Tumor lysis syndrome associated with monoclonal antibodies in patients with multiple myeloma: a pharmacovigilance study based on the FAERS database.

Although some tumor lysis syndrome (TLS) cases have been reported with multiple myeloma patients taking monoclonal antibodies (mAbs), the association between TLS and mAbs remains mostly unknown. We aim to investigate the association between TLS and mAbs and describe clinical features. We conducted a disproportionality analysis to investigate the link between mAbs and TLS by excluding known confounders and compared with other anticancer drugs. The association between mAbs and TLS was evaluated using information component (IC). Drug-drug interaction signals were calculated based on the Ω shrinkage measure. Parametric distribution with goodness-of-fit test was used for the reported time-to-onset analysis. From 2016 Q1, to 2022 Q4, a total of 274 TLS with mAbs were reported in the FAERS database. 27.0% of TLS cases with mAbs died and 20.1% occurred life-threatening situation. Daratumumab, elotuzumab, and belantamab mafodotin presented a robust disproportionate signal of TLS after excluding known confounders (IC 025 >0). Daratumumab had the highest disproportionate signal of TLS among all anti-cancer drugs for multiple myeloma. Reported time-to-onset analysis showed the median days for TLS with daratumumab, isatuximab, elotuzumab and belantamab mafodotin were 1.5, 14.5, 5.5, 5.5 days, respectively. . The drug-drug interaction analysis showed the co-administration of drugs known to increase urate, induce hyperkalemia or hypocalcemia elevated the reporting frequency for TLS with mAbs (Ω 025 >0). Our post-marketing pharmacovigilance analysis detected the reporting association of TLS and mAbs in patients with multiple myeloma. Additional studies with robust epidemiological study designs that can validate these findings are warranted.