Abstract
The Immunosuppressive drug Bredinin® (mizoribine) was approved in 1992 for the indication of rheumatoid arthritis (RA) in Japan. Due to its safety profile, Bredinin® is widely used as a Disease Modifying Antirheumatic Drug in Japan. Four nationwide post-marketing surveillance studies were conducted in Japan by the drug originator Asahi Kasei Pharma to clarify the prescription patterns and safety profile of Bredinin®.
Adverse events were correlated by baseline weight, duration of RA, number of previous RA drugs, the American College of Rheumatology classification criteria for RA, and renal function. Stepwise multiple regression analysis was used to clarify the risk factors for adverse events.
Of the 6,375 patients registered, data collection and analysis for 6,309 participants is reported. The mean age of the participants was 62.9±11.9 years old, and 4,905 participants (77.8%) were women. Duration of RA, number of previous RA drugs, and lowered renal function each independently contributed to the incidence of adverse events.
The four studies in this surveillance showed that Bredinin® was mainly used to treat moderate RA and that the daily dose was generally decreased for patients with lower renal function. The analysis suggests that dose adjustments based on monitoring of renal function by measuring Ccr and the serum concentration of Bredinin® may be useful in improving the safety profile of Bredinin® for the treatment of RA.
