Mining adverse events of interstitial lung disease associated with antibody-drug conjugate based upon FAERS database
OBJECTIVE To conduct data mining on the adverse events of interstitial lung disease associated with antibody-drug conjugate(ADC)to provide rationales for safe clinical use of ADC based upon the U.S.FDA Adverse Event Reporting Sys-tem(FAERS).METHODS From the first quarter of 2004(Q1)to the fourth quarter of 2022(Q4),the FAERS data were extracted for disproportionality analysis.The methods of reporting odds ratio(ROR)and information component(IC)were uti-lized for evaluating the relationship between ADC and interstitial lung disease.Detailed profiles of ADC-related interstitial lung disease cases were collected for 76 quarters.The demographic characteristics were examined.RESULTS A total of 104,159 adverse event reports were extracted with 8 ADC drugs as the primary suspected drugs.There were 1,232 reports of interstitial lung disease-associated adverse events.Seven ADC signals were identified as trastuzumab deruxtecan(TD,ROR=38.35,IC=4.94);brentuximab vedotin(BV,ROR=5.25,IC=2.17);enfortumab vedotin(EV,ROR=4.97,IC=1.82);polatuzumab vedotin(PV,ROR=3.80,IC=1.55);ado-trastuzumab emtansine(T-DM1,ROR=3.71,IC=1.67);gemtuzumab ozogamicin(GO,ROR=2.68,IC=1.35)and sacituzumab govitecan(SG,ROR=1.98,IC=0.41).Case fatality outcome report for adverse events of interstitial lung disease:There were TD(n=104,26.20％),BV(n=51,23.97％),EV(n=14,30.43％),PV(n=16,22.86％),T-DM1(n=36,17.56％),SG(n=1,3.70％),GO(n=23,69.70％)and inotuzumab ozogamicin(IO)(n=3,33.33％).Analysis of occurrence time of related adverse events:the number of events at Day 1 of BV treatment accounted for ≥10％of total number of cases;median time of interstitial lung disease-like events of BV,IO,EV,PV and SG was between 1 and 3 courses of dosing(21-63 days).CONCLUSION Higher attention should be paid to the risk of ADC drug-related lung injury events.And clinical medication monitoring should be strengthened for minimizing the impact of adverse reactions on patient out-come and quality-of-life.
antibody-drug conjugateinterstitial lung diseaseFAERSdata miningadverse reactions study
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