Abstract
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.