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01-12-2021 | Methotrexate | Research article

Switching from TNFα inhibitor to tacrolimus as maintenance therapy in rheumatoid arthritis after achieving low disease activity with TNFα inhibitors and methotrexate: 24-week result from a non-randomized, prospective, active-controlled trial

Authors: Sang Youn Jung, Jung Hee Koh, Ki-Jo Kim, Yong-Wook Park, Hyung-In Yang, Sung Jae Choi, Jisoo Lee, Chan-Bum Choi, Wan-Uk Kim

Published in: Arthritis Research & Therapy | Issue 1/2021

Abstract

Background

Tapering or stopping biological disease-modifying anti-rheumatic drugs has been proposed for patients with rheumatoid arthritis (RA) in remission, but it frequently results in high rates of recurrence. This study evaluates the efficacy and safety of tacrolimus (TAC) as maintenance therapy in patients with established RA in remission after receiving combination therapy with tumor necrosis factor inhibitor (TNFi) and methotrexate (MTX).

Methods

This 24-week, prospective, open-label trial included patients who received TNFi and MTX at stable doses for ≥24 weeks and had low disease activity (LDA), measured by Disease Activity Score-28 for ≥12 weeks. Patients selected one of two arms: maintenance (TNFi plus MTX) or switched (TAC plus MTX). The primary outcome was the difference in the proportion of patients maintaining LDA at week 24, which was assessed using a logistic regression model. Adverse events were monitored throughout the study period.

Results

In efficacy analysis, 80 and 34 patients were included in the maintenance and switched arms, respectively. At week 24, LDA was maintained in 99% and 91% of patients in the maintenance and switched arms, respectively (odds ratio, 0.14; 95% confidence interval, 0.01–1.59). Drug-related adverse effects tended to be more common in the switched arm than in the maintenance arm (20.9% versus 7.1%, respectively) but were well-tolerated.

Conclusion

This controlled study tested a novel treatment strategy of switching from TNFi to TAC in RA patients with sustained LDA, and the findings suggested that TNFi can be replaced with TAC in most patients without the patients experiencing flare-ups for at least 24 weeks.

Trial registration

Korea CDC CRIS, KCT0005868. Registered 4 February 2021—retrospectively registered

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Title: Switching from TNFα inhibitor to tacrolimus as maintenance therapy in rheumatoid arthritis after achieving low disease activity with TNFα inhibitors and methotrexate: 24-week result from a non-randomized, prospective, active-controlled trial
Authors: Sang Youn Jung
Jung Hee Koh
Ki-Jo Kim
Yong-Wook Park
Hyung-In Yang
Sung Jae Choi
Jisoo Lee
Chan-Bum Choi
Wan-Uk Kim
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Methotrexate
Maintenance Therapy
Methotrexate
Rheumatoid Arthritis
Tacrolimus
Published in: Arthritis Research & Therapy / Issue 1/2021
Electronic ISSN: 1478-6362
DOI: https://doi.org/10.1186/s13075-021-02566-z

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