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

ABSTRACT

Background

Daratumumab is widely used in multiple myeloma (MM) and light chain amyloidosis (AL amyloidosis). The purpose of this study was to identify adverse event (AE) signals for daratumumab through the FDA Adverse Event Reporting System (FAERS) database to assess its safety in a large sample of people.

Methods

Based on data from the FAERS database, three disproportionality analysis methods were used to mine AE signals for daratumumab, including reporting odd ratio (ROR), proportional reporting ratio (PRR), and bayesian configuration promotion neural network (BCPNN).

Results

A total of 9220 AE reports with daratumumab as the primary suspect drug were collected, containing 23,946 AEs. Within these reports, 252 preferred terms (PT) levels, 73 high level term (HLT) levels and 11 system organ class (SOC) levels of AE signals were detected, along with some new AEs. Most AEs occurred within the first month after drug administration.

Conclusion

Our findings were consistent with the results of established studies that daratumumab has a good safety profile. The newly identified AEs are of concern and prospective clinical studies are needed to confirm whether they are causally related to daratumumab. This study provided an early warning for the safe use of daratumumab and also provided guidance for further safety studies.

KEYWORDS:

• Pharmacovigilance
• data mining
• adverse events
• disproportionality analysis
• FAERS
• daratumumab

Abbreviations

AE	=	Adverse Event
AL amyloidosis	=	Light Chain Amyloidosis
BCPNN	=	Bayesian Configuration Promotion Neural Network
FAERS	=	FDA Adverse Event Reporting System
IC	=	Information Component
IRRs	=	Infusion-Related Reactions
MedDRA	=	Medical Dictionary for Regulatory Activities
MM	=	Multiple Myeloma
PRR	=	Proportional Reporting Ratio
PT	=	Preferred Terms
ROR	=	Reporting Odd Ratio
SOC	=	System Organ Class

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributions

All authors were involved in the conception and design, or analysis and interpretation of the data as well as the drafting and revising of the paper. All authors agree to be accountable for all aspects of the work.

Acknowledgments

This study was supported by National Key Clinical Specialty Construction Project (Clinical Pharmacy) and High-Level Clinical Key Specialty (Clinical Pharmacy) in Guangdong Province.

Data availability statement

All data used in this study are available in the FAERS database: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2296966.

Additional information

Funding

This paper was not funded.