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

Abstract

Background This meta-analysis evaluated the real-world effectiveness of onabotulinumtoxinA (BOTOX®), 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 ∼24 weeks and ∼52 weeks, respectively, for onabotulinumtoxinA in: number of headache days/month: (–10.64 [–12.31, –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 CIs at 52 weeks); total Headache Impact Test-6 score (–11.70 [–13.86, –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 ∼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.

Quantitative and Qualitative Pain Evaluation in Response to OnabotulinumtoxinA for Chronic Migraine: An Observational Real-Life Study

“…The introduction of OBT-A in the treatment of chronic migraine after the encouraging results of the PREEMPT studies [28][29][30] was the first strategy offering an effective therapy without significant side effects [31]. Real-life studies confirmed these benefits in more than ten-year clinical experiences [32][33][34].…”

A Single-Group Study on the Effect of OnabotulinumtoxinA in Patients with Chronic Migraine Associated with Medication Overuse Headache: Pain Catastrophizing Plays a Role

“…In terms of effect, we showed a reduction by 7.9 days per month at six months (95% CI: 5.6 to 10.3 days) which was maintained at 12 months (mean difference 8.0 days per month, 95% CI: 5.6 to 10.3 days). A recent meta-analysis by Lanteri-Minet and colleagues on patients with CM showed a higher average level of improvement, i.e., 10.6 days (95% CI: 9.2 to 12.3) at six months and 10.3 (95% CI: 5.7 to 14.5) at 12 months [ 44 ], and a likewise higher decreased in HIT-6. It has to be noted that, however, the features of the patients herein enrolled are likely different from those resulting from such a pooled analysis.…”

Migraine: from pathophysiology to treatment

“…New evidence on efficacy and tolerability has also emerged for well-known migraine preventives. A metaanalysis has documented the efficacy in chronic migraine of OnabotulinumtoxinA, which allows for a reduction of over 50% in migraine days after 24 weeks of treatment [191]. Several open-label studies have also shown a benefit of combining onabotulinumtoxinA with mAbs to CGRP for CM [192][193][194].…”