EventBaseline Systemic Steroid Dose CategoryPBO + MTXAll CZP Doses
Incidence rate of AEs/100 pt-yrsIncidence rate of AEs/100 pt-yrs
Total AEsNone (PBO n=85; CZP n=320)276.16242.76
≤5 mg/day (PBO n=40; CZP n=204)192.88248.23
>5mg/day (PBO n=67; CZP n=246)247.15252.81
Total SAEsNone (PBO n=85; CZP n=320)2.7113.01
≤5 mg/day (PBO n=40; CZP n=204)17.3410.81
>5mg/day (PBO n=67; CZP n=246)23.1524.91
Serious Infections & InfestationsNone (PBO n=85; CZP n=320)03.21
≤5 mg/day (PBO n=40; CZP n=204)06.94
>5mg/day (PBO n=67; CZP n=246)6.3410.84