New Function for Safety Signal Monitoring in MID-NET®: The Case of an Anti-COVID-19 Drug

Real-world data play a key role in monitoring drug safety at the post-marketing stage. However, challenges on how to rapidly and continuously obtain analytical results of many outcomes for drug safety signal monitoring still remain. We aimed to establish a rapid and continuous monitoring tool for drug safety assessment based on real-world data in Japan. An automated process for a new-user cohort design with customizable analytical conditions was developed. The customizable analytical conditions include exposure and control drugs, 46 outcomes related to liver and kidney functions, blood tests, biomarkers, and time period of interest. Statistical analyses were performed to evaluate the outcome status (present/absent) and calculate the adjusted hazard ratio, with a 95% confidence interval of exposure to control. We monitored the safety signals of an anti-COVID-19 drug (combination of tixagevimab and cilgavimab) and compared them with those of two controls (peramivir and the combination of casirivimab and imdevimab) to examine the practical utility of this new tool. Our study provided helpful information (e.g., new safety signals) on many outcomes at multiple time points, which could enhance the understanding of drug safety profiles soon after approval. Our function can be used to rapidly and continuously monitor drug safety signals and contribute to strengthening drug safety monitoring in Japan.