SAN DIEGO — For the first time, a randomized trial has demonstrated that treatment of early undifferentiated arthritis with methotrexate can prevent progression to rheumatoid arthritis, Dr. Henrike van Dongen reported in a late-breaking poster session at the annual meeting of the American College of Rheumatology.
Findings from previous studies have suggested that early treatment of rheumatoid arthritis (RA) can lessen severity or induce remission, but until now there have been no data to show that the same benefits can occur in patients with undifferentiated, or “probable,” arthritis.
In the Early Treatment of Probable Rheumatoid Arthritis Patients with Methotrexate (PROBAAT) trial, 110 patients who did not yet fulfill ACR criteria for RA were randomized to 15 mg/week of methotrexate or placebo.
The methotrexate dose was adjusted over time based on disease severity.
At 3 months, the mean decrease in Disease Activity Severity (DAS) score was 0.39 in the methotrexate and 0.005 in the placebo group, a difference that was statistically significant.
At 18 months, fewer patients in the methotrexate group had developed RA and more had achieved remission, compared with those in the placebo group (see chart). Radiographic progression was significantly higher in the placebo group, noted Dr. van Dongen of Leiden (the Netherlands) University Medical Center.