Pulmonary adverse events associated with monoclonal antibodies approved for multiple myeloma: a pharmacovigilance study based on the FDA adverse event reporting system

BACKGROUND: The emergence of monoclonal antibodies has notably enhanced the outcomes for multiple myeloma. However, comprehensive assessment of monoclonal antibody-related pulmonary adverse events remains scarce. RESEARCH DESIGN AND METHODS: This pharmacovigilance study analyzed adverse event data of monoclonal antibodies approved for myeloma from 1 January 2016, to 31 December 2023, using OpenVigil 2.1. Adverse event reports were classified based on the MedDRA v24.0 into five pulmonary SMQs: asthma/bronchospasm, infective pneumonia, interstitial lung disease, pulmonary hypertension, and respiratory failure. Disproportionality analyses were utilized to identify potential risk signals. RESULTS: A total of 8,043,250 reports were extracted. Male patients and those aged ≥ 65 years were predominant. Hospitalization and death were common outcomes. Elranatamab had the highest risk for infective pneumonia, elotuzumab had the highest risk for interstitial lung disease, and isatuximab had the highest risk for respiratory failure. Significant associations were discovered between pulmonary adverse events and all five monoclonal antibodies. Viral pneumonia was most prevalent with daratumumab, fungal pneumonia was predominant with elotuzumab, and bacterial pneumonia was predominant with isatuximab, teclistamab, and elranatamab. CONCLUSIONS: This study summarized significant pulmonary adverse event signals associated with monoclonal antibodies approved for myeloma, emphasizing the significance of monitoring interstitial lung disease, respiratory failure, and infective pneumonia.