Table 4.
Most frequent treatment‐emergent adverse events (TEAEs) [reported in > 5% of all patients treated with certolizumab pegol (CZP)] by MedDRA system organ class and preferred term
| 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 |
|
System organ classa Preferred terma |
n (%)c | IR/100 PY (95% CI) | n (%)c | IR/100 PY (95% CI) | n (%)c | IR/100 PY (95% CI) |
|---|---|---|---|---|---|---|
| Infections and infestations | 646 (64·9) | 59·1 (54·6–63·8) | 406 (55·5) | 60·8 (55·0–67·0) | 385 (52·9) | 63·3 (57·1–69·9) |
| Bronchitis | 57 (5·7) | 2·7 (2·0–3·4) | 29 (4·0) | 2·5 (1·7–3·5) | 30 (4·1) | 3·0 (2·0–4·3) |
| Nasopharyngitis | 251 (25·2) | 14·2 (12·5–16·0) | 144 (19·7) | 14·2 (12·0–16·7) | 152 (20·9) | 17·7 (15·0–20·8) |
| Upper respiratory tract infection | 156 (15·7) | 7·9 (6·7–9·3) | 79 (10·8) | 7·2 (5·7–9·0) | 89 (12·2) | 9·7 (7·8–11·9) |
| Urinary tract infection | 50 (5·0) | 2·3 (1·7–3·0) | 25 (3·4) | 2·1 (1·4–3·1) | 28 (3·8) | 2·8 (1·9–4·1) |
| Musculoskeletal and connective tissue disorders | 237 (23·8) | 12·8 (11·2–14·6) | 136 (18·6) | 13·0 (10·9–15·3) | 124 (17·0) | 14·1 (11·7–16·8) |
| Arthralgia | 67 (6·7) | 3·1 (2·4–4·0) | 37 (5·1) | 3·2 (2·2–4·4) | 30 (4·1) | 3·0 (2·1–4·3) |
| Back pain | 55 (5·5) | 2·6 (1·9–3·3) | 32 (4·4) | 2·7 (1·9–3·9) | 25 (3·4) | 2·5 (1·6–3·7) |
| Skin and subcutaneous tissue disorders | 224 (22·5) | 11·7 (10·2–13·4) | 117 (16·0) | 10·7 (8·8–12·8) | 127 (17·4) | 14·0 (11·7–16·7) |
| Psoriasisb | 61 (6·1) | 2·8 (2·1–3·6) | 35 (4·8) | 2·9 (2·0–4·1) | 35 (4·8) | 3·5 (2·4–4·9) |
| Gastrointestinal disorders | 211 (21·2) | 11·1 (9·7–12·7) | 109 (14·9) | 10·2 (8·3–12·2) | 115 (15·8) | 12·8 (10·6–15·4) |
| Injury, poisoning and procedural complications | 194 (19·5) | 10·0 (8·7–11·6) | 107 (14·6) | 9·9 (8·1–11·9) | 99 (13·6) | 10·8 (8·8–13·1) |
| Investigations | 178 (17·9) | 9·1 (7·8–10·5) | 84 (11·5) | 7·5 (6·0–9·3) | 109 (15·0) | 12·0 (9·8–14·5) |
| Nervous system disorders | 158 (15·9) | 8·1 (6·9–9·4) | 71 (9·7) | 6·4 (5·0–8·0) | 92 (12·6) | 10·0 (8·1–12·3) |
| Headache | 64 (6·4) | 3·0 (2·3–3·9) | 32 (4·4) | 2·7 (1·9–3·9) | 36 (4·9) | 3·7 (2·6–5·1) |
| General disorders and administration site conditions | 136 (13·7) | 6·8 (5·7–8·0) | 55 (7·5) | 4·8 (3·6–6·3) | 84 (11·5) | 9·1 (7·3–11·3) |
| Respiratory, thoracic and mediastinal disorders | 125 (12·6) | 6·2 (5·1–7·3) | 59 (8·1) | 5·2 (3·9–6·7) | 76 (10·4) | 8·1 (6·3–10·1) |
| Metabolism and nutrition disorders | 105 (10·6) | 5·1 (4·1–6·1) | 58 (7·9) | 5·1 (3·9–6·6) | 54 (7·4) | 5·6 (4·2–7·3) |
| Vascular disorders | 99 (9·9) | 4·8 (3·9–5·8) | 47 (6·4) | 4·1 (3·0–5·4) | 56 (7·7) | 5·9 (4·4–7·6) |
| Hypertension | 70 (7·0) | 3·3 (2·6–4·2) | 33 (4·5) | 2·9 (2·0–4·0) | 38 (5·2) | 3·9 (2·8–5·4) |
| Renal and urinary disorders | 64 (6·4) | 3·0 (2·3–3·8) | 34 (4·7) | 2·9 (2·0–4·0) | 36 (4·9) | 3·6 (2·5–5·0) |
| Eye disorders | 55 (5·5) | 2·6 (1·9–3·3) | 23 (3·1) | 1·9 (1·2–1·9) | 35 (4·8) | 3·5 (2·5–4·9) |
| Neoplasms benign, malignant and unspecified | 52 (5·2) | 2·4 (1·8–3·2) | 29 (4·0) | 2·5 (1·6–3·5) | 27 (3·7) | 2·7 (1·8–4·0) |
| Psychiatric disorders | 52 (5·2) | 2·4 (1·8–3·2) | 25 (3·4) | 2·1 (1·4–3·1) | 28 (3·8) | 2·8 (1·9–4·1) |
| Reproductive system and breast disorders | 50 (5·0) | 2·3 (1·7–3·1) | 30 (4·1) | 2·5 (1·7–3·6) | 23 (3·2) | 2·3 (1·5–3·5) |
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 of new cases; PY, patient‐years. aMedical Dictionary for Regulatory Activities (MedDRA) version 18·1. bNew or worsening psoriasis. cThe number of patients who reported at least one TEAE in the category.