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Introduction <p>Monoclonal antibodies (mAbs) have revolutionized the treatment of multiple myeloma (MM), demonstrating remarkable effectiveness, despite potential adverse events (AEs). This study aims to identify unexpected signals of disproportionate reporting (SDRs) for cardiovascular (CV) and respiratory AEs associated with mAbs in MM treatment.</p> Methods <p>From January 2015 to December 2023, reports involving suspected drugs (daratumumab, elotuzumab, elranatamab, isatuximab, belantamab mafodotin, teclistamab, and talquetamab) were analyzed in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Descriptive analysis was followed by disproportionality analyses first comparing mAbs to all other drugs (reference group, RG1), and subsequently conducting a sensitivity analysis against other MM drugs (RG2).</p> Results <p>Out of 13,496,241 reports, 31,052 (0.2%) were associated with MM, with 6574 (0.1%) linked to CV and respiratory adverse events, primarily involving older population (<i>n</i> = 3441; 52.3%) and male (<i>n</i> = 3338; 50.8%) patients. Disproportionality analyses identified unexpected SDRs for daratumumab, including cardiac failure (<i>n</i> = 322; RG1: ROR = 4.74, CI 95% = 4.24–5.29; RG2: ROR = 4.42, 95% CI = 3.91–4.99), embolic and thrombotic event, such as pulmonary embolism (162; RG1: 2.44, 2.09–2.85), deep vein thrombosis (126; RG1: 2.95, 2.47–3.52), and respiratory failure (192; RG1: 4.06, 3.52–4.68; RG2: 4.2, 3.59–4.91). Isatuximab was linked to cardiac arrhythmia, such as atrial fibrillation (46; RG1: 2.54, 1.9–3.4; RG2: 1.35, 1.01–1.81), embolic and thrombotic event, including deep vein thrombosis (26; RG1: 2.93, 1.99–4.3) and pulmonary embolism (89; RG1: 6.56, 5.32–8.1; RG2: 2.93, 2.37–3.63). Elotuzumab showed also SDRs for atrial fibrillation (56; RG1: 3.68, 2.82–4.79; RG2: 1.96, 1.5–2.56) and deep vein thrombosis (41; RG1: 5.49, 4.03–7.47).</p> Conclusion <p>Unexpected CV and respiratory AEs with clinical relevance not previously reported in literature have been identified underlining the importance of pharmacovigilance.</p>

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Unveiling cardiovascular and respiratory toxicities with monoclonal antibodies in multiple myeloma: disproportionality analysis from the FDA Adverse Event Reporting System

  • 期刊论文

  • 发表日期：

    2025年3月17日

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  • Maria Antonietta Barbieri,
  • Giulia Russo,
  • Giuseppe Cicala,
  • Giuseppe Andò,
  • Tindara Franchina,
  • Nicola Silvestris,
  • Mariacarmela Santarpia,
  • Edoardo Spina

摘要

Introduction

Monoclonal antibodies (mAbs) have revolutionized the treatment of multiple myeloma (MM), demonstrating remarkable effectiveness, despite potential adverse events (AEs). This study aims to identify unexpected signals of disproportionate reporting (SDRs) for cardiovascular (CV) and respiratory AEs associated with mAbs in MM treatment.

Methods

From January 2015 to December 2023, reports involving suspected drugs (daratumumab, elotuzumab, elranatamab, isatuximab, belantamab mafodotin, teclistamab, and talquetamab) were analyzed in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Descriptive analysis was followed by disproportionality analyses first comparing mAbs to all other drugs (reference group, RG1), and subsequently conducting a sensitivity analysis against other MM drugs (RG2).

Results

Out of 13,496,241 reports, 31,052 (0.2%) were associated with MM, with 6574 (0.1%) linked to CV and respiratory adverse events, primarily involving older population (n = 3441; 52.3%) and male (n = 3338; 50.8%) patients. Disproportionality analyses identified unexpected SDRs for daratumumab, including cardiac failure (n = 322; RG1: ROR = 4.74, CI 95% = 4.24–5.29; RG2: ROR = 4.42, 95% CI = 3.91–4.99), embolic and thrombotic event, such as pulmonary embolism (162; RG1: 2.44, 2.09–2.85), deep vein thrombosis (126; RG1: 2.95, 2.47–3.52), and respiratory failure (192; RG1: 4.06, 3.52–4.68; RG2: 4.2, 3.59–4.91). Isatuximab was linked to cardiac arrhythmia, such as atrial fibrillation (46; RG1: 2.54, 1.9–3.4; RG2: 1.35, 1.01–1.81), embolic and thrombotic event, including deep vein thrombosis (26; RG1: 2.93, 1.99–4.3) and pulmonary embolism (89; RG1: 6.56, 5.32–8.1; RG2: 2.93, 2.37–3.63). Elotuzumab showed also SDRs for atrial fibrillation (56; RG1: 3.68, 2.82–4.79; RG2: 1.96, 1.5–2.56) and deep vein thrombosis (41; RG1: 5.49, 4.03–7.47).

Conclusion

Unexpected CV and respiratory AEs with clinical relevance not previously reported in literature have been identified underlining the importance of pharmacovigilance.