Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study

Elise van Mulligen (Corresponding author), Pascal Hendrik Pieter de Jong, Tjallingius Martijn Kuijper, Myrthe van der Ven, Cathelijne Appels, Casper Bijkerk, Joop B. Harbers, Yael de Man, T.H. Esmeralda Molenaar, Ilja Tchetverikov, Yvonne P.M. Goekoop-Ruiterman, Jende van Zeben, Johanna M.W. Hazes, Angelique E.A.M. Weel, Jolanda J. Luime

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Objectives: The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up. Methods: In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time. Results: A total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. Conclusion Up to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.

TaalEngels
Pagina's746-753
Aantal pagina's8
TijdschriftAnnals of the Rheumatic Diseases
Volume78
Nummer van het tijdschrift6
DOI's
StatusGepubliceerd - 1 jun 2019

Vingerafdruk

Antirheumatic Agents
Rheumatoid Arthritis
Joints
Health
Cost reduction
Randomized Controlled Trials
Nurses
Quality of Life
Costs and Cost Analysis
Research

Trefwoorden

    Citeer dit

    van Mulligen, Elise ; de Jong, Pascal Hendrik Pieter ; Kuijper, Tjallingius Martijn ; van der Ven, Myrthe ; Appels, Cathelijne ; Bijkerk, Casper ; Harbers, Joop B. ; de Man, Yael ; Molenaar, T.H. Esmeralda ; Tchetverikov, Ilja ; Goekoop-Ruiterman, Yvonne P.M. ; van Zeben, Jende ; Hazes, Johanna M.W. ; Weel, Angelique E.A.M. ; Luime, Jolanda J./ Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis : first-year results of the randomised controlled TARA study. In: Annals of the Rheumatic Diseases. 2019 ; Vol. 78, Nr. 6. blz. 746-753
    @article{ea8d76ee003c4a2f9d78f8ddbabf36cc,
    title = "Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study",
    abstract = "Objectives: The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up. Methods: In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time. Results: A total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 {\%} (95{\%} CI,24{\%} to 43 {\%}) and 43 {\%} (95{\%} CI, 33{\%} to 53 {\%} (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. Conclusion Up to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 {\%} favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.",
    keywords = "anti-TNF therapy, csdmards, drug withdrawal, rheumatoid arthritis, tapering",
    author = "{van Mulligen}, Elise and {de Jong}, {Pascal Hendrik Pieter} and Kuijper, {Tjallingius Martijn} and {van der Ven}, Myrthe and Cathelijne Appels and Casper Bijkerk and Harbers, {Joop B.} and {de Man}, Yael and Molenaar, {T.H. Esmeralda} and Ilja Tchetverikov and Goekoop-Ruiterman, {Yvonne P.M.} and {van Zeben}, Jende and Hazes, {Johanna M.W.} and Weel, {Angelique E.A.M.} and Luime, {Jolanda J.}",
    year = "2019",
    month = "6",
    day = "1",
    doi = "10.1136/annrheumdis-2018-214970",
    language = "English",
    volume = "78",
    pages = "746--753",
    journal = "Annals of the Rheumatic Diseases",
    issn = "0003-4967",
    publisher = "BMJ Publishing Group",
    number = "6",

    }

    van Mulligen, E, de Jong, PHP, Kuijper, TM, van der Ven, M, Appels, C, Bijkerk, C, Harbers, JB, de Man, Y, Molenaar, THE, Tchetverikov, I, Goekoop-Ruiterman, YPM, van Zeben, J, Hazes, JMW, Weel, AEAM & Luime, JJ 2019, 'Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study' Annals of the Rheumatic Diseases, vol. 78, nr. 6, blz. 746-753. DOI: 10.1136/annrheumdis-2018-214970

    Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis : first-year results of the randomised controlled TARA study. / van Mulligen, Elise (Corresponding author); de Jong, Pascal Hendrik Pieter; Kuijper, Tjallingius Martijn; van der Ven, Myrthe; Appels, Cathelijne; Bijkerk, Casper; Harbers, Joop B.; de Man, Yael; Molenaar, T.H. Esmeralda; Tchetverikov, Ilja; Goekoop-Ruiterman, Yvonne P.M.; van Zeben, Jende; Hazes, Johanna M.W.; Weel, Angelique E.A.M.; Luime, Jolanda J.

    In: Annals of the Rheumatic Diseases, Vol. 78, Nr. 6, 01.06.2019, blz. 746-753.

    Onderzoeksoutput: Bijdrage aan tijdschriftTijdschriftartikelAcademicpeer review

    TY - JOUR

    T1 - Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis

    T2 - Annals of the Rheumatic Diseases

    AU - van Mulligen,Elise

    AU - de Jong,Pascal Hendrik Pieter

    AU - Kuijper,Tjallingius Martijn

    AU - van der Ven,Myrthe

    AU - Appels,Cathelijne

    AU - Bijkerk,Casper

    AU - Harbers,Joop B.

    AU - de Man,Yael

    AU - Molenaar,T.H. Esmeralda

    AU - Tchetverikov,Ilja

    AU - Goekoop-Ruiterman,Yvonne P.M.

    AU - van Zeben,Jende

    AU - Hazes,Johanna M.W.

    AU - Weel,Angelique E.A.M.

    AU - Luime,Jolanda J.

    PY - 2019/6/1

    Y1 - 2019/6/1

    N2 - Objectives: The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up. Methods: In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time. Results: A total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. Conclusion Up to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.

    AB - Objectives: The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up. Methods: In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time. Results: A total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. Conclusion Up to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.

    KW - anti-TNF therapy

    KW - csdmards

    KW - drug withdrawal

    KW - rheumatoid arthritis

    KW - tapering

    UR - http://www.scopus.com/inward/record.url?scp=85064003323&partnerID=8YFLogxK

    U2 - 10.1136/annrheumdis-2018-214970

    DO - 10.1136/annrheumdis-2018-214970

    M3 - Article

    VL - 78

    SP - 746

    EP - 753

    JO - Annals of the Rheumatic Diseases

    JF - Annals of the Rheumatic Diseases

    SN - 0003-4967

    IS - 6

    ER -