The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice

W. Kievit, J. Fransen, A.J.M. Oerlemans, H.H. Kuper, M.A.F.J. van de Laar, D.J.R.A.M. Rooij, C.M.A. de Gendt, K.H. Ronday, T.L. Jansen, P.C.M. van Oijen, H.L.M. Brus, Eddy M. Adang, P.L.C.M. van Riel

    Research output: Contribution to journalArticleAcademicpeer-review

    129 Citations (Scopus)

    Abstract

    Background
    Randomised controlled trials (RCTs) evaluating the efficacy of antagonists to tumour necrosis factor α (TNFα) showed high response percentages in the groups treated with active drugs.

    Objective
    To compare the efficacy of anti‐TNF treatments for rheumatoid arthritis (RA) patients in RCTs and in daily clinical practice, with an emphasis on the efficacy for patients eligible and not eligible for RCTs of anti‐TNF treatments.

    Methods
    First, randomised placebo‐controlled trials written in English for etanercept, infliximab and adalimumab for patients with RA were selected by a systematic review. Second, the DREAM (Dutch Rheumatoid Arthritis Monitoring) register with patients starting for the first time on one of the TNF‐blocking agents was used. Patient characteristics, doses of medication and co‐medication as well as the ACR20 response percentages were compared between RCTs and DREAM data, stratified for trial eligibility.

    Results
    In 10 of 11 comparisons, the ACR20 response percentages were lower in daily clinical practice than in the RCT active drug group, which was significant in five of 11 comparisons. Only 34–79% of DREAM patients fulfilled the selection criteria for disease activity in the several RCTs examined. DREAM patients eligible for RCTs had higher response percentages than ineligible DREAM patients. ACR20 response percentages of eligible DREAM patients were comparable with the ACR20 response percentages of the RCT active drug group in 10 of 11 comparisons.

    Conclusion
    The efficacy of TNF‐blocking agents in RCTs exceeded the efficacy of these drugs in clinical practice. However, in clinical practice more patients with lower disease activity were treated with TNF‐blocking agents compared with those treated in RCTs. For daily practice patients who were eligible for RCTs, responses were more similar to responses reached in RCTs.
    Original languageEnglish
    Pages (from-to)1473-1478
    JournalAnnals of the rheumatic diseases
    Volume66
    Issue number11
    DOIs
    Publication statusPublished - 2007

    Fingerprint

    Patient monitoring
    Rheumatoid Arthritis
    Randomized Controlled Trials
    Tumor Necrosis Factor-alpha
    Pharmaceutical Preparations
    Physiologic Monitoring
    Monitoring
    Patient Selection

    Keywords

    • METIS-243935

    Cite this

    Kievit, W. ; Fransen, J. ; Oerlemans, A.J.M. ; Kuper, H.H. ; van de Laar, M.A.F.J. ; Rooij, D.J.R.A.M. ; de Gendt, C.M.A. ; Ronday, K.H. ; Jansen, T.L. ; van Oijen, P.C.M. ; Brus, H.L.M. ; Adang, Eddy M. ; van Riel, P.L.C.M. / The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice. In: Annals of the rheumatic diseases. 2007 ; Vol. 66, No. 11. pp. 1473-1478.
    @article{08e9e0d9d6ce4b01a8c589b3848baa32,
    title = "The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice",
    abstract = "BackgroundRandomised controlled trials (RCTs) evaluating the efficacy of antagonists to tumour necrosis factor α (TNFα) showed high response percentages in the groups treated with active drugs.ObjectiveTo compare the efficacy of anti‐TNF treatments for rheumatoid arthritis (RA) patients in RCTs and in daily clinical practice, with an emphasis on the efficacy for patients eligible and not eligible for RCTs of anti‐TNF treatments.MethodsFirst, randomised placebo‐controlled trials written in English for etanercept, infliximab and adalimumab for patients with RA were selected by a systematic review. Second, the DREAM (Dutch Rheumatoid Arthritis Monitoring) register with patients starting for the first time on one of the TNF‐blocking agents was used. Patient characteristics, doses of medication and co‐medication as well as the ACR20 response percentages were compared between RCTs and DREAM data, stratified for trial eligibility.ResultsIn 10 of 11 comparisons, the ACR20 response percentages were lower in daily clinical practice than in the RCT active drug group, which was significant in five of 11 comparisons. Only 34–79{\%} of DREAM patients fulfilled the selection criteria for disease activity in the several RCTs examined. DREAM patients eligible for RCTs had higher response percentages than ineligible DREAM patients. ACR20 response percentages of eligible DREAM patients were comparable with the ACR20 response percentages of the RCT active drug group in 10 of 11 comparisons.ConclusionThe efficacy of TNF‐blocking agents in RCTs exceeded the efficacy of these drugs in clinical practice. However, in clinical practice more patients with lower disease activity were treated with TNF‐blocking agents compared with those treated in RCTs. For daily practice patients who were eligible for RCTs, responses were more similar to responses reached in RCTs.",
    keywords = "METIS-243935",
    author = "W. Kievit and J. Fransen and A.J.M. Oerlemans and H.H. Kuper and {van de Laar}, M.A.F.J. and D.J.R.A.M. Rooij and {de Gendt}, C.M.A. and K.H. Ronday and T.L. Jansen and {van Oijen}, P.C.M. and H.L.M. Brus and Adang, {Eddy M.} and {van Riel}, P.L.C.M.",
    year = "2007",
    doi = "10.1136/ard.2007.072447",
    language = "English",
    volume = "66",
    pages = "1473--1478",
    journal = "Annals of the rheumatic diseases",
    issn = "0003-4967",
    publisher = "BMJ Publishing Group",
    number = "11",

