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OP0065 Initial Infliximab is not Cost-Effective in Otherwise Actively Treated Early Rheumatoid Arthritis. the 2-Year Follow-Up Results of the Randomized Clinical Neo-Raco Trial
  1. V. Rantalaiho1,
  2. J. Martikainen2,
  3. H. Kautiainen3,
  4. K. Puolakka4,
  5. M. Leirisalo-Repo3
  6. on behalf of The NEO-RACo Study Group
  1. 1Tampere University Hospital, Tampere
  2. 2University of Kuopio, Kuopio
  3. 3Helsinki University Central Hospital, Helsinki
  4. 4South Karelia Central Hospital, Lappeenranta, Finland


Background In most early rheumatoid arthritis (RA) patients, early remission and a non-progressive state of disease can be achieved when an initial treatment with a triple combination of disease modifying antirheumatic drugs (DMARDs) and on-demand intraarticular glucocorticoids (ia GCs) is used. However, adding infliximab for the first six months to this treatment halts the otherwise marginal radiographic progression totally and decreases the number of ia GCs needed [1].

Objectives To study, with various clinical outcomes, the cost-effectiveness of adding initial infliximab to a remission-targeted combination treatment with DMARDs in early RA.

Methods During the first 2 years, the resource use of all RA-related visits, medications, and ia GCs were collected from the 99 patients with early, DMARD-naïve RA, who, within the NEO-RACo trial, were treated with the triple combination of DMARDs (methotrexate, sulphasalazine, hydroxychloriquine) and prednisolone, and who were randomized to double-blindly receive either infliximab (FIN-RACo+INFL) or placebo (FIN-RACo+PLA) infusions during the first 6 months. The treatment goal was strict remission in all patients; pre-defined treatment modifications and ia GCs were applied in active disease. The unit costs of the utilized resources were obtained from the national list of health care unit costs and other published sources. The incremental costs (ICER) for achieving an additional remission or for having radiographic non-progression at 2 years were assessed. Remission was defined by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Boolean criteria [2], as well as by the very strict FIN-RACo criteria, which allowed no tender or swollen joints [1]. Radiographic non-progression was defined as nil change in the modified Sharp van der Heijde score from baseline to 2 years.

Results The total mean costs of treatment for 2 years were €15,347 for the patients in the FIN-RACo+INFL group and €5,481 for the FIN-RACo+PLA group patients (ratio 2.80, 95% CI: 2.34 to 3.13). The Boolean ACR/EULAR remission was achieved at 2 years by 68% and 63%, the strict FIN-RACo remission by 66% and 53%, and absolute radiographic non-progression by 80% and 53% of these patients, respectively. The 2-year ICER per one additional patient achieving these outcomes by adding infliximab on the FIN-RACo strategy for the first 6 months were €208,577, €76,249, and €36,404, respectively.

Conclusions Regardless of the clinical outcome assessed, in early RA, adding a six-month course of infliximab into a targeted treatment with combination DMARDs and prednisolone cannot be considered cost-effective.


  1. Leirisalo-Repo M et al. Ann Rheum Dis 2013;72:851-7.

  2. Felson DT et al. Arthritis Rheum 2011;63:573-86.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.3265

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