Table 3

Summary safety data from ASSURE [34]

Number of events (%)

Abatacept plus nonbiologic DMARD (n = 856)

Placebo plus nonbiologic DMARD (n = 418)

Abatacept plus biologic DMARD (n = 103)

Placebo plus biologic DMARD (n = 64)


Death

5 (0.6)

4 (1.0)

0

0

Total adverse events

768 (89.7)

360 (86.1)

98 (95.1)

57 (89.1)

Serious adverse events

100 (11.7)

51 (12.2)

23 (22.3)

8 (12.5)

Discontinuations because of adverse events

43 (5.0)

18 (4.3)

9 (8.7)

2 (3.1)

Serious infection

22 (2.6)

7 (1.7)

6 (5.8)

1 (1.6)

Neoplasm (benign/malignant)

27 (3.2)

16 (3.8)

7 (6.8)

1 (1.6)


Number (%) of events are included for abatacept and placebo in combination with either nonbiologic DMARD or biologic DMARD at 1 year. ASSURE, Abatacept Study of Safety in Use with other Rheumatoid arthritis thErapies; DMARD, disease-modifying antirheumatic drug.

Buch et al. Arthritis Research & Therapy 2008 10(Suppl 1):S5   doi:10.1186/ar2416