NEW YORK (Reuters Health) Mar 19 - Stepping down to monotherapy after 6-month combination therapy with cyclosporin A and methotrexate does not seem to be a viable option for patients with early, nonerosive rheumatoid arthritis, Italian researchers report.
Maintenance therapy with cyclosporin A alone is ineffective, the researchers found, and while step-down to methotrexate is more efficacious and better tolerated, it does not control radiographic progression.

Dr. Antonio Marchesoni, of G. Pini Orthopaedic Institute, Milan, and colleagues evaluated 57 adults who had shown signs of active rheumatoid arthritis for 6 months to 2 years without radiographic evidence of joint erosions. In an open-label protocol, all patients received cyclosporin A and methotrexate for 6 months.

Combination therapy was well tolerated, Dr. Marchesoni's team reports in the February issue of Arthritis & Rheumatism. Forty-nine of the 50 patients who completed combination therapy entered the 18-month single-agent phase of the study. According to assignments made at the beginning of the study, 22 patients continued on cyclosporin A and 27 on methotrexate.

In the cyclosporin A group, 14 of the 22 patients withdrew prematurely, including nine who withdrew because of lack of efficacy. In the methotrexate group, only four of 27 patients withdrew prematurely. "This difference was quite a remarkable one and strongly suggests that if a therapeutic approach such as the one proposed in our study is to be used, methotrexate is the drug to keep the patient on," Dr. Marchesoni told Reuters Health.

"However, methotrexate alone was not very effective in controlling radiographic progression," he added, "and this suggests that there is a need for better therapies." In the group that stepped down to methotrexate, the mean joint damage score was 5.0 at baseline and 15.0 at 24 months. The erosion scores were 0.7 and 3.0, respectively.

Dr. Marchesoni commented that "the step-down to a single-agent treatment was done after only 6 months of combination therapy, and probably this was too short a time to modify the disease course." Based on other studies he has conducted, he believes that "if methotrexate/cyclosporin A combination therapy is used as the first treatment in early rheumatoid arthritis, step-down to a single agent should not be performed before at least 1 year of therapy."

Arthritis Rheum 2002;47:59-66.

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