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Background and Objectives <p>Anti-calcitonin gene-related peptide (CGRP) therapies have significantly improved migraine prevention, but the long-term impact of discontinuation remains unclear. This systematic review and meta-analysis aimed to evaluate clinical outcomes following the cessation of anti-CGRP therapy.</p> Methods <p>PubMed, Embase, and Cochrane databases were searched up to September 2024 for randomized or observational studies reporting post-discontinuation effects in patients with episodic or chronic migraine who had been preventively treated with anti-CGRP monoclonal antibodies or gepants. The primary outcome was the mean change in monthly migraine days from baseline to post-discontinuation. Secondary outcomes included acute headache medication use, the mean change in migraine frequency from active therapy&#xa0;to treatment cessation, and ≥ 50% responder rates. Heterogeneity was assessed with prediction intervals (PIs) for binary outcomes and <i>I</i><sup>2</sup> statistics for continuous data. Random-effects models pooled mean differences (MDs) and risk ratios (RRs), with subgroup analyses based on follow-up duration, study design, and individuals with chronic migraine.</p> Results <p>Eight studies (<i>n</i> = 1012) evaluating anti-CGRP monoclonal antibodies interruption were included. No studies on gepant cessation were found. Monthly migraine days decreased significantly post-discontinuation compared with baseline (MD −3.78; 95% CI −4.89, −2.67; <i>I</i><sup>2</sup> = 57%; <i>p</i> &lt; 0.05), with reductions of − 5.70 days at 1 month and − 3.62 days at 3 months. Patients with chronic migraine showed sustained reductions (MD − 6.54; 95% CI − 8.64, − 4.43; <i>I</i><sup>2</sup> = 68%; <i>p</i> &lt; 0.05) in the days per month with migraine between cessation and pre-treatment periods. Monthly acute headache medication days declined from baseline (MD − 1.74; 95% CI − 2.84, − 0.64; <i>I</i><sup>2</sup> = 0%; <i>p</i> &lt; 0.05). Monthly migraine days increased at 3 months after discontinuation compared with just before discontinuation (MD 4.43; 95% CI 2.61, 6.25; <i>I</i><sup>2</sup> = 86%; <i>p</i> &lt; 0.05), with monthly acute headache drug usage rising by 3.22 days. Responder rates of ≥ 50% declined (RR 0.42; 95% CI 0.33, 0.53; PI 0.17, 1.03; <i>p</i> &lt; 0.05).</p> Conclusions <p>Migraine burden worsened after discontinuation of anti-CGRP targeting therapies but remained lower than pretreatment levels. Further research is needed to explore disease-modifying potential and optimal discontinuation strategies.</p> <p><i>PROSPERO registration number</i> CRD42024595771.</p>

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Estimating Changes in Clinical Outcomes after Discontinuation of Anti-CGRP Targeting Therapy for Migraine Prophylaxis: A Systematic Review and Meta-analysis

  • 期刊论文

  • 发表日期：

    2025年9月30日

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  • Luana Miyahira Makita,
  • Thales Pardini Fagundes,
  • Pedro Henrique Reginato,
  • Lucca Passow Carpinelli,
  • Giovanna de Freitas Morais,
  • Renata Trinkel Montanarin,
  • Rafael de Freitas Kleimmann,
  • Rafael Eduardo Streit,
  • Aishwarya Koppanatham,
  • Andressa Christine Sales Rodrigues,
  • Elcio Juliato Piovesan

摘要

Background and Objectives

Anti-calcitonin gene-related peptide (CGRP) therapies have significantly improved migraine prevention, but the long-term impact of discontinuation remains unclear. This systematic review and meta-analysis aimed to evaluate clinical outcomes following the cessation of anti-CGRP therapy.

Methods

PubMed, Embase, and Cochrane databases were searched up to September 2024 for randomized or observational studies reporting post-discontinuation effects in patients with episodic or chronic migraine who had been preventively treated with anti-CGRP monoclonal antibodies or gepants. The primary outcome was the mean change in monthly migraine days from baseline to post-discontinuation. Secondary outcomes included acute headache medication use, the mean change in migraine frequency from active therapy to treatment cessation, and ≥ 50% responder rates. Heterogeneity was assessed with prediction intervals (PIs) for binary outcomes and I2 statistics for continuous data. Random-effects models pooled mean differences (MDs) and risk ratios (RRs), with subgroup analyses based on follow-up duration, study design, and individuals with chronic migraine.

Results

Eight studies (n = 1012) evaluating anti-CGRP monoclonal antibodies interruption were included. No studies on gepant cessation were found. Monthly migraine days decreased significantly post-discontinuation compared with baseline (MD −3.78; 95% CI −4.89, −2.67; I2 = 57%; p < 0.05), with reductions of − 5.70 days at 1 month and − 3.62 days at 3 months. Patients with chronic migraine showed sustained reductions (MD − 6.54; 95% CI − 8.64, − 4.43; I2 = 68%; p < 0.05) in the days per month with migraine between cessation and pre-treatment periods. Monthly acute headache medication days declined from baseline (MD − 1.74; 95% CI − 2.84, − 0.64; I2 = 0%; p < 0.05). Monthly migraine days increased at 3 months after discontinuation compared with just before discontinuation (MD 4.43; 95% CI 2.61, 6.25; I2 = 86%; p < 0.05), with monthly acute headache drug usage rising by 3.22 days. Responder rates of ≥ 50% declined (RR 0.42; 95% CI 0.33, 0.53; PI 0.17, 1.03; p < 0.05).

Conclusions

Migraine burden worsened after discontinuation of anti-CGRP targeting therapies but remained lower than pretreatment levels. Further research is needed to explore disease-modifying potential and optimal discontinuation strategies.

PROSPERO registration number CRD42024595771.