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Clinical and epidemiological research
Extended Report
A two-step treatment strategy trial in patients with early arthritis aimed at achieving remission: the IMPROVED study
  1. L Heimans1,
  2. K V C Wevers-de Boer1,
  3. K Visser1,
  4. R J Goekoop2,
  5. M van Oosterhout3,
  6. J B Harbers4,
  7. C Bijkerk5,
  8. I Speyer6,
  9. M P D M de Buck7,
  10. P B J de Sonnaville8,
  11. B A M Grillet9,
  12. T W J Huizinga1,
  13. C F Allaart1
  1. 1Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2Department of Rheumatology, Haga Hospital, The Hague, the Netherlands
  3. 3Department of Rheumatology, Groene Hart Hospital, Gouda, The Netherlands
  4. 4Department of Rheumatology, Franciscus Hospital, Roosendaal, The Netherlands
  5. 5Department of Rheumatology, Reinier de Graaf Gasthuis, Delft, The Netherlands
  6. 6Department of Rheumatology, Bronovo Hospital, The Hague, The Netherlands
  7. 7Department of Rheumatology, Medical Center Haaglanden, The Hague, The Netherlands
  8. 8Department of Rheumatology, Admiraal de Ruyter Hospital, Goes, The Netherlands
  9. 9Department of Rheumatology, Zorgsaam, Terneuzen, The Netherlands
  1. Correspondence to L Heimans, Department of Rheumatology, Leiden University Medical Center, PO Box 9600, Leiden 2300 RC, The Netherlands; l.heimans{at}lumc.nl

Abstract

Objectives To assess which treatment strategy is most effective in inducing remission in early (rheumatoid) arthritis.

Methods 610 patients with early rheumatoid arthritis (RA 2010 criteria) or undifferentiated arthritis (UA) started treatment with methotrexate (MTX) and a tapered high dose of prednisone. Patients in early remission (Disease Activity Score <1.6 after 4 months) tapered prednisone to zero and those with persistent remission after 8 months, tapered and stopped MTX. Patients not in early remission were randomised to receive either MTX plus hydroxychloroquine plus sulfasalazine plus low-dose prednisone (arm 1) or to MTX plus adalimumab (ADA) (arm 2). If remission was present after 8 months both arms tapered to MTX monotherapy; if not, arm 1 changed to MTX plus ADA and arm 2 increased the dose of ADA. Remission rates and functional and radiological outcomes were compared between arms and between patients with RA and those with UA.

Results 375/610 (61%) patients achieved early remission. After 1 year 68% of those were in remission and 32% in drug-free remission. Of the randomised patients, 25% in arm 1 and 41% in arm 2 achieved remission at year 1 (p<0.01). Outcomes were comparable between patients with RA and those with UA.

Conclusions Initial MTX and prednisone resulted in early remission in 61% of patients with early (rheumatoid) arthritis. Of those, 68% were in remission and 32% were in drug-free remission after 1 year. In patients not in early remission, earlier introduction of ADA resulted in more remission at year 1 than first treating with disease-modifying antirheumatic drug combination therapy plus prednisone.

  • Early Rheumatoid Arthritis
  • Anti-TNF
  • DMARDs (synthetic)

https://doi.org/10.1136/annrheumdis-2013-203243

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