Abstract

The purpose of this study was to evaluate the retention and discontinuation reasons of seven biological disease-modifying antirheumatic drugs (bDMARDs) in a real-world setting of patients with rheumatoid arthritis (RA). 1,037 treatment courses with bDMARDs from 2009 to 2016 [female, 81.8%; baseline age, 59.6 y; disease duration 7.8 y; rheumatoid factor positivity 81.5%; Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR), 4.4; concomitant prednisolone 43.5% and methotrexate 68.6%; Bio-naïve, 57.1%; abatacept (ABT), 21.3%; tocilizumab (TCZ), 20.7%; golimumab (GLM), 16.9%; etanercept (ETN), 13.6%; adalimumab (ADA), 11.1%; infliximab (IFX), 8.5%; certolizumab pegol (CZP), 7.9%] were included in this multi-center, retrospective study. Drug retention and discontinuation reasons at 36 months were estimated using the Kaplan-Meier method and adjusted by potent confounders using Cox proportional hazards modeling. As a result, 455 treatment courses (43.9%) were stopped, with 217 (20.9%) stopping due to inefficacy, 113 (10.9%) due to non-toxic reasons, 86 (8.3%) due to toxic adverse events, and 39 (3.8%) due to remission. Drug retention rates in the adjusted model were as follows: total retention (ABT, 60.7%; ADA, 32.7%; CZP, 43.3%; ETN, 51.9%; GLM, 45.4%; IFX, 31.1%; and TCZ, 59.2%; P < 0.001); inefficacy (ABT, 81.4%; ADA, 65.7%; CZP, 60.7%; ETN, 71.3%; GLM, 68.5%; IFX, 65.0%; and TCZ, 81.4%; P = 0.015), toxic adverse events (ABT, 89.8%; ADA, 80.5%; CZP, 83.9%; ETN, 89.2%; GLM, 85.5%; IFX, 75.6%; and TCZ, 77.2%; P = 0.50), and remission (ABT, 95.5%; ADA, 88.1%; CZP, 91.1%; ETN, 97.5%; GLM, 94.7%; IFX, 86.4%; and TCZ, 98.4%; P < 0.001). In the treatment of RA, ABT and TCZ showed higher overall retention, and TCZ showed lower inefficacy compared to IFX, while IFX showed higher discontinuation due to remission compared to ABT, ETN, GLM, and TCZ in adjusted modeling.

Highlights

  • Biological disease-modifying antirheumatic drugs have dramatically improved the management of rheumatoid arthritis (RA)

  • In the treatment of RA, ABT and TCZ showed higher overall retention, and TCZ showed lower inefficacy compared to IFX, while IFX showed higher discontinuation due to remission compared to ABT, ETN, GLM, and TCZ in adjusted modeling

  • The European League against Rheumatism (EULAR) announced a 2013 recommendation regarding the management of RA with Biological disease-modifying antirheumatic drugs (bDMARDs), in which tocilizumab (TCZ) and abatacept (ABT) were considered as efficacious and safe as Tumor necrosis factor inhibitors (TNFi), which should be considered as a first-line biologic agent [6]

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Summary

Introduction

Biological disease-modifying antirheumatic drugs (bDMARDs) have dramatically improved the management of rheumatoid arthritis (RA). The European League against Rheumatism (EULAR) announced a 2013 recommendation regarding the management of RA with bDMARDs, in which tocilizumab (TCZ) and abatacept (ABT) were considered as efficacious and safe as TNFi, which should be considered as a first-line biologic agent [6]. Drug retention in observational studies can be considered as a composite measure and index of effectiveness, safety and tolerability [4, 11,12,13]. Treatment selection and discontinuation may be influenced by factors such as differences in patient characteristics and attending physicians in observational studies, multi-center studies and the national health insurance in our country may help to diminish these possible deviations [11,12,13]

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