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Table 3 Summary safety data from ASSURE [34]

From: Abatacept in the treatment of rheumatoid arthritis

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)
  1. 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.
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