| Adverse event | Adalimumab exposure | ||
| Weekly (N = 72) n (%) | Any (N = 311) n (%) | Any (PY = 533.7) AE/100 PY | |
| Any AE | 62 (86.1) | 293 (94.2) | 445.6 |
| At least possibly drug-related AE | 31 (43.1) | 174 (55.9) | 107.7 |
| Serious AE | 5 (6.9) | 48 (15.4) | 10.5 |
| At least possibly drug-related serious AE | 0 | 17 (5.5) | 3.7 |
| AE leading to discontinuation of study drug | 1 (1.4) | 24 (7.7) | 4.5 |
| Infectious AE | 37 (51.4) | 213 (68.5) | 109.7 |
| Serious infectious AE | 1 (1.4) | 6 (1.9) | 1.1 |
| Appendicitis | 0 | 1 (0.3) | 0.2 |
| Bacteraemia | 0 | 1 (0.3) | 0.2 |
| Beta-haemolytic streptococcal infection | 1 (1.4) | 1 (0.3) | 0.2 |
| Cellulitis* | 0 | 1 (0.3) | 0.2 |
| Pneumonia† | 0 | 1 (0.3) | 0.2 |
| Rectal abscess† | 0 | 1 (0.3) | 0.2 |
| Drug hypersensitivity-related AE | 0 | 1 (0.3) | 0.4 |
| Malignancies | 1 (1.4) | 4 (1.3) | 0.7 |
| Basal-cell carcinoma | 0 | 1 (0.3) | 0.2 |
| Malignant melanoma | 1 (1.4) | 1 (0.3) | 0.2 |
| Non-Hodgkin’s lymphoma | 0 | 1 (0.3) | 0.2 |
| Squamous cell carcinoma of the skin | 0 | 1 (0.3) | 0.2 |
| Injection-site reactions | 2 (2.8) | 42 (13.5) | 17.6 |
| Opportunistic infections‡ | 0 | 4 (1.3) | 0.7 |
| Tuberculosis | 0 | 0 | 0 |
| Demyelinating disease | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 |
*Possibly related to adalimumab treatment. †Probably related to adalimumab treatment. ‡All four cases were oral candidiasis. AE, adverse event; PY, patient-years; TNF, tumour necrosis factor.