Adverse events and serious adverse events during 5 years follow-up
| Sequential monotherapy | Step-up combination therapy | Initial combination with prednisone | Initial combination with infliximab | p Value | |
|---|---|---|---|---|---|
| n=126 | n=121 | n=133 | n=128 | ||
| Any adverse event during 5 years | 110 (87) | 103 (85) | 112 (84) | 112 (88) | 0.84 |
| Infections | 56 (44) | 51 (42) | 53 (40) | 61 (48) | 0.62 |
| Gastrointestinal | 56 (44) | 55 (46) | 48 (36) | 57 (45) | 0.38 |
| Dermal/mucosal | 34 (27) | 36 (30) | 39 (29) | 24 (19) | 0.16 |
| Neurological | 27 (21) | 30 (25) | 22 (17) | 25 (20) | 0.43 |
| Cardiovascular | 20 (16) | 21 (17) | 36 (27) | 26 (20) | 0.11 |
| Infusion reactions | 3 / 52 | 0 / 15 | 3 / 28 | 11 / 120 | 0.58 |
| Any SAE during 5 years | 42 (33) | 34 (28) | 37 (28) | 37 (31) | 0.76 |
| Serious infection (n) | 13 | 5 | 7 | 9 | 0.22 |
| Malignancies (n) | 5 | 4 | 6 | 4 | 0.93 |
| Death (n) | 3 | 3 | 2 | 4 | 0.68 |
Values indicate the number (percentage) of patients, unless specified otherwise. Causes of death were the following: pneumonia, pneumonia/encephalitis, non-small cell lung carcinoma (group 1); cerebrovascular accident, bronchial carcinoma, myocardial infarction (group 2); ovarian carcinoma, cerebrovascular accident (group 3); disseminated tuberculosis, myocardial infarction, septic arthritis, cerebrovascular accident (group 4).
SAE, serious adverse event.