Real-World Safety Characteristic of Iguratimod: A Pharmacovigilance Study Based on the Japanese Adverse Drug Event Report (JADER) Database.

The safety profiles of iguratimod in large cohorts are lacking. The clinical characteristics and time-to-onset of adverse events remain completely unclear. Our real-world study aims to provide more comprehensive data for the risk management of iguratimod in the actual application environment. All data of iguratimod were obtained from the Japanese Adverse Drug Event Report (JADER) database. Four disproportionality analysis methods were used to detect significant pharmacovigilance signals. The Weibull shape parameter test was used to analyze the time-to-onset of adverse events. In our study, a total of 1472 adverse events associated with iguratimod treatment were collected, which refers to 22 System Organ Class. Within the standardized MedDRA queries, 23 positive signals were detected; 55 preferred terms (PTs) were detected by all 4 disproportionality analysis methods; and 30 PTs associated with infection were gained. Fourteen PTs were not listed in the directions, including 5 potential tumor signals. The most-mentioned PT is interstitial lung disease. Close to half of the adverse events (48.74%) occurred in the first 3 months of iguratimod treatment. The Weibull shape parameter test results showed that all of the disproportionality signals had an early failure-type profile, but infective signals present a random failure profile. This pharmacovigilance study provides valuable information for risk monitor and management of iguratimod, which helps enhance the safety of the clinical application.