WASHINGTON — Treatment of early rheumatoid arthritis with an intensive methotrexate dosing strategy may provide a better overall clinical outcome than would a conventional approach with the drug, Dr. Johannes W.J. Bijlsma reported at the annual meeting of the American College of Rheumatology.
Management of early rheumatoid arthritis with intensive methotrexate treatment not only produced a higher remission rate than did conventional methotrexate treatment, but was relatively easy to administer in clinical practice, said Dr. Bijlsma of University Medical Center Utrecht (the Netherlands).
In a multicenter, randomized trial, a significantly greater percentage of 148 intensively treated patients went into clinical remission during 2 years of follow-up than did 151 conventionally-treated patients (51% vs. 39%, respectively).
Clinical remission was defined as having no swollen joints, plus meeting two of the three following criteria for at least 6 months: three or fewer tender joints; an erythrocyte sedimentation rate of 20 mm or less in the first hour; and a visual analog scale score of general well-being of 20 mm or less.
The average time to remission in the intensive treatment group was 11 months, compared with 14 months in the conventional treatment group, while the duration of remission for the two groups was 11 months and 9 months, respectively. Both findings were statistically significant; radiographic joint damage was similarly low in both groups, reported Dr. Bijlsma.
Adverse events also occurred at similar rates between the groups.
Conventional treatment consisted of one outpatient visit every 3 months in which the dose of methotrexate was increased by 5 mg/week if the number of swollen joints rose. The investigators could reduce the dose of methotrexate by 2.5 mg/week when patients went into remission.
Patients who received intensive treatment had one outpatient visit every 4 weeks. Their dosing regimen was individually tailored by a computer program that used a predefined set of criteria, noted Dr. Bijlsma.
The investigators increased the methotrexate dose if there was 20% or less improvement in the number of swollen joints, and if there was 20% or less improvement in two of the three previously mentioned criteria.
The dose decreased when the patients had no swollen joints for 3 or more months and had greater than 20% improvement in at least two of the three variables. If a patient in either group reached 30 mg/week methotrexate without a response based on the criteria, the patients then received methotrexate subcutaneously. Those who continued to show no response also received cyclosporine, reported Dr. Bijlsma.
Dosing in the intensive drug regimen was tailored by a computer program. DR. BIJLSMA
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