Mining of adverse event signals of polatuzumab vedotin based on FAERS

doi:10.19803/j.1672-8629.20240215

Abstract

Abstract: Objective To mine information from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze adverse reaction signals of polatuzumab vedotin for clinical use. Methods The reports in the FAERS database collected between January 1, 2004 and June 30, 2023 were screened using SAS 9.4, and the signal values of the screened data were calculated by using the reporting odds ratio (ROR) and information component (IC) before being assessed according to the signal detection criteria. Results The number of reports that screened polatuzumab vedotin as the primary suspect drug (PS) was 636. After such signals were excluded as product defects, surgical and medical procedures and primary disease, 233 cases of positive polatuzumab vedotin-related AD signals were recorded. The ADE signals that ranked high in terms of the number of reported cases included off-label use, COVID-19, pyrexia, platelet count decreases and cytopenia. Among them, such signals as COVID-19, renal impairment and cardiac failure were not included in the labels. ADE signals with higher strength included subclavian vein stenosis, cytomegalovirus gastrointestinal ulcer and olfactory dysfunction, but subclavian vein stenosis and olfactory dysfunction were not included in the labels. Conclusion The suspicious signals for polatuzumab vedotin mined so far are generally consistent with those specified in the instructions. The use of polatuzumab vedotin requires not only close attention to such adverse reactions mentioned in the label as neutropenia, thrombocytopenia and peripheral neuropathy, but vigilance to potential ADE, such as renal failure, cardiac failure, thromboembolism, and COVID-19 infection. Blood test, cardiac and renal function should be closely monitored. Abnormalities of sensory nerves, motor nerves and autonomic nerves have to be observed. Immediate preventive and curative measures are needed to reduce the risk of clinical medications when necessary.

Key words: polatuzumab vedotin, adverse drug events, safety, data mining, FAERS

CLC Number:

GU Chenchen, ZONG Liuliu, YAO Yamin, SHEN Jie. Mining of adverse event signals of polatuzumab vedotin based on FAERS[J]. Chinese Journal of Pharmacovigilance, 2024, 21(10): 1159-1165.

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https://zgywjj.magtechjournal.com/EN/Y2024/V21/I10/1159

