(HealthDay News) – For patients with rheumatoid arthritis with methotrexate failure, triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine is non-inferior to etanercept plus methotrexate, according to a study published online June 11 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the European League Against Rheumatism, held from June 12–15 in Madrid.
James R. O’Dell, MD, from the University of Nebraska Medical Center in Omaha, and colleagues conducted a 48-week, double-blind, non-inferiority trial in which 353 patients with rheumatoid arthritis who had active disease in spite of methotrexate therapy were randomized to a triple regimen of methotrexate, sulfasalazine, and hydroxychloroquine, or etanercept plus methotrexate. Patients without improvement at 24 weeks switched to the other therapy in a blinded fashion.
The researchers found that over the course of the first 24 weeks, both groups had significant improvement compared with baseline. In each group, 27% of participants required a switch at 24 weeks. Improvement was seen in participants in both groups who switched therapies, with no significant difference between the groups in terms of the response after switching. Between baseline and 48 weeks, the change in the Disease Activity Score for 28-joint counts was similar in the two groups; triple therapy was non-inferior to etanercept and methotrexate. There were no significant differences between the groups in secondary outcomes or major adverse events.
“With respect to clinical benefit, triple therapy, with sulfasalazine and hydroxychloroquine added to methotrexate, was non-inferior to etanercept plus methotrexate in patients with rheumatoid arthritis who had active disease despite methotrexate therapy,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.