Adverse events between 2–5 years in patients randomised to receive initial infliximab (FIN-RACo+INFL) or initial placebo infusions (FIN-RACo+PLA) for 6 months in addition to a combination of three DMARDs and small-dose prednisolone
| Original treatment group | p Value | ||
|---|---|---|---|
| FIN-RACo+placebo (n=46) | FIN-RACo+infliximab (n=47) | ||
| Any adverse event, number (%) | 42 (91.3) | 46 (97.9) | 0.20 |
| Respiratory | 26 (56.5) | 28 (59.6) | 0.83 |
| Gastrointestinal | 20 (43.5) | 16 (34.0) | 0.40 |
| Mucocutaneous | 19 (41.3) | 17 (36.2) | 0.67 |
| Musculoskeletal | 14 (30.4) | 15 (31.9) | 0.94 |
| Urogenital | 10 (21.7) | 9 (19.1) | 0.80 |
| Central nervous system | 9 (19.6) | 8 (17.0) | 0.79 |
| Elevated liver enzymes | 10 (21.7) | 6 (12.8) | 0.28 |
| Cardiovascular | 6 (13.0) | 10 (21.3) | 0.41 |
| Psychological | 4 (8.7) | 5 (10.6) | 0.99 |
| Other | 19 (41.3) | 17 (36.2) | 0.67 |
| Serious adverse events, number (%) | 4 (8.7) | 5 (10.6) | 0.99 |
| Infections | 0 (0) | 2* (4.3) | |
| Malignancies | 0 (0) | 0 (0) | |
| Deaths | 0 (0) | 0 (0) | |
*Pneumonia, Influenza-A.