    }

    Kievit, W, Fransen, J, Oerlemans, AJM, Kuper, HH, van de Laar, MAFJ, Rooij, DJRAM, de Gendt, CMA, Ronday, KH, Jansen, TL, van Oijen, PCM, Brus, HLM, Adang, EM & van Riel, PLCM 2007, 'The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice' Annals of the rheumatic diseases, vol. 66, no. 11, pp. 1473-1478. https://doi.org/10.1136/ard.2007.072447

    The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice. / Kievit, W.; Fransen, J.; Oerlemans, A.J.M.; Kuper, H.H.; van de Laar, M.A.F.J.; Rooij, D.J.R.A.M.; de Gendt, C.M.A.; Ronday, K.H.; Jansen, T.L.; van Oijen, P.C.M.; Brus, H.L.M.; Adang, Eddy M.; van Riel, P.L.C.M.

    In: Annals of the rheumatic diseases, Vol. 66, No. 11, 2007, p. 1473-1478.

    Research output: Contribution to journalArticleAcademicpeer-review

    TY - JOUR

    T1 - The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice

    AU - Kievit, W.

    AU - Fransen, J.

    AU - Oerlemans, A.J.M.

    AU - Kuper, H.H.

    AU - van de Laar, M.A.F.J.

    AU - Rooij, D.J.R.A.M.

    AU - de Gendt, C.M.A.

    AU - Ronday, K.H.

    AU - Jansen, T.L.

    AU - van Oijen, P.C.M.

    AU - Brus, H.L.M.

    AU - Adang, Eddy M.

    AU - van Riel, P.L.C.M.

    PY - 2007

    Y1 - 2007

    N2 - BackgroundRandomised controlled trials (RCTs) evaluating the efficacy of antagonists to tumour necrosis factor α (TNFα) showed high response percentages in the groups treated with active drugs.ObjectiveTo compare the efficacy of anti‐TNF treatments for rheumatoid arthritis (RA) patients in RCTs and in daily clinical practice, with an emphasis on the efficacy for patients eligible and not eligible for RCTs of anti‐TNF treatments.MethodsFirst, randomised placebo‐controlled trials written in English for etanercept, infliximab and adalimumab for patients with RA were selected by a systematic review. Second, the DREAM (Dutch Rheumatoid Arthritis Monitoring) register with patients starting for the first time on one of the TNF‐blocking agents was used. Patient characteristics, doses of medication and co‐medication as well as the ACR20 response percentages were compared between RCTs and DREAM data, stratified for trial eligibility.ResultsIn 10 of 11 comparisons, the ACR20 response percentages were lower in daily clinical practice than in the RCT active drug group, which was significant in five of 11 comparisons. Only 34–79% of DREAM patients fulfilled the selection criteria for disease activity in the several RCTs examined. DREAM patients eligible for RCTs had higher response percentages than ineligible DREAM patients. ACR20 response percentages of eligible DREAM patients were comparable with the ACR20 response percentages of the RCT active drug group in 10 of 11 comparisons.ConclusionThe efficacy of TNF‐blocking agents in RCTs exceeded the efficacy of these drugs in clinical practice. However, in clinical practice more patients with lower disease activity were treated with TNF‐blocking agents compared with those treated in RCTs. For daily practice patients who were eligible for RCTs, responses were more similar to responses reached in RCTs.

    AB - BackgroundRandomised controlled trials (RCTs) evaluating the efficacy of antagonists to tumour necrosis factor α (TNFα) showed high response percentages in the groups treated with active drugs.ObjectiveTo compare the efficacy of anti‐TNF treatments for rheumatoid arthritis (RA) patients in RCTs and in daily clinical practice, with an emphasis on the efficacy for patients eligible and not eligible for RCTs of anti‐TNF treatments.MethodsFirst, randomised placebo‐controlled trials written in English for etanercept, infliximab and adalimumab for patients with RA were selected by a systematic review. Second, the DREAM (Dutch Rheumatoid Arthritis Monitoring) register with patients starting for the first time on one of the TNF‐blocking agents was used. Patient characteristics, doses of medication and co‐medication as well as the ACR20 response percentages were compared between RCTs and DREAM data, stratified for trial eligibility.ResultsIn 10 of 11 comparisons, the ACR20 response percentages were lower in daily clinical practice than in the RCT active drug group, which was significant in five of 11 comparisons. Only 34–79% of DREAM patients fulfilled the selection criteria for disease activity in the several RCTs examined. DREAM patients eligible for RCTs had higher response percentages than ineligible DREAM patients. ACR20 response percentages of eligible DREAM patients were comparable with the ACR20 response percentages of the RCT active drug group in 10 of 11 comparisons.ConclusionThe efficacy of TNF‐blocking agents in RCTs exceeded the efficacy of these drugs in clinical practice. However, in clinical practice more patients with lower disease activity were treated with TNF‐blocking agents compared with those treated in RCTs. For daily practice patients who were eligible for RCTs, responses were more similar to responses reached in RCTs.

    KW - METIS-243935

    U2 - 10.1136/ard.2007.072447

    DO - 10.1136/ard.2007.072447

    M3 - Article

    VL - 66

    SP - 1473

    EP - 1478

    JO - Annals of the rheumatic diseases

    JF - Annals of the rheumatic diseases

    SN - 0003-4967

    IS - 11

    ER -