Outcomes of Tapering Biologic and Targeted Synthetic DMARDs in Rheumatoid Arthritis: A Multicenter Randomized Non-Inferiority Trial.

Objective

Evidence supporting tapering of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in rheumatoid arthritis (RA) patients with sustained low disease activity (LDA) remains limited. We evaluated the efficacy and safety of a structured b/tsDMARD tapering strategy in patients with RA who had achieved sustained LDA.

Methods

In this 24-week, multicenter, randomized, open-label, non-inferiority trial, patients with RA receiving stable-dose b/tsDMARDs and maintaining DAS28-ESR-defined LDA for at least 6 months were randomized to either stepwise dose tapering or dose continuation. The primary endpoint was maintenance of DAS28-ESR LDA at week 24. The non-inferiority margin was prespecified as -10%. Secondary endpoints included disease activity measures, remission rates, patient-reported outcomes, quality of life, and adverse events.

Results

A total of 348 patients were randomized to the continuation group (n=177) or tapering group (n=171). In the per-protocol population, LDA was maintained in 89.6% and 88.2% of patients, respectively, with a risk difference of -1.43% (95% CI -8.09 to 5.23), meeting the prespecified criterion for non-inferiority. Similar findings were observed in the full analysis set. Most patients experiencing disease worsening regained low disease activity after protocol-guided treatment re-escalation during follow-up without permanent treatment discontinuation. Most secondary outcomes were comparable between groups, although some disease activity measures favored continuation, including DAS28-CRP at week 12 and DAS28-ESR and SDAI at week 24. Adverse events were uncommon in both groups.

Conclusion

In RA patients with sustained LDA, structured b/tsDMARD tapering was non-inferior to treatment continuation for maintaining disease control over 24 weeks.