Characteristics of the patients with RA included in the study and effects of dose escalation of LEF from 20 to 40 mg once daily on disease activity and the occurrence of adverse events. The response was calculated according to van Gestel 1996 et al4 after 2 months of treatment with 20 mg LEF once daily. All adverse events were mild and reversible
| Patient No | Age (years), sex | DMARDs (n) | Years since diagnosis | RF | Comedication | DAS28 with LEF20 before LEF40 | DAS28 at 2 months LEF40 | Maximum time on LEF40 (months) | Response after 2 months | Adverse events |
|---|---|---|---|---|---|---|---|---|---|---|
| DMARDs (n), number of DMARD treatments before the start of treatment with LEF; SSZ, sulfasalazine; MTX7.5, 7.5 mg methotrexate once weekly; MTX20, 20 mg methotrexate once weekly; LEF20, leflunomide 20 mg/day; LEF40, leflunomide 40 mg/day; pred, prednisone or prednisolone; DAS28, disease activity score using the 28 tender joint count, the 28 swollen joint count, and the erythrocyte sedimentation rate. | ||||||||||
| 1 | 44, F | 3 | 12 | + | Pred, MTX20 | 5.2 | 2.9 | 11 (continuing) | Good | – |
| 2 | 46, F | 2 | 3 | + | Pred, rofecoxib | 3.9 | 3.8 | 4 | No change | Glossitis |
| 3 | 67, F | – | 2 | + | Pred | 5.8 | 4.6 | 4 | Moderate | – |
| 4 | 53, F | 2 | 6 | – | Pred, MTX20 | 4.7 | 3.5 | 7 | Moderate | Abdominal pain |
| 5 | 66, F | 1 | 13 | + | Pred, | 4.8 | 3.9 | 3 (continuing) | Moderate | – |
| 6 | 34, F | 4 | 9 | + | Pred, MTX7.5, diclofenac | 4.8 | NA | 1.5 | NA | Transaminases↑ |
| 7 | 45, F | 2 | 7 | + | – | 5.7 | NA | 0.5 | NA | Nausea, diarrhoea |
| 8 | 48, M | 2 | 9 | + | Pred, SSZ | 4.4 | 4.0 | 11 | No change | – |
| 9 | 21, F | 5 | 19 | – | Pred | 4.0 | 3.3 | 2 (continuing) | Moderate | – |
| 10 | 62, F | – | 1 | + | Pred | 5.1 | 5.0 | 2 (continuing) | No change | – |
| 11 | 50, F | 2 | 11 | – | Pred | 5.2 | 3.1 | 2 (continuing) | Good | – |