Table 2.
Overall summary of treatment‐emergent adverse events (TEAEs) in patients treated with certolizumab pegol (CZP)
| All CZP (N = 995) | CZP 200 mg Q2W (N = 731) | CZP 400 mg Q2W (N = 728) | |
|---|---|---|---|
| Total exposure, PY | 2231·3 | 1211·4 | 1019·9 |
| Exposure (days) | |||
| Mean ± SD | 768·1 ± 314·0 | 569·7 ± 328·6 | 477·7 ± 306·3 |
| Median (range) | 897·0 (14·0–1035·0) | 671·0 (12·0–1022·0) | 343·0 (12·0–1014·0) |
| n (%)a | IR/100 PY (95% CI) | n (%)a | IR/100 PY (95% CI) | n (%)a | IR/100 PY (95% CI) | |
|---|---|---|---|---|---|---|
| All TEAEs | 847 (85·1) | 144·9 (135·3–155·0) | 557 (76·2) | 134·1 (123·2–145·7) | 563 (77·3) | 158·3 (145·5–171·9) |
| Mild | 700 (70·4) | 81·7 (75·8–88·0) | 436 (59·6) | 76·7 (69·7–84·3) | 446 (61·3) | 88·8 (80·8–97·5) |
| Moderate | 627 (63·0) | 52·7 (48·6–57·0) | 395 (54·0) | 53·6 (48·4–59·1) | 373 (51·2) | 59·9 (54·0–66·3) |
| Severe | 132 (13·3) | 6·3 (5·3–7·5) | 66 (9·0) | 5·7 (4·4–7·2) | 70 (9·6) | 7·2 (5·6–9·1) |
| TEAEs leading to death | 7 (0·7) | 0·3 (0·1–0·7) | 4 (0·5) | 0·3 (0·1–0·9) | 3 (0·4) | 0·3 (0·1–0·9) |
| SAEs | 154 (15·5) | 7·5 (6·4–8·8) | 76 (10·4) | 6·7 (5·2–8·3) | 82 (11·3) | 8·7 (6·9–10·8) |
| TEAEs leading to discontinuation | 88 (8·8) | 4·0 (3·2–4·9) | 41 (5·6) | 3·4 (2·5–4·6) | 48 (6·6) | 4·7 (3·5–6·3) |
| Drug‐related TEAEs | 264 (26·5) | 14·6 (12·9–16·5) | 151 (20·7) | 14·6 (12·4–17·2) | 148 (20·3) | 16·9 (14·3–19·9) |
Patients who received both CZP 200 mg every 2 weeks (Q2W) and CZP 400 mg Q2W are included once in the population count for the ‘all CZP’ group. CI, confidence interval; IR, incidence rate; PY, patient‐years; SD, standard deviation; SAE, serious TEAE. aThe number of patients who reported at least one TEAE in the category.