Abstract
The study was conducted on 209 patients with rheumatoid arthritis (RA) resistant to multiple disease-modifying anti-rheumatic drugs(DMARDs) including methotrexate (patients without response to these drugs, exhibiting adverse reactions requiring discontinuation of drugs, or exhibiting weaker than normal responses to drugs).There were 28 males and 181 females with a mean age of 58.9 years. Mean disease duration was 10.2 years. Tacrolimus tended to be administrated more often in advanced stage according to Steinbrocker’s classification (stage III in 106 cases and IV in 42 cases) in the present study. Of the 209 patients, 20 were treated with tacrolimus alone, while 189 received tacrolimus combined with other drugs (methotrexate in 119 cases, leflunomide in 60 cases, and other drugs in 10 cases). The initial tacrolimus dose was 0.5 mg in 11 cases, 1 mg in 181 cases, 1.5 mg in 1 case, 2 mg in 5 cases, and 3 mg in 11 cases. Responses to treatment were evaluated after 6 months of treatment, using the DAS28EULAR criteria.
Evaluation of responses after 6 months of treatment was possible in 185 (88.5%) of the 209 patients who received tacrolimus. According to the DAS28EULAR criteria, 92 cases were rated as exhibiting a good response, 64 as exhibiting a moderate response, and 29 as exhibiting no response. The response rate (the percentage of patients exhibiting moderate or better response) was 74.6% (156/209). Adverse reactions were seen in 60 (33.7%) of the 209 patients, including eruption/itching (26 cases), gastric/abdominal pain (6 cases), alopecia (4 cases), general malaise (4 cases), and others. In 15 cases, treatment had to be discontinued due to adverse reactions. These findings suggest that tacrolimus is highly effective and safe in patients with RA resistant to multiple drugs (including methotrexate), and can be expected to be very useful for drug treatment of RA.
