Abstract

Purpose: Calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are new agents approved by the US Food and Drug Administration for preventive treatment of chronic migraine. Comparison between CGRPmAbs and previously approved Botulinum neurotoxin A (BoNT-A) will inform optimal preventive treatment of chronic migraine, but head-to-head trials are lacking. We therefore aimed to perform adjusted indirect comparison between CGRPmAbs and BoNT-A through a meta-analysis. Methods: OVID MEDLINE, EMBASE and the Cochrane central register of controlled trials, clinical registries, and government websites were searched from inception to September 2019. Randomized controlled trials comparing CGRPmAbs or BoNT-A with placebo in the preventive treatment of chronic migraine were included. The primary outcomes were headache days and migraine days measured at week 12. Data were synthesized by using a frequentist approach; and the treatments were ranked by P-score. Results: We included 10 trials (n = 4,678) after screening 1049 candidates. Six trials were with low risk of bias. Fremanezumab had an effect similar to BoNT-A in the reduction of headache days at week 12 (standard mean difference [SMD] 0.08, 95%CI -0.55 to -0.7). Galcanezumab reduced more migraine days than BoNT-A at week 12 (SMD, -0.94, 95%CI −1.24 to −0.63); fremanezumab showed similar findings (SMD, −0.55, 95%CI −0.85 to −0.24). Galcanezumab and fremanezumab had better effect in mitigating headache impact at week 12. CGRPmAbs and BoNT-A had similar adverse event rate. Conclusion: CGRPmAbs and BoNT-A had similar effect in the preventive treatment of chronic migraine. BoNT-A might be preferentially selected owing to its cost-effectiveness profiles. Further studies with direct comparison of the two treatments are warranted.

Highlights

  • Patients with chronic migraine have monthly headaches ≥15 days and monthly migraine attacks ≥8 days for at least 3 months (Headache Classification Committee of the International Headache Society (IHS), 2013)

  • Galcanezumab reduced more migraine days than Botulinum neurotoxin A (BoNT-A) at week 12 (SMD, -0.94, 95% 95% confidence interval. Fremanezumab 675/225/225mg (CI) −1.24 to −0.63); fremanezumab showed similar findings (SMD, −0.55, 95%confidence intervals (95%CIs) −0.85 to −0.24)

  • We included 4 randomized controlled trials (RCTs) (n 1981) in week-12 assessment, and the results showed that fremanezumab 675/225/225 mg ranked the most effective

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Summary

Introduction

Patients with chronic migraine have monthly headaches ≥15 days and monthly migraine attacks ≥8 days for at least 3 months (Headache Classification Committee of the International Headache Society (IHS), 2013). Chronic migraine has larger impact on socioeconomic aspect and quality of life (Buse et al, 2012). The treatment of chronic migraine includes two steps. The first is to stop or reduce the intake of acute analgesics to prevent medication overuse, and the second step is to use preventive treatment. Several pharmacological and non-pharmacological treatments are suggested for the preventive treatment of chronic migraine, but very few of them are evidence based. Topiramate is the only orally administered drug with high-quality evidence to support its efficacy and safety in treating chronic migraine, . The high rate of adverse events and the potential risk of causing depression restrict its use for chronic migraine. There is a lack of high-quality evidence for non-pharmacological treatments

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