| Etanercept | Tocilizumab | IL-1 inhibitors | |||||
---|---|---|---|---|---|---|---|---|
n = 143; 355.8PY | Rate per patient year (95&CI) | n = 72; 111.6PY | Rate per patient year (95&CI) | Rate per patient year (95&CI)a | n = 60; 116.8PY | Rate per patient year (95&CI) | Rate per patient year (95&CI)a | |
AE | 71 | 0.20 (0.16–0.25) | 118 | 1.06 (0.88–1.27) | 5.3 (3.9–7.1) p < 0.0001 | 81 | 0.69 (0.56–0.86) | 3.5 (2.5–4.7) p > 0.05 |
SAE | 18 | 0.05 (0.03–0.08) | 14 | 0.13 (0.07–0.21) | 2.5 (1.2–5.0) p = 0.01 | 17 | 0.15 (0.07–0.21) | 2.9 (1.5–5.6) P = 0.002 |
JIA-Reactivation | 4 | 0.01 (0.00–0.03) | 7 | 0.06 (0.03–1.31) | 5.6 (1.6–19.1) p = 0.006 | 10 | 0.86 (0.05–0.16) | 7.6 (2.4–24.3) p = 0.0006 |
MAS | 3 | 0.01 (0.00–0.03) | 5 | 0.05/0.02–0.11) | 5.3 (1.2–22.2) p = 0.02 | 3 | 0.03 (0.01–0.08) | 3.0 (0.6–15.1) p > 0.05 |
hypersensitivity | 5 | 0.01 (0.01–0.03) | 4 | 0.04 (0.01–0.10) | 2.6 (0.7–9.5) p > 0.05 | 2 | 0.02 (0.00–0.07) | 1.2 (0.2–6.3) p > 0.05 |
infections | 16 | 0.05 (0.03–0.08) | 55 | 0.49 (0.38–0.64) | 11.0 (6.3–19.1) p < 0.0001 | 39 | 0.33 (0.24–0.46) | 7.4 (4.1–13.3) p < 0.0001 |
neutropenia | 1 | 0.00 (0.00–0.02) | 6 | 0.05 (0.02–0.12) | 19.1 (2.3–158) p = 0.006 | 1 | 0.01 (0.00–0.06) | 3.0 (0.2–48.7) p > 0.05 |
thrombocytopenia | 1 | 0.00 (0.00–0.02) | 1 | 0.01 (0.00–0.06) | 3.2 (0.2–51) p > 0.05 | 1 | 0.01 (0.00–0.06) | 3.0 (0.2–48.7) p > 0.05 |
elevated Transaminases | 8 | 0.02 (0.01–0.45) | 4 | 0.04 (0.01–0.10) | 1.6 (0.5–5.3) p > 0.05 | 1 | 0.01 (0.00–0.06) | 0.4 (0.05–3.0) p > 0.05 |
hair loss | 4 | 0.01 (0.00–0.03) | 2 | 0.02 (0.00–0.07) | 1.6 (0.3–8.7) p > 0.05 | 0 |  |  |
skin signs and symptoms | 6 | 0.02 (0.01–0.03) | 3 | 0.03 (0.01–0.08) | 1.6 (0.4–6.4) p > 0.05 | 0 |  |  |
neurol. signs and symptoms | 3 | 0.01 (0.00–0.03) | 11 | 0.10 (0.05–1.78) | 11.7(3.3–42.0) p = 0.0001 | 0 |  |  |