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Background <p>Advanced therapies have substantially improved the management of Crohn’s disease (CD), offering better outcomes than conventional treatments. However, concerns remain regarding their long-term cardiovascular safety, as trial data are limited by selective populations and follow-up.</p> Aims <p>This study aimed to characterize FAERS reports of cardiovascular adverse events (cAEs) associated with seven advanced therapies for CD, including adalimumab, infliximab, vedolizumab, certolizumab pegol, ustekinumab, risankizumab, and upadacitinib, by evaluating reporting characteristics, fatal outcome proportions, disproportionality signals, report-level associated factors, and time-to-onset patterns.</p> Methods <p>FAERS reports (2004–2024) were analyzed. cAEs were identified via MedDRA queries, with descriptive statistics and disproportionality analyses (reporting odds ratios), and chi-square/Fisher’s tests for significance.</p> Results <p>Among 56,725 FAERS reports involving the seven advanced therapies, 10,549 reports included at least one cAE. At the Preferred Term (PT) level, cAEs represented 1.35% of all reported adverse events in CD, with the highest proportion observed for infliximab (2.26%) and the lowest for certolizumab pegol (0.77%). Fatal outcomes accounted for 5.95% of cAE reports. Adalimumab, infliximab, and ustekinumab-associated cAEs showed earlier reporting patterns within the first 100 days after treatment initiation, whereas vedolizumab demonstrated a broader time-to-onset distribution.</p> Conclusions <p>Although cAEs represented a relatively small proportion of reported adverse events associated with advanced therapies for CD, fatal outcomes were observed among these reports. Differences in PT-level cAE proportions and time-to-onset patterns were observed across therapies, suggesting the need for continued cardiovascular safety monitoring during advanced therapy use in CD and further validation in real-world clinical cohorts.</p>

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Cardiovascular adverse events associated with advanced therapies for Crohn’s disease: a FAERS database study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月29日

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  • Chuoyi Liang,
  • Wenli Jiao,
  • Jingyi Gu,
  • Jiayi Lin,
  • Sijia Wei,
  • Sihua Liang,
  • Xi Jing,
  • Fengxia Yan

摘要

Background

Advanced therapies have substantially improved the management of Crohn’s disease (CD), offering better outcomes than conventional treatments. However, concerns remain regarding their long-term cardiovascular safety, as trial data are limited by selective populations and follow-up.

Aims

This study aimed to characterize FAERS reports of cardiovascular adverse events (cAEs) associated with seven advanced therapies for CD, including adalimumab, infliximab, vedolizumab, certolizumab pegol, ustekinumab, risankizumab, and upadacitinib, by evaluating reporting characteristics, fatal outcome proportions, disproportionality signals, report-level associated factors, and time-to-onset patterns.

Methods

FAERS reports (2004–2024) were analyzed. cAEs were identified via MedDRA queries, with descriptive statistics and disproportionality analyses (reporting odds ratios), and chi-square/Fisher’s tests for significance.

Results

Among 56,725 FAERS reports involving the seven advanced therapies, 10,549 reports included at least one cAE. At the Preferred Term (PT) level, cAEs represented 1.35% of all reported adverse events in CD, with the highest proportion observed for infliximab (2.26%) and the lowest for certolizumab pegol (0.77%). Fatal outcomes accounted for 5.95% of cAE reports. Adalimumab, infliximab, and ustekinumab-associated cAEs showed earlier reporting patterns within the first 100 days after treatment initiation, whereas vedolizumab demonstrated a broader time-to-onset distribution.

Conclusions

Although cAEs represented a relatively small proportion of reported adverse events associated with advanced therapies for CD, fatal outcomes were observed among these reports. Differences in PT-level cAE proportions and time-to-onset patterns were observed across therapies, suggesting the need for continued cardiovascular safety monitoring during advanced therapy use in CD and further validation in real-world clinical cohorts.