worldwide body of clinical evidence supporting the utility of onabotulinumtoxinA for CM prevention.”

The results of this study demonstrate the effectiveness of onabotulinumtoxinA as well as emphasize the importance of real-world data and approaches for establishing the efficacy of a treatment.


Stark C, Stark R, Limberg N, et al. Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study [published online July 15, 2019]. The Journal of Headache and Pain.