Table 1.

Overview of Observational Adverse Events (AEs)

MTX (N=306)ADA (N=459)
Any AE125 (40.8)142 (30.9)
At least “possibly drug related” per the investigator63 (20.6)71 (15.5)
Severe AE12 (3.9)22 (4.8)
Serious AE16 (5.2)30 (6.5)
AE leading to discontinuation of study drug23 (7.5)25 (5.4)
Infectious AE64 (20.9)80 (17.4)
Serious infectious AE7 (2.3)12 (2.6)
Injection site-related AE3 (1.0)20 (4.4)