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The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice
  1. W Kievit2,
  2. J Fransen2,
  3. A J M Oerlemans1,
  4. H H Kuper3,
  5. M A F J van der Laar3,
  6. D J R A M de Rooij4,
  7. C M A De Gendt5,
  8. K H Ronday6,
  9. T L Jansen7,
  10. P C M van Oijen8,
  11. H L M Brus9,
  12. E M Adang1,
  13. P L C M van Riel2
  1. 1
    Department of Medical Technology Assessment, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  2. 2
    Department of Rheumatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  3. 3
    Department of Rheumatology, Medisch Spectrum Twente, Enschede, The Netherlands
  4. 4
    Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands
  5. 5
    Department of Rheumatology, Rijnstate Hospital, Arnhem, The Netherlands
  6. 6
    Department of Rheumatology, Leyenburg Hospital, Den Haag, The Netherlands
  7. 7
    Department of Rheumatology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  8. 8
    Department of Rheumatology, Jeroen Bosch Hospital, Den Bosch, The Netherlands
  9. 9
    Department of Rheumatology, TweeSteden Hospital, Tilburg, The Netherlands
  1. W Kievit, MSc, Department of Rheumatology (470), Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands; w.kievit{at}reuma.umcn.nl

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.

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Footnotes

  • Competing interests: None.

  • Funding from the Dutch National Health Insurance Board and the Dutch affiliations of Wyeth Pharmaceuticals, Abbott Pharmaceuticals and Roche Pharmaceuticals enabled the data collection for the DREAM study.

  • Abbreviations:
    CRP
    C-reactive protein
    DMARD
    disease-modifying antirheumatic drug
    DREAM
    Dutch Rheumatoid Arthritis Monitoring
    ESR
    erythrocyte sedimentation rate
    HAS
    Health Assessment Questionnaire
    MTX
    methotrexate
    NSAID
    non-steroidal anti-inflammatory drug
    RA
    rheumatoid arthritis
    RCT
    radomised controlled trial
    TNF
    tumour necrosis virus
    VAS
    visual analogue scale

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