Rheumatoid Arthritis: Remission Sustainable With Tapering of Biologics

Professor Paul Emery Arthritis Research UK Professor of Rheumatology Director - Leeds Musculoskeletal Biomedical Research Unit, LTHT Director – Leeds Institute of Rheumatic and Musculoskeletal Medicine University of LeedsMedicalResearch.com Interview
Professor Paul Emery
Arthritis Research UK Professor of Rheumatology
Director – Leeds Musculoskeletal Biomedical Research Unit, LTHT Director – Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds

Medical Research: What is the background for this study? What are the main findings?

Professor Emery: Joint damage and functional disability are common in people who suffer from rheumatoid arthritis (RA), even in those with early disease. We know that early aggressive treatment with biologics, such as the anti-TNF agent etanercept, results in rapid remission in many patients with moderate-to-severe rheumatoid arthritis, which can help reduce the risk of joint destruction and disability long term. However, we don’t yet know whether remission achieved with biologic therapy can be maintained after doses are reduced or therapy is withdrawn.

The PRIZE trial, a “state-of-the-art” biologic treatment trial conducted in adults with early untreated rheumatoid arthritis, was designed to fill this knowledge gap. The trial included three phases:

  • 1) induction therapy with full-dose combination etanercept-methotrexate therapy;
  • 2) maintenance therapy with a reduced-dose etanercept-methotrexate regimen, methotrexate alone, or no treatment; and
  • 3) complete treatment withdrawal. After clinical remission was induced, remission was shown to be effectively maintained with the reduced-dose combination regimen but not with the biologic-free regimens.Significantly more patients who had received the reduced-dose regimen were in remission after therapy was withdrawn than patients who received no therapy after remission induction. Interestingly, however, after remission was induced with the full-dose combination regimen, no substantial progression of joint damage on x-ray was seen in patients receiving the reduced-dose regimen, methotrexate only, or no treatment.

Medical Research: What should clinicians and patients take away from your report?

Professor Emery: Results of the PRIZE trial suggest that some patients who achieve remission with early, aggressive biologic treatment may be candidates for subsequent treatment reduction or withdrawal. This is good news for clinicians and patients who may prefer reduced-dose, step-down, or treatment-free options after remission induction with biologics because of safety or cost concerns. However, if such an approach is chosen, clinicians need to closely monitor their patients for signs of worsening disease activity or function, or radiographic progression, which would signal the need for re-assessment and possible retreatment.

Medical Research: What recommendations do you have for future research as a result of this study?

Professor Emery: Additional research is needed to establish ideal remission induction and maintenance treatment regimens in patients with rheumatoid arthritis and to identify factors that predict the successful reduction or discontinuation of therapy after remission is achieved. Detection of th latter predictors, such as baseline patient characteristics or response thresholds, would allow clinicians to take a more personalized approach to the management of patients with RA.

Citation:

Sustained Remission with Etanercept Tapering in Early Rheumatoid Arthritis

Paul Emery, F.R.C.P., Mohammed Hammoudeh, M.D., Oliver FitzGerald, M.D., Bernard Combe, M.D., Ph.D., Emilio Martin-Mola, M.D., Ph.D., Maya H. Buch, M.B., Ch.B., Ph.D., Marek Krogulec, M.D., Theresa Williams, P.A., M.S., Stefanie Gaylord, B.S.N., Ronald Pedersen, M.S., Jack Bukowski, M.D., Ph.D., and Bonnie Vlahos, M.B.A., R.N.

N Engl J Med 2014; 371:1781-1792
November 6, 2014

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