Table 5.
Summary of selected treatment‐emergent adverse events (TEAEs) of interest
| Total exposure, PY | All CZP (N = 995) | CZP 200 mg Q2W (N = 731) | CZP 400 mg Q2W (N = 728) |
|---|---|---|---|
| 2231·3 | 1211·4 | 1019·9 |
| n (%) | IR (95% CI) | n (%) | IR (95% CI) | n (%) | IR (95% CI) | |
|---|---|---|---|---|---|---|
| Serious infectious events | 32 (3·2) | 1·5 (1·0–2·1) | 16 (2·2) | 1·3 (0·8–2·2) | 16 (2·2) | 1·6 (0·9–2·6) |
| Opportunistic infections | 4 (0·4) | 0·2 (0·1–0·5) | 1 (0·1) | 0·1 (0·0–0·5) | 3 (0·4) | 0·3 (0·1–0·9) |
| Active tuberculosis | 1 (0·1) | 0·0 (0·0–0·3) | 0 | 0 | 1 (0·1) | 0·1 (0·0–0·6) |
| Fungal oesophagitis | 1 (0·1) | 0·0 (0·0–0·3) | 1 (0·1) | 0·1 (0·0–0·5) | 0 | 0·0 |
| Pneumonia Legionella | 1 (0·1) | 0·0 (0·0–0·3) | 0 | 0·0 | 1 (0·1) | 0·1 (0·0–0·6) |
| Bacteraemia | 1 (0·1) | 0·0 (0·0–0·3) | 0 | 0·0 | 1 (0·1) | 0·1 (0·0–0·6) |
| All malignancies | 14 (1·4) | 0·6 (0·3–1·1) | 8 (1·1) | 0·7 (0·3–1·3) | 8 (1·1) | 0·8 (0·3–1·6) |
| Malignancies excluding NMSC | 10 (1·0) | 0·5 (0·2–0·8) | 7 (1·0)a | 0·6 (0·2–1·2) | 4 (0·5)b | 0·4 (0·1–1·0) |
| NMSC | 5 (0·5) | 0·2 (0·1–0·5) | 1 (0·1)c | 0·1 (0·0–0·5) | 4 (0·5)d | 0·4 (0·1–1·0) |
| MACEs | 9 (0·9) | 0·4 (0·2–0·8) | 5 (0·7)e | 0·4 (0·1–1·0) | 4 (0·5)f | 0·4 (0·1–1·0) |
| Congestive heart failure | 1 (0·1) | 0·0 (0·0–0·3) | 0 | 0 | 1 (0·1) | 0·1 (0·0–0·6) |
| Demyelinating‐like disorders | 2 (0·2) | 0·1 (0·0–0·3) | 1 (0·1) | 0·1 (0·0–0·5) | 1 (0·1) | 0·1 (0·0–0·6) |
| Serious psoriatic conditionsg | 6 (0·6) | 0·3 (0·1–0·6) | 3 (0·4) | 0·3 (0·1–0·7) | 3 (0·4) | 0·3 (0·1–0·9) |
| Psoriasis | 3 (0·3) | 0·1 (0·0–0·4) | 2 (0·3) | 0·2 (0·0–0·6) | 1 (0·1) | 0·1 (0·0–0·6) |
| Erythrodermic psoriasis | 1 (0·1) | 0·0 (0·0–0·3) | 0 | 0 | 1 (0·1) | 0·1 (0·0–0·6) |
| Guttate psoriasis | 1 (0·1) | 0·0 (0·0–0·3) | 0 | 0 | 1 (0·1) | 0·1 (0·0–0·6) |
| Pustular psoriasis | 1 (0·1) | 0·0 (0·0–0·3) | 1 (0·1) | 0·1 (0·0–0·5) | 0 | 0 |
| Serious haematopoietic cytopenia | 1 (0·1) | 0·0 (0·0–0·3) | 1 (0·1)h | 0·1 (0·0–0·5) | 0 | 0 |
| Serious bleeding events | 11 (1·1) | 0·5 (0·3–0·9) | 7 (1·0)i | 0·6 (0·2–1·2) | 4 (0·5)j | 0·4 (0·1–1·0) |
Patients who received both certolizumab pegol (CZP) 200 mg every 2 weeks (Q2W) and CZP 400 mg Q2W are included once in the population count for the ‘all CZP’ group; n (%) refers to the number of patients who reported at least one TEAE in the category. CI, confidence interval; IR, incidence rate of new cases per 100 patient years; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer. aIncludes one each of breast cancer, glioblastoma, Hodgkin disease, laryngeal cancer, non‐small cell lung cancer, oropharyngeal squamous cell carcinoma and prostate cancer. bIncludes one each of adenocarcinoma of colon, anaplastic oligodendroglioma, prostate cancer and clear cell renal cell carcinoma. cOne basal cell carcinoma. dIncludes three basal cell carcinomas and one keratoacanthoma. eIncludes one each of acute myocardial infarction, angina pectoris and cerebrovascular accident, and two transient ischaemic attack. fIncludes one each of heart failure, congestive heart failure, acute coronary syndrome and extradural haematoma. gNew or worsening psoriasis events classified as serious. hOne abnormal blood count. iOne each of disseminated intravascular coagulation, splenic haematoma, haemorrhagic necrotic pancreatitis, rectal haemorrhage, urinary bladder haemorrhage, menorrhagia, genital haemorrhage, epistaxis and haemothorax (can be more than one per patient). jOne each of haemorrhoidal haemorrhage, upper gastrointestinal haemorrhage, haematoma infection, extradural haematoma, contusion and purpura (can be more than one per patient).