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Relapse rates in patients with rheumatoid arthritis in stable remission tapering or stopping antirheumatic therapy: interim results from the prospective randomised controlled RETRO study
  1. Judith Haschka1,2,
  2. Matthias Englbrecht1,
  3. Axel J Hueber1,
  4. Bernhard Manger1,
  5. Arnd Kleyer1,
  6. Michaela Reiser1,
  7. Stephanie Finzel1,
  8. Hans-Peter Tony3,
  9. Stefan Kleinert3,4,
  10. Martin Feuchtenberger3,5,
  11. Martin Fleck6,
  12. Karin Manger7,
  13. Wolfgang Ochs8,
  14. Matthias Schmitt-Haendle8,
  15. Joerg Wendler4,
  16. Florian Schuch4,
  17. Monika Ronneberger4,
  18. Hanns-Martin Lorenz9,10,
  19. Hubert Nuesslein11,
  20. Rieke Alten12,
  21. Winfried Demary13,
  22. Joerg Henes14,
  23. Georg Schett1,
  24. Juergen Rech1
  1. 1Department of Internal Medicine 3, University of Erlangen-Nuremberg, Erlangen, Germany
  2. 2Department of Internal Medicine 2, The Vinforce Study Group, Saint Vincent Hospital, Vienna, Austria
  3. 3Department of Internal Medicine 2, University of Wurzburg, Wurzburg, Germany
  4. 4Rheumatology Practice, Erlangen, Germany
  5. 5Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen, Germany
  6. 6Department of Rheumatology and Clinical Immunology, Asklepios Medical Center, Bad Abbach, Germany
  7. 7Rheumatology Practice, Bamberg, Germany
  8. 8Rheumatology Practice, Bayreuth, Germany
  9. 9Department of Internal Medicine V, Division of Rheumatology, University of Heidelberg, Heidelberg, Germany
  10. 10ACURA Center for Rheumatic Diseases, Baden-Baden, Germany
  11. 11Rheumatology Practice, Nuremberg, Germany
  12. 12Schlosspark Clinic, Berlin, Germany
  13. 13Rheumatology Practice, Hildesheim, Germany
  14. 14Department of Internal Medicine 2, University of Tubingen, Tubingen, Germany
  1. Correspondence to Professor Georg Schett, Department of Internal Medicine 3, Rheumatology and Immunology, University Clinic of Erlangen-Nuremberg, Ulmenweg 18, Erlangen 91054, Germany; georg.schett{at}uk-erlangen.de

Abstract

Objective To prospectively analyse the risk for disease relapses in patients with rheumatoid arthritis (RA) in sustained remission, either continuing, tapering or stopping disease-modifying antirheumatic drugs (DMARDs) in a prospective randomised controlled trial.

Methods Reduction of Therapy in patients with Rheumatoid arthritis in Ongoing remission is a multicentre, randomised controlled, parallel-group phase 3 trial evaluating the effects of tapering and stopping all conventional and/or biological DMARDs in patients with RA in stable remission. Patients (disease activity score 28 (DAS28)<2.6 for least 6 months) were randomised into three arms, either continuing DMARDs (arm 1), tapering DMARDs by 50% (arm 2) or stopping DMARDs after 6 months tapering (arm 3). The primary endpoint was sustained remission during 12 months.

Results In this interim analysis, the first 101 patients who completed the study were analysed. At baseline, all patients fulfilled DAS28 remission and 70% also American College of Rheumatology- European League Against Rheumatism Boolean remission. 82.2% of the patients received methotrexate, 40.6% biological DMARDs and 9.9% other DMARDs. Overall, 67 patients (66.3%) remained in remission for 12 months, whereas 34 patients (33.7%) relapsed. The incidence of relapses was related to study arms (p=0.007; arm 1: 15.8%; arm 2: 38.9%; arm 3: 51.9%). Multivariate logistic regression identified anticitrullinated protein antibodies (ACPA) positivity (p=0.038) and treatment reduction (in comparison to continuation) as predictors for relapse (arm 2: p=0.012; arm 3: p=0.003).

Conclusions This randomised controlled study testing three different treatment strategies in patients with RA in sustained remission demonstrated that more than half of the patients maintain in remission after tapering or stopping conventional and biological DMARD treatment. Relapses occurred particularly in the first 6 months after treatment reduction and were associated with the presence of ACPA.

Trial registration number 2009-015740-42.

  • Rheumatoid Arthritis
  • Disease Activity
  • Treatment
  • DMARDs (synthetic)
  • DMARDs (biologic)

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