A pharmacovigilance study on drug-induced liver injury associated with antibody-drug conjugates (ADCs) based on the food and drug administration adverse event reporting system

References

• Sievers EL, Senter PD. Antibody-drug conjugates in cancer therapy. Annu Rev Med. 2013;64(1):15–29. doi: 10.1146/annurev-med-050311-201823
   PubMedGoogle Scholar
• Chau CH, Steeg PS, Figg WD. Antibody-drug conjugates for cancer. Lancet. 2019;394(10200):793–804. doi: 10.1016/S0140-6736(19)31774-X
   PubMed Web of Science ®Google Scholar
• Mecklenburg L. A brief introduction to antibody-drug conjugates for toxicologic pathologists. Toxicol Pathol. 2018;46(7):746–752. doi: 10.1177/0192623318803059
   PubMed Web of Science ®Google Scholar
• Tsui CK, Barfeld RM, Fischer CR, et al. CRISPR-Cas9 screens identify regulators of antibody drug conjugate toxicity. Nat Chem Biol. 2019;15(10):949–958. doi: 10.1038/s41589-019-0342-2
   PubMed Web of Science ®Google Scholar
• Saber H, Simpson N, Ricks TK, et al. An FDA oncology analysis pf toxicities associated with PBD-containing antibody drug conjugates. Regul Toxicol Pharmacol. 2019;107:104429. doi: 10.1016/j.yrtph.2019.104429
   PubMed Web of Science ®Google Scholar
• Mahalingaiah PK, Ciurlionis R, Durbin KR, et al. Potential mechanisms of target-independent uptake and toxicity of antibody-drug conjugates. Pharmacol Ther. 2019;200:110–125. doi: 10.1016/j.pharmthera.2019.04.008
   PubMed Web of Science ®Google Scholar
• Lievano FA, Scarazzini LJ, Tyczynski JE, et al. Risk minimization of antibody-drug conjugates in oncology: a review. Drug Saf. 2021;44(7):733–742. doi: 10.1007/s40264-021-01069-9
   PubMed Web of Science ®Google Scholar
• Fontana R. Acute liver failure due to drugs. Semin Liver Dis. 2008;28(2):175–187. doi: 10.1055/s-2008-1073117
   PubMed Web of Science ®Google Scholar
• Saithanyamurthi H, Faust AJ. Drug-induced liver disease: clinical course. Clin Liver Dis. 2017;21(1):21–34. doi: 10.1016/j.cld.2016.08.007
   PubMed Web of Science ®Google Scholar
• Masters JC, Nickens DJ, Xuan D, et al. Clinical toxicity of antibody drug conjugates: a meta-analysis of payloads. Invest New Drugs. 2018;36(1):121–135. doi: 10.1007/s10637-017-0520-6
   PubMed Web of Science ®Google Scholar
• Nademanee A, Sureda A, Stif P, et al. Safety analysis of brentuximab vedotin from the phase III AETHERA trial in Hodgkin lymphoma in the posttransplant consolidation setting. Biol Blood Marrow Transplant. 2018;24(11):2354–2359. doi: 10.1016/j.bbmt.2018.05.026
   PubMed Web of Science ®Google Scholar
• Chen R, Palmer JM, Martin P, et al. Results of a multicenter phase II trial of brentuximab vedotin as second-line therapy before autologous transplantation in relapsed/refractory Hodgkin lymphoma. Biol Blood Marrow Transplant. 2015;21(12):2136–2140. doi: 10.1016/j.bbmt.2015.07.018
   PubMed Web of Science ®Google Scholar
• Diefenbach C, Kahl BS, McMillan A, et al. Polatuzumab vedotin plus obinutuzumab and lenalidomide in patients with relapsed or refractory follicular lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study. Lancet Haematol. 2021;8(12):e891–e901. doi: 10.1016/S2352-3026(21)00311-2
   Google Scholar
• von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617–628. doi: 10.1056/NEJMoa1814017
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019;125(14):2474–2487. doi: 10.1002/cncr.32116
   PubMed Web of Science ®Google Scholar
• Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: results of the randomized phase III EORTC-GIMEMA AML-19 trial. J Clin Oncol. 2016;34(9):972–979. doi: 10.1200/JCO.2015.64.0060
   PubMed Web of Science ®Google Scholar
• Banda JM, Evans L, Vanguri RS, et al. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci Data. 2016;3(1):160026. doi: 10.1038/sdata.2016.26
   PubMedGoogle Scholar
• Brinker AD, Lyndly J, Tonning J, et al. Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA adverse event reporting system (FAERS) database. Drug Saf. 2013;36(12):1169–1178. doi: 10.1007/s40264-013-0116-9
   PubMed Web of Science ®Google Scholar
• Böhm R, Bulin C, Waetzig V, et al. Pharmacovigilance-based drug repurposing: the search for inverse signals via OpenVigil identifies putative drugs against viral respiratory infections. Brit J Clinical Pharma. 2021;87(11):4421–4431. doi: 10.1111/bcp.14868
   PubMed Web of Science ®Google Scholar
• Wei CY, Liu Y, Jiang AD, et al. A pharmacovigilance study of the association between tetracyclines and hepatotoxicity based on Food and drug administration adverse event reporting system data. Int J Clin Pharm. 2022;44(3):709–716. doi: 10.1007/s11096-022-01397-5
   PubMed Web of Science ®Google Scholar
• Suzuki A, Yuen NA, Ilic K, et al. Comedications alter drug-induced liver injury reporting frequency: data mining in the WHO VigiBase™. Regul Toxicol Pharmacol. 2015;72(3):481–490. doi: 10.1016/j.yrtph.2015.05.004
   PubMed Web of Science ®Google Scholar
• Greten S, Muller-Funogea JI, Wegner F, et al. Drug safety profiles in geriatric patients with Parkinson’s disease using the FORTA (fit fOR The aged) classification: results from a mono-centric retrospective analysis. J Neural Transm (Vienna). 2021;128(1):49–60. doi: 10.1007/s00702-020-02276-x
   PubMed Web of Science ®Google Scholar
• Hoofnagle JH, Serrano J, Knoben JE, et al. LiverTox: a website on drug-induced liver injury. Hepatology. 2013;57(3):873–874. doi: 10.1002/hep.26175
   PubMed Web of Science ®Google Scholar
• Lambert J, Pautas C, Terré C, et al. Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial. Haematologica. 2019;104(1):113–119. doi: 10.3324/haematol.2018.188888
   PubMed Web of Science ®Google Scholar
• Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med. 2019;380(8):741–751. doi: 10.1056/NEJMoa1814213
   PubMed Web of Science ®Google Scholar
• Evan YY, Daniel PP, Peter HO, et al. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):872–882. doi: 10.1016/S1470-2045(21)00094-2
   PubMed Web of Science ®Google Scholar
• Tolaney SM, Tayob N, Dang C, et al. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol. 2021;39(21):2375–2385. doi: 10.1200/JCO.20.03398
   PubMed Web of Science ®Google Scholar
• Hurvitz SA, Hegg R, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. Lancet. 2023;401(10371):105–117. doi: 10.1016/S0140-6736(22)02420-5
   PubMed Web of Science ®Google Scholar
• Siena S, Bartolomeo MD, Raghav K, et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021;22(6):779–789. doi: 10.1016/S1470-2045(21)00086-3
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019;125(14):2474–2487. doi: 10.1002/cncr.32116
   PubMed Web of Science ®Google Scholar
• Caimi PF, Ai W, Alderuccio JP, et al. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):790–800. doi: 10.1016/S1470-2045(21)00139-X
   PubMed Web of Science ®Google Scholar
• Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020;21(2):207–221. doi: 10.1016/S1470-2045(19)30788-0
   PubMed Web of Science ®Google Scholar
• Kreitman RJ, Dearden C, Zinzani PL, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018;32(8):1768–1777. doi: 10.1038/s41375-018-0210-1
   PubMed Web of Science ®Google Scholar
• Abboud G, Kaplowitz K. Drug-induced liver injury. Drug Saf. 2007;30(4):277–294. doi: 10.2165/00002018-200730040-00001
   PubMed Web of Science ®Google Scholar
• Verma S, Kaplowitz N. Diagnosis, management and prevention of drug-induced liver injury. Gut. 2009;58(11):1555–1564. doi: 10.1136/gut.2008.163675
   PubMed Web of Science ®Google Scholar
• Fontana RJ. Pathogenesis of idiosyncratic drug-induced liver injury and clinical perspectives. Gastroenterology. 2014;146(4):914–928. doi: 10.1053/j.gastro.2013.12.032
   PubMed Web of Science ®Google Scholar
• Roth RA, Luyendyk JP, Maddox JF, et al. Inflammation and drug idiosyncrasy—is there a connection? J Pharmacol Exp Ther. 2003;307(1):1–8. doi: 10.1124/jpet.102.041624
   PubMed Web of Science ®Google Scholar
• Niknahad H, Heidari R, Firuzi R, et al. Concurrent Inflammation augments antimalarial drugs-induced liver injury in rats. Adv Pharm Bull. 2016;6(4):617–625. doi: 10.15171/apb.2016.076
   PubMed Web of Science ®Google Scholar
• Bernstein ID. Monoclonal antibodies to the myeloid stem cells: therapeutic implications of CMA-676, a humanized anti-CD33 antibody calicheamicin conjugate. Leukemia. 2000;14(3):474–475. doi: 10.1038/sj.leu.2401663
   PubMed Web of Science ®Google Scholar
• Bross PF, Beitz J, Chen G, et al. Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res June. 2001;7(6):1490–1496.
   PubMed Web of Science ®Google Scholar
• Petersdorf SH, Kopecky KJ, Slovak M, et al. A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia. Blood. 2013;121(24):4854–4860. doi: 10.1182/blood-2013-01-466706
   PubMed Web of Science ®Google Scholar
• Taksin AL, Legrand O, Raffoux E, et al. High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group. Leukemia. 2007;21(1):66–71. doi: 10.1038/sj.leu.2404434
   PubMed Web of Science ®Google Scholar
• Wang ES, Aplenc R, Chirnomas D, et al. Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2020;61(8):1965–1973. doi: 10.1080/10428194.2020.1742897
   PubMed Web of Science ®Google Scholar
• Deeks ED. Polatuzumab Vedotin: first global approval. Drugs. 2019;79(13):1467–1475. doi: 10.1007/s40265-019-01175-0
   PubMed Web of Science ®Google Scholar
• Daiichi Sankyo Inc (2019) Enhertu (fam-trastuzumab deruxtecan-nxki): US prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761139s000lbl.pdf. Accessed 2020.
   Google Scholar
• Chang E, Weinstock C, Zhang L, et al. FDA approval summary: enfortumab vedotin for locally advanced or metastatic urothelial carcinoma. Clin Cancer Res. 2021;27(4):922–927. doi: 10.1158/1078-0432.CCR-20-2275
   PubMed Web of Science ®Google Scholar
• Prince HM, Kim YH, Horwitz SM, et al. Brentuximab vedotin or physician’s choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017;390(10094):555–566. doi: 10.1016/S0140-6736(17)31266-7
   PubMed Web of Science ®Google Scholar
• Ocean AJ, Starodub AN, Bardia A, et al. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: safety and pharmacokinetics. Cancer. 2017;123(19):3843–3854. doi: 10.1002/cncr.30789
   PubMed Web of Science ®Google Scholar