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Safety of daratumumab in the real-world: a pharmacovigilance study based on FAERS database

Junlin Wu1, Hanbiao Wu1, Lili Chen1

  • 1Key Specialty of Clinical Pharmacy, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong Province, China.

Expert Opinion on Drug Safety
|December 18, 2023
PubMed
Abstract

Insights

Daratumumab demonstrates a favorable safety profile in multiple myeloma and AL amyloidosis, with most adverse events (AEs) occurring early. New potential AEs require further investigation to confirm causality.

Area of Science:

  • Pharmacovigilance
  • Oncology
  • Hematology

Background:

  • Daratumumab is a key therapeutic agent for multiple myeloma (MM) and light chain amyloidosis (AL amyloidosis).
  • Assessing the safety profile of widely used drugs is crucial for patient care and treatment optimization.

Purpose of the Study:

  • To identify potential adverse event (AE) signals associated with daratumumab using the FDA Adverse Event Reporting System (FAERS) database.
  • To evaluate the safety of daratumumab in a large patient population.

Main Methods:

  • Disproportionality analysis methods, including reporting odd ratio (ROR), proportional reporting ratio (PRR), and Bayesian configuration promotion neural network (BCPNN), were employed.
  • Analysis was based on AE reports from the FAERS database where daratumumab was the primary suspect drug.

Main Results:

  • A total of 9,220 AE reports (23,946 AEs) were analyzed.
  • AE signals were detected across 252 preferred terms (PT), 73 high-level terms (HLT), and 11 system organ classes (SOC).
  • The majority of identified AEs occurred within the first month of daratumumab administration, and some novel AEs were identified.

Conclusions:

  • The study findings align with existing literature, indicating a generally good safety profile for daratumumab.
  • Newly identified potential AEs warrant further investigation through prospective clinical studies to establish a causal relationship.
  • This research provides an early warning system for daratumumab's safe usage and guides future safety research.
Keywords:
FAERSPharmacovigilanceadverse eventsdaratumumabdata miningdisproportionality analysis

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