Abstract

This multi-center, retrospective study aimed to clarify the factors affecting drug retention of the Janus kinase inhibitors (JAKi) including baricitinib (BAR) and tofacitinib (TOF) in patients with RA. Patients were as follows; females, 80.6%; age, 60.5 years; DAS28-ESR, 4.3; treated with either BAR (n = 166) or TOF (n = 185); bDMARDs- or JAKi-switched cases (76.6%). The reasons for drug discontinuation were classified into four major categories. The drug retention was evaluated at 24 months using the Kaplan–Meier method and multivariate Cox proportional hazards modelling adjusted by confounders. Discontinuation rates for the corresponding reasons were as follows; ineffectiveness (22.3%), toxic adverse events (13.3%), non-toxic reasons (7.2%) and remission (0.0%). Prior history of anti-interleukin-6 receptor antibody (aIL-6R) ineffectiveness significantly increased the risk of treatment discontinuation due to ineffectiveness (p = 0.020). Aging (≥ 75 years) (p = 0.028), usage of PSL ≥ 5 mg/day (p = 0.017) and female sex (p = 0.041) significantly increased the risk of treatment discontinuation due to toxic adverse events. Factors not associated with treatment discontinuation were: number of prior bDMARDs or JAKi, concomitant MTX usage, difference of JAKi, and prior use of TNF inhibitor, CTLA4-Ig or other JAKi.

Highlights

  • This multi-center, retrospective study aimed to clarify the factors affecting drug retention of the Janus kinase inhibitors (JAKi) including baricitinib (BAR) and tofacitinib (TOF) in patients with rheumatoid arthritis (RA)

  • We have recently reported the drug retention rates of ­bDMARDs7–12, factors affecting the efficacy of ­bDMARDs13,14 and factors affecting the achievement of biological disease-modifying antirheumatic drugs (bDMARDs)-free r­ emission[15] on the basis of findings from our cohort

  • Patients were treated by a low dose and ratio of MTX, and had mostly switched from other bDMARDs or JAKi, suggesting ‘difficult-to-treat’ backgrounds

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Summary

Introduction

This multi-center, retrospective study aimed to clarify the factors affecting drug retention of the Janus kinase inhibitors (JAKi) including baricitinib (BAR) and tofacitinib (TOF) in patients with RA. Factors not associated with treatment discontinuation were: number of prior bDMARDs or JAKi, concomitant MTX usage, difference of JAKi, and prior use of TNF inhibitor, CTLA4-Ig or other JAKi. The recommendations of the 2019 European League Against Rheumatism (EULAR) stated that the efficacies of anti-interleukin (IL)-6 receptor antibody (aIL-6R; tocilizumab and sarilumab), cytotoxic T lymphocyte-associated antigen-4-Ig (CTLA4-Ig; abatacept) and Janus kinase inhibitors (JAKi) such as baricitinib (BAR; a JAK1 and JAK2 inhibitor) and tofacitinib (TOF; a JAK1 and JAK3 inhibitor) are considered equivalent to those of tumor necrosis factor inhibitors (TNFi) in both Phase II and Phase III treatments of rheumatoid arthritis (RA)[1]. The aim of the present multicenter, retrospective study is to clarify the factors affecting drug retention of a JAKi (BAR or TOF) in real-world settings

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