Abstract
ObjectiveWe evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting.MethodsSeventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks.ResultsFifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline). 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity.ConclusionsOur present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.
Highlights
Rheumatoid arthritis (RA) is a chronic, systemic disease characterized by inflammation of the synovial joints and associated with significant morbidity and mortality [1]
Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P
Multivariable logistic analysis showed that the number of biologic DMARDs previously used was independently associated with achievement of disease activity score (DAS)-low disease activity
Summary
Rheumatoid arthritis (RA) is a chronic, systemic disease characterized by inflammation of the synovial joints and associated with significant morbidity and mortality [1]. Biologic DMARDs (bDMARDs) such as tumor necrosis factor inhibitor (TNFi), tocilizumab (TCZ) and abatacept have provided dramatic changes in the management of RA, making remission an achievable goal in many patients [2]. Tofacitinib is an oral Janus kinase (JAK) inhibitor which mainly inhibits JAK1 and JAK3 and to a lesser extent, JAK2. Since these JAK families are associated with the cytoplasmic domains of various cytokine receptors such as IL-2, IL-6, IL-7, IL-12, tofacitinib can block signaling for these cytokines. Six phase 3 trials have been conducted to evaluate the efficacy and safety of tofacitinib in patients with RA who responded poorly to other bDMARDs or conventional synthetic DMARDs (csDMARDs), such as TNFi and methotrexate (MTX). We evaluated the efficacy and safety of tofacitinib in patients with RA in a real-world setting
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