Leflunomide (LFL) is a modern immunomodulating medication belonging to the group of drugs that favourably affect the course of rheumatoid arthritis (RA). We present in this study the results of an open prospective trial on the effectiveness and side effects of LFL in clinically followed up patients with active RA refractory to other disease modifying anti-rheumatic drugs (DMARDS). At the onset of treatment with LFL the patients had at least 8 swollen and tender joints, the disease severity being assessed by both patients and physicians as over 3 cm VAS. ESR was higher than 40mm/lh. In all patients previous treatment with disease modifying drugs received for at least 3 months was insufficiently effective. It was discontinued prior to the therapy with LFL. Assessment of the therapeutic results was made at 3, 6 and 12 months after onset of LFL therapy. The following parameters were followed-up: 1) Number of tender joints, 2) Number of swollen joints, 3) Morning stiffness (min), 4) Global assessment of the patient (VAS 1-10 cm), 5) Global assessment of the physician (VAS 1-10 cm); 6) ESR - mm/lh; 7) Mean HAQ - the sum of all scores (0-3), divided by the number of the questions5; 8) SDAI index of RA activity6; 9) ACR20% and ACR50% positive therapeutic effect2.
Results: 82 patients (mean age 53.9 yrs, age range 20-70, 12 males, 70 females) were studied. RA was diagnosed in 80 (97.6%); RA combined with spondyloarthritis was diagnosed in 2 patients (2.4%). The mean duration of RA was 5.1 +/- 3.4 yrs. 70 patients (85.4%) were rheumatoid factor positive. The therapeutic effect from the administration of LFL was markedly good as early as at 3 months from beginning of treatment and was sustained significantly favourable at 12 months. The therapeutic effect of LFL referring to ACR20% is high - 36% at 3 months from onset of therapy and increased to 51% at 12 months. A grave side effect - leucopenia with granulocytopenia was observed in one female patient. LFL is a novel effective disease-modifying drug used to treat refractory RA. In a short term period - 3 to 6 months, LFL leads to a significant clinical and functional improvement of the patients.