Table 4.
Toxicity in the three treatment arms
| Treatment arm | Arm 1 Sequential monotherapy MTX or SSZ n = 32 |
Arm 2 Combo MTX + 6 wks prednisone n = 32 |
Arm 3 Combo MTX + etanercept n = 30 |
|---|---|---|---|
| Total number of AEs | 33 | 46 | 39 |
| Number of SAEs | 2 | 1 | 0 |
| Cardiovascular | 0 | 0 | 1 |
| Pulmonary | 1 | 2 | 0 |
| Gastrointestinal | 7 | 14 | 9 |
| -Nausea | 3 | 8 | 6 |
| -Vomiting | 0 | 3 | 1 |
| -Diarrhoea | 0 | 1 | 1 |
| -Rectal Blood loss | 1 | 0 | 0 |
| -Liver enzyme abnormality | 3 | 2 | 2 |
| Neurologic | 4 | 3 | 2 |
| -Headache | 2 | 0 | 1 |
| -Sleeping disturbances | 1 | 2 | 0 |
| -Behavioral problems | 1 | 1 | 1 |
| Leukopenia | 5 | 1 | 1 |
| Skin/mucosal membranes | 3 | 4 | 3 |
| Infectious | 8 | 6 | 13 |
| -Upper respiratory tract infection | 1 | 1 | 8 |
| -Gastro-enteritis | 0 | 1 | 1 |
| -Skin/mucosal infection | 1 | 1 | 2 |
| -Fever | 2 | 1 | 1 |
| -Infectious other | 1 | 2 | 1 |
| General malaise/fatigue | 3 | 5 | 1 |
| Other | 0 | 3 | 2 |