Table 3.
Safety assessment: adverse event (AE) reports
| Etanercept, 5988PY | Biologic-naïve, 3782PY | RR (95% CI) | p† | |
|---|---|---|---|---|
| E/E/100PY (95% CI) | E/E/100PY (95% CI) | |||
| AE | 2053/34.3 (32.8–35.8) | 1345/35.6 (33.7–37.5) | 1.0 (0.9–1.03) | 0.3 |
| SAE | 226/3.8 (3.3–4.3) | 52/1.4 (1.1–1.8) | 2.8 (2.0–3.7) | 0.0001* |
| Serious infection | 54/0.9 (0.7–1.2) | 8/0.2 (0.1–0.4) | 4.3 (2.0–9.0) | 0.0001* |
| Herpes zoster | 24/0.4 (0.3–0.6) | 4/0.1 (0.04–0.3) | 3.8 (1.3–10.9) | 0.01* |
| Neutropenia | 4/0.07 (0.03–0.18) | 2/0.05 (0.01–0.2) | 1.3 (0.2–6.9) | 0.8 |
| MAS | 2/0.03 (0.008–0.3) | 1/0.03 (0.004–0.19) | 1.3 (0.1–13.9) | 0.9 |
| High transaminases | 97/1.6 (1.3–2.0) | 175/4.6 (4.0–5.4) | 0.4 (0.3–0.5) | 0.0001* |
| IBD | 19/0.3 (0.2–0.5) | 1/0.03 (0.004–0.19) | 12.0 (1.6–89.7) | 0.015* |
| Uveitis | 113/1.9 (1.6–2.3) | 54/1.4 (1.1–1.9) | 1.3 (0.96–1.8) | 0.09 |
| Psoriasis | 4/0.07 (0.03–0.18) | 1/0.03 (0.004–0.19) | 2.5 (0.3–22.6) | 0.4 |
| Demyelination | 1/0.02 (0.002–0.1) | 0/n.a. | n.a. | n.a. |
| Depression | 15/0.25 (0.2–0.4) | 2/0.05 (0.01–0.2) | 4.7 (1.1–20.7) | 0.04* |
| Malignancy | 3/0.05 (0.02–0.2) | 2/0.05 (0.01–0.2) | 1.0 (0.2–5.7) | 0.95 |
| Death | 3/0.05 (0.02–0.2) | 1/ 0.03 (0.004–0.19) | 1.9 (0.2–18.2) | 0.6 |
PY patient-years, E event, E/100PY rate, CI confidence interval, RR risk ratio, SAE serious adverse event, MAS macrophage activation syndrome, IBD inflammatory bowel disease, n.a. not applicable
†By Wald’s test
*p < 0.05