Tapering DMARDs May Lead to Disease Flare in Patients with RA Remission: JAMA

The ARCTIC REWIND study was a multicenter, randomized, parallel, open-label noninferiority study conducted in 10 Norwegian hospital-based rheumatology practices. The researchers included a total of 160 patients with RA in remission for 12 months who were receiving stable csDMARD therapy. Researchers randomly assigned 160 patients to receive half-dose csDMARDs (n = 80) or stable-dose csDMARDs (n = 80). The major outcome assessed was the proportion of patients with a disease flare between baseline and the 12-month follow-up, defined as a combination of Disease Activity Score (DAS) greater than 1.6 (the threshold for RA remission), an increase in DAS score of 0.6 units or more, and at least 2 swollen joints. They determined the risk difference of 20% as the noninferiority margin.

Key findings of the study were:

• Among 160 patients, 155 completed the study (77 receiving half-dose and 78 receiving stable-dose csDMARDs).
• Upon evaluation, the researchers observed flares in 19 patients (25%) of the half-dose csDMARD group compared with 5 (6%) in the stable-dose csDMARD group.
• The risk difference was 18%, which failed to meet the prespecified noninferiority margin of 20 percentage points.
• They also reported adverse events in 34 patients (44%) in the half-dose group and 42 (54%) in the stable-dose group, none leading to study discontinuation.

The authors concluded, "Among patients with RA in remission taking csDMARD therapy, treatment with half-dose vs stable-dose csDMARDs did not demonstrate noninferiority for the percentage of patients with disease flares over 12 months, and there were significantly fewer flares in the stable-dose group. These findings do not support treatment with half-dose therapy."

For further information:

https://jamanetwork.com/journals/jama/article-abstract/2779548