| Group 1 | Group 2 | Group 3 | Group 4 | p Value | |
| Adverse events | |||||
| Any adverse event during 4 years | 103 (82) | 100 (83) | 106 (80) | 107 (84) | 0.87 |
| Any adverse event in years 3–4 | 76 (60) | 74 (61) | 76 (57) | 82 (64) | 0.72 |
| Infections years 3–4 | 31 (25) | 35 (29) | 24 (18) | 32 (25) | 0.23 |
| Gastrointestinal years 3–4 | 18 (14) | 13 (11) | 17 (13) | 21 (16) | 0.61 |
| Dermal/mucosal years 3–4 | 16 (13) | 16 (13) | 18 (14) | 12 (9) | 0.72 |
| Neurological years 3–4 | 9 (7) | 11 (9) | 3 (2) | 16 (13) | 0.02* |
| Cardiovascular years 3–4 | 5 (4) | 7 (6) | 13 (10) | 11 (9) | 0.25 |
| Infusion reactions years 3–4 (n) | 1 | 0 | 1 | 2 | 0.58 |
| SAE | |||||
| Any SAE during 4 years | 41 (33) | 29 (24) | 33 (25) | 26 (20) | 0.15 |
| Any SAE in years 3–4 | 26 (21) | 21 (17) | 15 (11) | 19 (15) | 0.21 |
| Total SAE during 4 years (n) | 57 | 45 | 60 | 47 | 0.31 |
| Serious infections during 4 years (n) | 12 | 2 | 5 | 6 | 0.03† |
| Malignancies during 4 years (except non-melanoma skin cancers, n) | 3 | 4 | 5 | 1 | 0.44 |
| Non-melanoma skin cancers during 4 years (n) | 2 | 0 | 1 | 3 | 0.35 |
| Deaths during 4 years (n) | 1 | 3 | 1 | 3 | 0.53 |
Values indicate the number (percentage) of patients unless indicated otherwise. *p<0.05 for group 3 versus group 4; †p<0.05 for group 1 versus group 2. Causes of death per group were the following, in group 1: pneumonia, antibiotic treatment refused (year 3); group 2: cerebrovascular accident (year 2); bronchial carcinoma and myocardial infarction (both year 4); group 3: ovarian carcinoma (year 2); group 4: disseminated tuberculosis‡24 and myocardial infarction (both year 2); septic arthritis‡ (year 3). ‡Deaths judged to be possibly related to treatment with infliximab. SAE, serious adverse event.