References

[1] ASSI R, MASRI N, DALLE IA, et al.Polatuzumab vedotin: current role and future applications in the treatment of patients with diffuse large B-cell lymphoma[J]. Clin Hematol Int, 2021, 3(1): 21-26.
[2] TANG L, SUN C, LIU W, et al.A pharmacovigilance study on antibody-drug conjugate (ADC)-related neurotoxicity based on the FDA adverse event reporting system (FAERS)[J]. Front Pharmacol, 2024, 15: 1362484.
[3] DEEKS ED.Correction to: polatuzumab vedotin: first global approval[J]. Drugs, 2021, 79(16): 1829.
[4] SUN C, YANG X, TANG L, et al.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[J]. Expert Opin Drug Saf, 2023, 10: 1-12.
[5] VAN PE, BATE A, LEUFKENS HG, et al.A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions[J]. Pharmacoepidemiol Drug Saf, 2002, 11(1): 3-10.
[6] EVANS SJ, WALLER PC, DAVIS S.Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports[J]. Pharmacoepidemiol Drug Saf, 2001, 10(6): 483-486.
[7] ZHANG JY, BAI YX, HAN S, et al.Application of data mining algorithm to detect adverse drug reaction signal[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2016, 18(6): 412-416.
[8] BATE A, LINDQUIST M, EDWARDS IR, et al.A bayesian neural network method for adverse drug reaction signal generation[J]. Eur J Clin Pharmacol, 1998, 54(4): 315-321.
[9] WANG SS.Epidemiology and etiology of diffuse large B-cell lymphoma[J]. Semin Hematol, 2023, 60(5): 255-266.
[10] MAHALINGAIAH PK, CIURLIONIS R, DURBIN KR, et al.Potential mechanisms of target-independent uptake and toxicity of antibody-drug conjugates[J]. Pharmacol Ther, 2021, 200: 110-125.
[11] OAK E, BARTLETT NL.A safety evaluation of brentuximab vedotin for the treatment of Hodgkin lymphoma[J]. Expert Opin Drug Saf, 2016, 15(6): 875-882.
[12] OKELEY NM, MIYAMOTO JB, ZHANG X, et al.Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate[J]. Clin Cancer Res, 2010, 16(3): 888-897.
[13] HARPER J, MAO S, STROUT P, et al.Selecting an optimal antibody for antibody-drug conjugate therapy: internalization and intracellular localization//DUCRY L. Antibody-Drug Conjugates[M]. Visp: Lonza Ltd., 2013: 41-49.
[14] HINRICHS MJ, DIXIT R.Antibody drug conjugates: nonclinical safety considerations[J]. Aaps J, 2015, 17(5): 1055-1064.
[15] DOSIO F, BRUSA P, CATTEL L.Immunotoxins and anticancer drug conjugate assemblies: the role of the linkage between components[J]. Toxins (Basel), 2011, 3(7): 848-883.
[16] DONAGHY H.Effects of antibody, drug and linker on the preclinical and clinical toxicities of antibody-drug conjugates[J]. MAbs, 2016, 8(4): 659-671.
[17] ZHAO H, GULESSERIAN S, GANESAN SK, et al.Inhibition of megakaryocyte differentiation by antibody-drug conjugates (ADCs) is mediated by macropinocytosis: implications for ADC-induced thrombocytopenia[J]. Mol Cancer Ther, 2017, 16(9): 1877-1886.
[18] ZEUNER A, SIGNORE M, MARTINETTI D, et al.Chemotherapy-induced thrombocytopenia derives from the selective death of megakaryocyte progenitors and can be rescued by stem cell factor[J]. Cancer Res, 2007, 67(10): 4767-4773.
[19] ARGYRIOU AA, KOLTZENBURG M, POLYCHRONOPOULOS P, et al.Peripheral nerve damage associated with administration of taxanes in patients with cancer[J]. Crit Rev Oncol Hematol, 2008, 66(3): 218-228.
[20] HOLZBAUR EL, SCHERER SS.Microtubules, axonal transport, and neuropathy[J]. New Engl J Med, 2011, 365(24): 2330-2332.
[21] FU Z, GAO C, WU T, et al.Peripheral neuropathy associated with monomethyl auristatin E-based antibody-drug conjugates[J]. iScience, 2023, 26(10): 107778.
[22] ABRISQUETA P, GONZÁLEZ-BARCA E, PANIZO C, et al. Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study[J]. Lancet Haematol, 2024, 11(2): e136-e146.
[23] STEWART AK, KRISHNAN AY, SINGHAL S, et al.Phase I study of the anti-FcRH5 antibody-drug conjugate DFRF4539A in relapsed or refractory multiple myeloma[J]. Blood Cancer J, 2021, 9(2): 17.
[24] LI D, LEE D, DERE RC, et al.Evaluation and use of an anti-cynomolgus monkey CD79b surrogate antibody-drug conjugate to enable clinical development of polatuzumab vedotin[J]. Br J Pharmacol, 2021, 176(19): 3805-3818.
[25] LIAO M, LU D, LU T, et al.Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings[J]. Adv Drug Deliv Rev, 2024, 207: 115193.
[26] LYNCH RC, POH C, UJJANI CS, et al.Polatuzumab vedotin with infusional chemotherapy for untreated aggressive B-cell non-Hodgkin lymphomas[J]. Blood Adv, 2023, 7(11): 2449-2458.
[27] KINOSHITA T, HATAKE K, YAMAMOTO K, et al.Safety and pharmacokinetics of polatuzumab vedotin in Japanese patients with relapsed/refractory B-cell non-Hodgkin lymphoma: a phase 1 dose-escalation study[J]. Jap J Clin Oncol, 2021, 51(1): 70-77.
[28] DUVIC M, TETZLAFF MT, GANGAR P, et al.Results of a phase II trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis[J]. J Clin Oncol, 2015, 33(32): 3759-3765.
[29] BUDDE LE, OLSZEWSKI AJ, ASSOULINE S, et al.Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial[J]. Nat Med, 2024, 30(1): 229-239.
[30] 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[J]. Lancet Haematol, 2021, 8(12): e891-e901.
[31] SONG Y, TILLY H, RAI S, et al.Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial[J]. Blood, 2023, 141(16): 1971-1981.
[32] RODRÍGUEZ Y, ROJAS M, PACHECO Y, et al. Guillain-Barré syndrome, transverse myelitis and infectious diseases[J]. Cell Mol Immunol, 2018, 15(6): 547-562.
[33] JAÉN C, MAUTE C, MACKIN S, et al. Remote olfactory assessment using the NIH toolbox odor identification test and the brain health registry[J]. PLoS One, 2024, 19(4): 1-10 .
[34] AMANATI A, ZEKAVAT OR, FOROUTAN H, et al.Case reports of invasive mucormycosis associated neutropenic enterocolitis in leukemic children: diagnostic and treatment challenges and review of literature[J]. BMC Infect Dis, 2021, 21(1): 1268.
[35] Society Chinese Hernia College of Surgeons. Guidelines for diagnosis and treatment on the adult groin hernia(2018 edition)[J]. Chinese Journal of Surgery(中华外科杂志), 2018, 56(7): 495-498.
[36] LU C, CHEN Q, TAO H, et al.The causal effect of inflammatory bowel disease on diffuse large B-cell lymphoma: two-sample Mendelian randomization study[J]. Front Immunol, 2023, 14: 1171446.
[37] YANG X, LI GH.A study on the analysis of the causes of intravenous fluid extravasation and related preventive initiatives[J]. Jilin Medical Journal(吉林医学), 2014, 35(18): 4079.
[38] QI YP.Introduction to the causes of intravenous fluid extravasation and treatment measures[J]. Proceeding of Clinical Medicine(临床医药实践), 2014, 23(6): 461-462.
[39] PALMER L, BRIGGS C, MCFADDEN S, et al.ICSH recommendations for the standardization of nomenclature and grading of peripheral blood cell morphological features[J]. Int J Lab Hematol, 2015, 37(3): 287-303.
[40] CONTOU D, DE PN.Purpura fulminans in adult patients[J]. Rev Prat, 2023, 73(1): 71-78.
[41] CHAI YH, ZHANG YL, LIU F, et al.Progress in the study of the mechanism of postoperative intestinal obstruction[J]. Chinese Journal of General Surgery(中华普通外科杂志), 2023, 38(9): 713-716.
[42] Consensus Workgroup on Herpes Zoster China Dermatologist Association, Diseases National Clinical Research Center for Skin and Immune. Chinese consensus on the diagnosis and management of herpes zoster(2022)[J]. Chinese Journal of Dermatology(中华皮肤科杂志), 2022, 55(12): 1033-1040.