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THU0160 Excellent Outcomes Sustained Even in Long-Term When Targeted Treatment with A Combination of Traditional DMARDs Is Used in Early Rheumatoid Arthritis. The 10-Year Follow-Up Results of A Randomized Clinical Trial, The NEO-RACO Trial
  1. V. Rantalaiho1,2,
  2. T. Sandström3,
  3. J. Koski4,
  4. H. Kautiainen5,
  5. M. Leirisalo-Repo6,7
  1. 1Centre for Rheumatic Diseases, Tampere University Hospital
  2. 2School of Medicine, University of Tampere, Tampere
  3. 3Dept. of Rheumatoloy, Helsinki University Hospital, Helsinki
  4. 4Dept. of Internal Medicine, Mikkeli Central Hospita, Mikkeli
  5. 5Dept. of General Practice, University of Helsinki
  6. 6Dept. of Rheumatology, Helsinki University Hospital
  7. 7University of Helsinki, Helsinki, Finland


Background The short term outcomes of remission-targeted treatments of rheumatoid arthritis (RA) are well established, but the long-term success of such strategies is less clear, as is the role of initial add on biologics.

Objectives To assess the evolution of clinical and radiograpich outcomes over 10 years in patients with early RA treated with initial remission-targeted combination-DMARD therapy and additional infliximab or placebo infusions for the first six months

Methods Ninety-nine patients with early, DMARD-naïve RA were treated with a triple combination of DMARDs, starting with methotrexate (max 25mg/week), sulfasalazine (max 2g/day), hydroxychloroquine (35mg/kg/week), and with prednisolone (7.5mg/day), and randomized to double-blindly receive either infliximab (3mg/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 10 years the clinical and radiographic outcomes were assessed using the intention-to-treat principal.

Results Ninety patients (91%) were followed after 2 years, 43 in the FIN-RACo+INFL and 47 in the FIN-RACo+PLA group. At 10 years, the respective proportions of patients in strict ACR and in DAS28 remissions in the FIN-RACo+INFL and FIN-RACo+PLA groups were 48% and 38% [p=0.37 (NNT=10)], and 82% and 72% [p=0.30 (NNT=11)] (Figure 1). The radiographic progression remained slow in most of the patients up till 10 years, the mean (SD) total Sharp van der Hejde score (TSS) was 9.8 (14.8) in the FIN-RACo+INFL and 7.3 (8.1) in the FIN-RACo+PLA group (p=0.34). Only 15% of the patients had TSS>20, and 22% had TSS 0. By ten years, 26% of the FIN-RACo+INFL group patients and 30% of the FIN-RACo+PLA group patients were using biologics (p=0.74). After 5 years, 56% of the patients were at least sporadically using prednisolone, the mean (SD) daily dose was 1.8 (1.6) mg in the FIN-RACo+INFL group and PLA 1.6 (1.4) mg in the FIN-RACo+PLA group.

Conclusions In early RA, excellent results can be maintained up till 10 years in most patients treated with initial combination DMARDs and targeted treatment strategy. Adding initial infliximab for 6 months does not improve these outcomes.

Acknowledgement The NEO-RACo Trial Group.

Disclosure of Interest V. Rantalaiho Grant/research support from: Orion-Farmos Research Foundation, Competitive Research Funding of Tampere University Hospital, T. Sandström: None declared, J. Koski: None declared, H. Kautiainen: None declared, M. Leirisalo-Repo Grant/research support from: Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa

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