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Background <p>Calcitonin gene-related peptide (CGRP) is a potential biomarker targeted by evolving therapies against episodic and chronic migraine with/without symptomatic medication overuse. The objective of this study was to assess the effectiveness of anti-CGRP therapies (monoclonal antibodies and gepants) for several migraine headache parameters.</p> Methods <p>The meta-analysis of 22 randomized-controlled, prospective cross-sectional, and observational studies was undertaken via the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach. The primary endpoints for monoclonal antibodies (mAbs) and gepants were ≥ 50% treatment response, ≥ 50% monthly reduction in migraine days from baseline, and ≥ 50% reduction in mean number of moderate or severe migraine days per month. Odds ratios (ORs) and mean differences for the study variables were calculated within 95% confidence intervals (CIs) via dichotomous datatype, Mantel-Haenszel, and random effects methods.</p> Results <p>The clinical data of 19,949 patients with a diagnosis of episodic or chronic migraine with or without medication overuse headache were analyzed. The mean age of the patients was 40 ± 5&#xa0;years, and the mean weight was 72 ± 2&#xa0;kg. The included studies had a higher percentage of female patients compared to males (80% vs 20%), and the mean body mass index was 25 ± 2&#xa0;kg/m<sup>2</sup>. The results indicated the superiority of mAbs compared to the placebo treatments in improving ≥ 50% treatment response (OR = 2.70, 95% CI 1.90, 3.84; <i>p</i> &lt; 0.00001) and ≥ 50% monthly migraine days reduction (OR = 2.13, 95% CI 1.54–2.93, <i>p</i> &lt; 0.00001). The findings underscored the efficacy of gepants in achieving ≥ 50% monthly reduction in moderate to severe migraine days (OR = 1.66, 95% CI 1.26, 2.17; <i>p</i> = 0.0003), two hourly post-treatment pain freedom (OR = 1.67, 95% CI 1.45, 1.93; <i>p</i> &lt; 0.00001), and sustained pain relief (OR = 1.92, 95% CI 1.62, 2.26, <i>p</i> &lt; 0.00001) in comparison to the standard therapy. Neither mAbs nor gepants were superior to the placebo treatments in minimizing the incidence of adverse events.</p> Conclusion <p>This study substantiates the efficacy of mAbs and gepants in chronic/episodic migraine patients with/without medication overuse headaches. Future studies should focus on the safety, tolerability, and long-term efficacy analysis of anti-CGRP therapies in patients with chronic migraine.</p>

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A Systematic Review and Meta-analysis of Anti-calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies (mAbs) and Gepants for Episodic or Chronic Migraine With or Without Medication Overuse Headache

  • 期刊论文

  • 发表日期：

    2025年10月7日

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  • Abouch Valenty Krymchantowski,
  • Ana Gabriela Krymchantowski,
  • Maria Lúcia Veluttini Pimentel,
  • Carla da Cunha Jevoux,
  • Ervin Michelstaedter Cotrik

摘要

Background

Calcitonin gene-related peptide (CGRP) is a potential biomarker targeted by evolving therapies against episodic and chronic migraine with/without symptomatic medication overuse. The objective of this study was to assess the effectiveness of anti-CGRP therapies (monoclonal antibodies and gepants) for several migraine headache parameters.

Methods

The meta-analysis of 22 randomized-controlled, prospective cross-sectional, and observational studies was undertaken via the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach. The primary endpoints for monoclonal antibodies (mAbs) and gepants were ≥ 50% treatment response, ≥ 50% monthly reduction in migraine days from baseline, and ≥ 50% reduction in mean number of moderate or severe migraine days per month. Odds ratios (ORs) and mean differences for the study variables were calculated within 95% confidence intervals (CIs) via dichotomous datatype, Mantel-Haenszel, and random effects methods.

Results

The clinical data of 19,949 patients with a diagnosis of episodic or chronic migraine with or without medication overuse headache were analyzed. The mean age of the patients was 40 ± 5 years, and the mean weight was 72 ± 2 kg. The included studies had a higher percentage of female patients compared to males (80% vs 20%), and the mean body mass index was 25 ± 2 kg/m2. The results indicated the superiority of mAbs compared to the placebo treatments in improving ≥ 50% treatment response (OR = 2.70, 95% CI 1.90, 3.84; p < 0.00001) and ≥ 50% monthly migraine days reduction (OR = 2.13, 95% CI 1.54–2.93, p < 0.00001). The findings underscored the efficacy of gepants in achieving ≥ 50% monthly reduction in moderate to severe migraine days (OR = 1.66, 95% CI 1.26, 2.17; p = 0.0003), two hourly post-treatment pain freedom (OR = 1.67, 95% CI 1.45, 1.93; p < 0.00001), and sustained pain relief (OR = 1.92, 95% CI 1.62, 2.26, p < 0.00001) in comparison to the standard therapy. Neither mAbs nor gepants were superior to the placebo treatments in minimizing the incidence of adverse events.

Conclusion

This study substantiates the efficacy of mAbs and gepants in chronic/episodic migraine patients with/without medication overuse headaches. Future studies should focus on the safety, tolerability, and long-term efficacy analysis of anti-CGRP therapies in patients with chronic migraine.