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<p>The introduction of CGRP-pathway inhibitors has markedly changed the management of migraine, providing effective and well-tolerated options for many patients who were previously difficult to treat. Their overall safety profile appears favorable; however, emerging observations have prompted questions regarding possible infectious complications related to CGRP blockade. This review summarizes the available evidence on infection risk associated with CGRP-targeted therapies, integrating data from randomized clinical trials, post-marketing pharmacovigilance, and experimental immunological studies. While no consistent signal of increased infections has been observed in controlled trials, real-world data and mechanistic considerations suggest that interference with CGRP pathways might, under certain conditions, influence host immune defense. Although infections remain uncommon, awareness of this potential risk is important, particularly in patients with pre-existing immunological frailty or multiple comorbidities. Ongoing surveillance and focused clinical studies will be essential to clarify these aspects and guide safe, long-term use of CGRP inhibitors in everyday clinical practice.</p>

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CGRP-targeted therapies for migraine and the risk of infection

  • 期刊论文

  • 发表日期：

    2026年5月27日

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  • Claudio Tana,
  • Bianca Raffaelli,
  • Roberta Messina,
  • Raffaele Ornello,
  • William Wells-Gatnik,
  • Paolo Martelletti,
  • Livia Moffa

摘要

The introduction of CGRP-pathway inhibitors has markedly changed the management of migraine, providing effective and well-tolerated options for many patients who were previously difficult to treat. Their overall safety profile appears favorable; however, emerging observations have prompted questions regarding possible infectious complications related to CGRP blockade. This review summarizes the available evidence on infection risk associated with CGRP-targeted therapies, integrating data from randomized clinical trials, post-marketing pharmacovigilance, and experimental immunological studies. While no consistent signal of increased infections has been observed in controlled trials, real-world data and mechanistic considerations suggest that interference with CGRP pathways might, under certain conditions, influence host immune defense. Although infections remain uncommon, awareness of this potential risk is important, particularly in patients with pre-existing immunological frailty or multiple comorbidities. Ongoing surveillance and focused clinical studies will be essential to clarify these aspects and guide safe, long-term use of CGRP inhibitors in everyday clinical practice.