Table 3 |
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|
Summary safety data from ASSURE [34] |
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|
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) |
|
|
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|
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) |
|
|
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|
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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|
Buch et al. Arthritis Research & Therapy 2008 10(Suppl 1):S5 doi:10.1186/ar2416 |
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