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Ann Rheum Dis doi:10.1136/annrheumdis-2013-203497
  • Clinical and epidemiological research
  • Extended report

Targeted treatment with a combination of traditional DMARDs produces excellent clinical and radiographic long-term outcomes in early rheumatoid arthritis regardless of initial infliximab. The 5-year follow-up results of a randomised clinical trial, the NEO-RACo trial

  1. 1Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital, Tampere, Finland
  2. 2Unit of Primary Health Care, Helsinki University Central Hospital, Helsinki, Finland
  3. 3Department of General Practice, University of Helsinki, Helsinki, Finland
  4. 4Unit of Primary Health Care, Turku University Hospital, Turku, Finland
  5. 5Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland
  6. 6Department of Medicine, Kuopio University Hospital, Kuopio, Finland
  7. 7Division of Medicine and Department of Rheumatology, Turku University Hospital, Turku, Finland
  8. 8Department of Medicine, Päijät-Häme Central Hospital, Lahti, Finland
  9. 9Department of Medicine, Oulu University Hospital, Oulu, Finland
  10. 10Helsinki Medical Imaging Centre, Helsinki University Central Hospital, Helsinki, Finland
  11. 11Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland
  12. 12Department of Clinical Medicine, University of Helsinki, Helsinki, Finland
  1. Correspondence to Dr Vappu Rantalaiho, Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital, Central Hospital, PO BOX 2000, Tampere FI-33521, Finland; vappu.rantalaiho{at}pshp.fi
  • Received 20 February 2013
  • Revised 16 June 2013
  • Accepted 9 July 2013
  • Published Online First 1 August 2013

Abstract

Objective To study whether adding initial infliximab to remission-targeted initial combination-DMARD treatment improves the long-term outcomes in patients with early rheumatoid arthritis (RA).

Methods Ninety-nine patients with early, DMARD-naïve RA were treated with a triple combination of DMARDs, starting with methotrexate (max 25 mg/week), sulfasalazine (max 2 g/day), hydroxychloroquine (35 mg/kg/week), and with prednisolone (7.5 mg/day), and randomised to double blindly receive either infliximab (3 mg/kg; FIN-RACo+INFL) or placebo (FIN-RACo+PLA) infusions during the first 6 months. After 2 years the treatment strategies became unrestricted, but the treatment goal was strict ACR remission. At 5 years the clinical and radiographic outcomes were assessed.

Results Ninety-one patients (92%) were followed up to 5 years, 45 in the FIN-RACo+INFL and 46 in the FIN-RACo+PLA groups. At 5 years, the respective proportions of patients in strict ACR and in disease activity score 28 remissions in the FIN-RACo+INFL and FIN-RACo+PLA groups were 60% (95% CI 44% to 74%) and 61% (95% CI 45% to 75%) (p=0.87), and 84% (95% CI 71% to 94%) and 89% (95% CI 76% to 96%) (p=0.51). The corresponding mean (SD) total Sharp/van der Heijde scores at 5 years were 4.3 (7.6), and 5.3 (7.3), while the respective mean Sharp/van der Heijde scores changes from baseline to 5 years were 1.6 (95% CI 0.0 to 3.4) and 3.7 (95% CI 2.2 to 5.8) (p=0.13).

Conclusions In early RA, targeted treatment with a combination of traditional DMARDs and prednisolone induces remission and minimises radiographic progression in most patients up to 5 years; adding initial infliximab for 6 months does not improve these outcomes.