Table 6.

Summary of safety data from abatacept studies

	Open-label, lead-in and controlled withdrawal phases	Open-label, long-term extension
Number of patients	190	153
Study length (months)	10	35 (47.8 maximum)
Patient-year exposure	NA	NA
Adverse events (total)	170	NA
Serious adverse events (total)	6	23
Adverse events leading to drug discontinuation	1	3
Infusion reactions	9	15 (5 patients)
Anaphylaxis-like reactions	0	2
Infections (total)	95	NA
Serious infections	1	6
Mycobacterium infections	0	0
Other opportunistic infections	0	1
Autoimmune phenomena (total)	0	0
Uveitis	0	1
Demyelinating events	0	1
“Lupus-like” syndrome	0	0
Autoantibodies	14	4
Antibodies to medication	NA	17
Malignancies (total)	1*	0
Deaths	0	0

Note:

^*Malignancy may have been prior to treatment and patient was misdiagnosed with juvenile idiopathic arthritis.

Adapted from Hashkes et al.15

Abbreviation: NA, not available.