3-year Results of Tapering TNFi to Withdrawal Compared to Stable TNFi Among Patients with Rheumatoid Arthritis in Sustained Remission: A Multicenter Randomized Trial.

OBJECTIVES

Tapering of tumor necrosis factor inhibitor (TNFi) treatment in rheumatoid arthritis (RA) remission is debated. We assessed the effect of tapering TNFi to withdrawal versus continued stable TNFi on flare-free survival and joint damage progression over three years.

METHODS

ARCTIC REWIND was a multicenter, open-label, non-inferiority trial including patients with RA in remission for ≥12 months on stable TNFi therapy. Patients were randomized 1:1 to taper TNFi to withdrawal or continue stable treatment. The primary endpoints of the current study were flare-free survival and radiographic progression over three years. Flare-free survival was analyzed by Kaplan-Meier methods, flare rates by Cox regression, and radiographic progression by logistic mixed effects models.

RESULTS

Of 99 randomized patients, 92 received the allocated therapy, 80 completed 3-year follow-up. Mean baseline DAS based on 44 joint count was 0.8, csDMARD co-medication was used by 90%. After 3 years, 25% (95%CI: 13-38%) remained flare-free in the tapering TNFi group compared to 85% (70-93%) in the stable group, corresponding hazard ratio for flare 9.4 (3.9-22.8), p<0.0001. In the tapering group 6/41 (15%) experienced radiographic progression, compared with 3/38 (8%) in the stable group, risk difference 6.7% (-7.1%-20.5%, p=0.3). Adverse events occurred in 81% of the patients in the tapering group, and 89% of the patients in the stable group.

CONCLUSION

In contrast to those receiving stable TNFi treatment, a minority of RA patients in remission tapering TNFi to withdrawal remained flare-free over three years. There was no statistically significant difference in radiographic progression between the groups.