An increasing number of studies has demonstrated that patients with RA in long-term remission can have safely taper their biologic therapy. An increasing number of clinical trials, observational studies, and meta-analyses has demonstrated that many patients with rheumatoid arthritis (RA) in long-term remission can safely taper their biologic therapy. 1–3
Results from a randomized double-blind sub-study of an ongoing phase 3 extension trial provide evidence that most patients in prolonged remission receiving baricitinib, a small-molecule selective Janus kinase (JAK) 1 and 2 inhibitor, may be candidates for down-titration. 4 Patients who received baricitinib 4 mg once daily for ≥15 months who had sustained low disease activity (LDA) or remission for ≥3 months were randomly assigned to either continue the same regimen or receive a reduced baricitinib dose of 2 mg once daily. Remission and LDA were defined as a clinical disease activity index (CDAI) score ≤2.8 and <10, respectively. The majority of patients (82% of participants in both groups) were treated with concomitant methotrexate (MTX).
At 48 weeks, researchers found that 67% of patients tapered to 2 mg baricitinib maintained LDA and 33% maintained remission. Of patients who continued to receive 4 mg baricitinib, 80% maintained LDA and 40% maintained remission. The rate of rescue with open-label baricitinib 4 mg and the addition or increase in dose of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) through 48 weeks was 10% in patients on baricitinib 4 mg and 18% in patients whose baricitinib dose was tapered to 2 mg.
Adverse events following random assignment into the sub-study occurred in 59.2% of patients receiving baricitinib 2 mg vs 66.7% in patients receiving baricitinib 4 mg. Dr Takeuchi and colleagues noted that while the majority of patients in both groups maintained their state of disease control (either LDA or remission) over time, tapering was associated […]
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