Background. To investigate whether intensive treatment with methotrexate (MTX) according to a strict protocol and a computerized decision program is more beneficial compared to conventional treatment with MTX in early rheumatoid arthritis (RA).
Methods. In a 2-year multi-centre open label strategy trial, 299 patients with early RA were randomly assigned to the intensive strategy group or the conventional strategy group. Patients of both groups received MTX, the aim of treatment being remission. Patients of the intensive treatment group came to the outpatient clinic once every month; adjustment of the MTX dosage was tailored to the individual patient on the basis of predefined response criteria, using a computerized decision program. Patients of the conventional strategy group came to the outpatient clinic once every three months; they were treated according to common practice. Cylosporine was added if patients had an inadequate response to maximal tolerated MTX doses.
Results. Seventy-six (50%) patients of the intensive strategy group achieved at least one period of remission during the two year trial, versus 55 patients (37%) of the conventional strategy group (P=0.03). Areas Under the Curve for nearly all clinical variables were significantly lower, i.e. better clinical effect, for the intensive treatment group compared to the conventional treatment group.
Conclusion. The results of this study show that it is possible to enhance substantially the clinical efficacy early in the course of the disease by intensifying treatment with MTX, aiming for remission, tailored to the individual patient. Furthermore, participating rheumatologists indicated that the computerized decision program could be a helpful tool in their daily clinical practice.
- computerized decision program
- early rheumatoid arthritis
- intensive treatment
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