A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system

Zhihong Fang; Zhiqiang Xu; Wei Zhu; Mingming Yu; Chunmei Ji

doi:10.3389/fphar.2023.1101861

A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system

Front Pharmacol. 2023 Jun 5:14:1101861. doi: 10.3389/fphar.2023.1101861. eCollection 2023.

Authors

Zhihong Fang¹, Zhiqiang Xu², Wei Zhu², Mingming Yu³, Chunmei Ji²

Affiliations

¹ Department of General Surgery, The Affiliated Wuxi Children's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.
² Research Division of Clinical Pharmacology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
³ Department of Urology, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.

Abstract

Background: Apalutamide is a new drug class, which is approved to treat prostate cancer (PCa). The aim of our study was to assess the safety profiles of apalutamide in real-world through data mining of the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Method: We included adverse event (AE) reports regarding apalutamide submitted to the FAERS from 2018 quarter 1 (2018Q1) to 2022 quarter 1 (2022Q1). Disproportionality analyses, including reporting odds ratio (ROR), were performed to identify the signals of AEs in patients receiving apalutamide. A signal was detected if the lower limit of the 95% confidence interval (CI) of ROR >1 and at least 3 AEs were reported. Results: The FAERS database documented 4,156 reports regarding apalutamide from 1 January 2018, to 31 March 2022. A total of 100 significant disproportionality preferred terms (PTs) were retained. Frequently observed AEs in patients receiving apalutamide included rash, fatigue, diarrhea, hot flush, fall, weight decreased, hypertension. The most significant system organ class (SOC) was "skin and subcutaneous tissue disorders", which mainly consisted of dermatological adverse events (dAEs). The additional AEs observed with the significantly signal contain lichenoid keratosis, increased eosinophil count, bacterial pneumonia, pulmonary tuberculosis, hydronephrosis. Conclusion: Our findings provide valuable evidence for apalutamide safety profile in the real-world, which could help clinicians and pharmacists to enhance their vigilance and improve the safety of apalutamide in clinical practice.

Keywords: FDA adverse event reporting system; adverse event; apalutamide; disproportionality analyses; real-world.