Table 4.
Disease | Patients (n) | Total side effects (n) | Total infections (n) | Severe infections (n) | |||||
---|---|---|---|---|---|---|---|---|---|
Placebo | Biologic | Placebo | Biologic | Placebo | Biologic | Placebo | Biologic | ||
Meijer et al [3] | Sjögren síndrome | 10 | 20 | 4 | 16 | 4 | 11 | NS | NS |
Dass et al [4] | Sjögren síndrome | 9 | 8 | 0 | 4 | 0 | 1 | 0 | 1 |
Merrill et al [5] | SLE | 88 | 169 | 73 | 139 | 15 | 16 | 15 | 16 |
Stone et al [6] | ANCA-vasculitis | 98 | 99 | 33 | 31 | NS | NS | 7 | 7 |
Jones et al [7] | ANCA-vasculitis | 11 | 33 | NS | NS | 7 | 19 | 3 | 7 |
RITUXIMAB | 216 | 329 | 110/205 | 190/296 | 26/118 | 47/230 | 25/206 | 31/309 | |
HR 1.55 (1.06-2.26)* | HR 0.97 (0.80-1.17) | HR 0.81 (0.45-1.48) | |||||||
Hoffman et al [8] | Giant cell arteritis | 16 | 28 | 15 | 26 | 9 | 20 | 1 | 3 |
Salvarani et al [9] | Rheumatic polym. | 28 | 23 | 5 | 7 | 0 | 1 | 0 | 1 |
Baughman et al [10] | Sarcoidosis | 44 | 89 | 41 | 80 | 32 | 54 | 4 | 10 |
Mariette et al [11] | Sjögren síndrome | 49 | 54 | 1 | 6 | 0 | 1 | 0 | 1 |
INFLIXIMAB | 137 | 194 | 62 (45.2% | 119 (61.3%) | 41 | 76 | 5 | 15 | |
HR 1.92 (1.20-3.06)* | HR 1.51 (0.92-2.47) | HR 2.21 (0.74-7.96) | |||||||
Melikoglu et al [12] | Behcet | 20 | 20 | 0 | 2 | 0 | 0 | 0 | 0 |
Baughman et al [13] | Sarcoidosis | 9 | 9 | 5 | 2 | 2 | 2 | 0 | 0 |
Sankar et al [14] | Sjögren syndrome | 14 | 14 | 1 | 2 | 1 | 0 | 0 | 0 |
WGET [15] | ANCA-vasculitis | 91 | 89 | 51 | 51 | 45 | 44 | NS | NS |
Mtnez-Taboada et al [16] | Giant cell arteritis | 9 | 8 | 7 | 8 | 4 | 4 | 0 | 0 |
ETANERCEPT | 143 | 140 | 64 (44.7%) | 65 (46.4%) | 52 (36.4%) | 50 (35.7%) | 0 (0%) | 0 (0%) | |
HR 1.07 (0.65-1.75) | HR 0.97 (0.58-1.63) | Not calculable | |||||||
TOTAL | 496 | 663 |
236/485 (48.7%) |
374/630 (59.4%) |
119/398 (29.9%) |
173/564 (30.7%) |
30/395 (7.6%) |
46/554 (8.3%) |
|
HR 1.54 (1.20-1.97)* | HR 1.04 (0.78-1.39) | HR 1.10 (0.67-1.84) |
*P < 0.05; ANCA, anti-neutrophil antibodies; HR, hazard ratio; NS, not specified; SLE, systemic lupus erythematosus.