To evaluate the long-term safety profile of ponatinib and the effect of post-approval risk management measures (RMMs) on adverse event reporting rates.
Approach:
Data Collection: Analyzed 10 years of real-world data from the Incyte Global Safety Database, focusing on important identified risks (IIRs) of ponatinib.
Adverse Event Reporting: Identified adverse events (AEs) related to ponatinib's IIRs reported globally between December 2012 and December 2022.
Key Findings:
A total of 9067 adverse events (AEs) were reported for ten analyzed important identified risks (IIRs) over 29,682 patient-years.
The reporting rate of total IIRs was highest in the first year (2.369) and declined to 0.219 by the last interval.
Interpretation:
The implementation of RMMs has been associated with a decrease in the reporting rates of ponatinib's important identified risks.
Limitations:
Data may be influenced by reporting biases and the nature of spontaneous reporting.
Estimation of post-marketing exposure may not account for all patient variables.
Conclusion:
Real-world data indicates changes in the safety profile of ponatinib over a decade.
