Table 3.
Summary of TEAEs from baseline to week 52
| Number of patients (% of patients) [events] IR (95% CI) |
CZP 400 mg Q2W (n = 64) Patient exposure: 62.9 PY |
CZP 200 mg Q2Wa (n = 72) Patient exposure: 63.5 PY |
All CZP (N = 122) Patient exposure: 126.5 PY |
|---|---|---|---|
| Any TEAE |
54 (84.4) [187] 261.0 (196.1–340.5) |
63 (87.5) [230] 352.7 (271.0–451.3) |
111 (91.0) [417] 307.5 (252.9–370.3) |
| Most commonly reported TEAE (PT ≥ 10% in All CZP group) | |||
| Nasopharyngitis |
28 (43.8) [48] 64.1 (42.6–92.6) |
25 (34.7) [30] 49.1 (31.8–72.5) |
53 (43.4) [78] 56.7 (42.5–74.2) |
| Psoriasis |
5 (7.8) [5] 8.1 (2.6–18.9) |
8 (11.1) [8] 13.1 (5.7–25.9) |
13 (10.7) [13] 10.6 (5.7–18.2) |
| Serious TEAEs |
6 (9.4) [7] 10.1 (3.7–22.1) |
2 (2.8) [2] 3.2 (0.4–11.5) |
8 (6.6) [9] 6.6 (2.8–12.9) |
| Blood and lymphatic system disorders |
1 (1.6) [1] 1.6 (0.0–8.9) |
1 (1.4) [1] 1.6 (0.0–8.9) |
2 (1.6) [2] 1.6 (0.2–5.8) |
| Neutropenia | 0 |
1 (1.4) [1] 1.6 (0.0–8.9) |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Thrombocytopenia |
1 (1.6) [1] 1.6 (0.0–8.9) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Eye disorders |
1 (1.6) [1] 1.6 (0.0–8.9) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Eyelid ptosis |
1 (1.6) [1] 1.6 (0.0–8.9) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Gastrointestinal disorders |
1 (1.6) [1] 1.6 (0.0–9.0) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Large intestine polyp |
1 (1.6) [1] 1.6 (0.0–9.0) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Immune system disorders | 0 |
1 (1.4) [1] 1.6 (0.0–8.8) |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Sarcoidosis | 0 |
1 (1.4) [1] 1.6 (0.0–8.8) |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Infections and infestations |
2 (3.1) [3] 3.3 (0.4–11.8) |
0 |
2 (1.6) [3] 1.6 (0.2–5.8) |
| Herpes zoster |
1 (1.6) [1] 1.6 (0.0–9.0) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Latent tuberculosis |
2 (3.1) [2] 3.3 (0.4–11.7) |
0 |
2 (1.6) [2] 1.6 (0.2–5.8) |
| Skin and subcutaneous tissue disorders |
1 (1.6) [1] 1.6 (0.0–8.9) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Henoch–Schonlein purpura |
1 (1.6) [1] 1.6 (0.0–8.9) |
0 |
1 (0.8) [1] 0.8 (0.0–4.4) |
| Discontinuation due to TEAEs | 4 (6.3) [4] | 5 (6.9) [5] | 9 (7.4) [9] |
| Drug-related TEAEs | 18 (28.1) [34] | 21 (29.2) [43] | 39 (32.0) [77] |
| Severe TEAEs | 4 (6.3) [4] | 3 (4.2) [3] | 7 (5.7) [7] |
| Deaths | 0 | 0 | 0 |
Safety set. TEAEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) v.18.1. Only two patients continued placebo treatment to week 52; therefore, placebo data are not shown. Patients who received both CZP 200 mg Q2W and CZP 400 mg Q2W are included once in the population count for the All CZP group. aPatients may receive either CZP 200 mg Q2W or CZP 400 mg Q4W during the maintenance treatment period
CI confidence interval, CZP certolizumab pegol, IR incidence rates, PT preferred term, PY patient year, Q2W every 2 weeks, Q4W every 4 weeks, TEAE treatment-emergent adverse events