Effectiveness of onabotulinumtoxinA (BOTOX (R)) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data

Background: This meta-analysis evaluated the real-world effectiveness of onabotulinumtoxinA (BOTOX (R)), the first preventive treatment FDA-approved specifically for chronic migraine in 2010. Methods: We systematically reviewed onabotulinumtoxinA observational data in chronic migraine published between 1 January 2010 and 31 March 2021. Random-effects models evaluated available data for primary and secondary endpoints defined in onabotulinumtoxinA pivotal trials at approximately 24 weeks and 52 weeks. Results: Of the 44 full-text eligible studies (29 prospective; 13 retrospective; 2 other), seven evaluated change from baseline (mean[confidence interval]) at similar to 24 weeks and -52 weeks, respectively, for onabotulinumtoxinA in: number o f headache days/month: (-10.64 [-1 2.31, -8.97]; -10.32 [ 14.92, -5.73]); number of days of acute headache pain medication intake per month (-7.40 [-13.04, -1.77]; overlapping Cls at 52 weeks); total Headache Impact Test-6 score (-11.70 [-1 3.86, -9.54]); -11.80 [14.70, -8.90]); and Migraine-Specific Quality-of-Life v2.1 score (MSQ; 23.60 [CI: 21.56, 25.64]; 30.90 [CI: 28.29, 33.51]). At similar to 24 weeks onabotulinumtoxinA showed total Migraine Disability Assessment score of 44.74 [28.50, 60.99] and >= 50% reduction in migraine days response rate of 46.57% [29.50%, 63.65%]. A sensitivity analysis at study-end suggested durability of onabotulinumtoxinA effectiveness on MSQ. Conclusion: The meta-analysis reflecting real-world practice broadly corroborated with evidence from pivotal and long-term open-label studies of onabotulinumtoxinA in chronic migraine preventive treatment.

Automated summary

This meta-analysis evaluated the real-world effectiveness of BOTOX (R) in the preventive treatment of chronic migraine. The study found significant improvements in headache days, acute headache pain medication intake, Headache Impact Test-6 score, and Migraine-Specific Quality-of-Life score at 24 and 52 weeks with onabotulinumtoxinA. The analysis also highlighted the durability of onabotulinumtoxinA effectiveness in chronic migraine preventive treatment.