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Infliximab for 6 months added on combination therapy in early rheumatoid arthritis: 2-year results from an investigator-initiated, randomised, double-blind, placebo-controlled study (the NEO-RACo Study)
  1. Marjatta Leirisalo-Repo1,2,
  2. Hannu Kautiainen3,4,
  3. Leena Laasonen5,
  4. Markku Korpela6,
  5. Markku J Kauppi7,8,
  6. Oili Kaipiainen-Seppänen9,
  7. Riitta Luosujärvi1,9,
  8. Reijo Luukkainen10,
  9. Anna Karjalainen11,
  10. Harri Blåfield12,
  11. Toini Uutela13,
  12. Kirsti Ilva14,
  13. Heikki A Julkunen15,
  14. Leena Paimela3,
  15. Kari Puolakka16,
  16. Eeva Moilanen17,
  17. Pekka J Hannonen18,
  18. Timo Möttönen19,20,
  19. for the NEO-RACo Study Group
  1. 1Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland
  2. 2Department of Clinical Medicine, University of Helsinki, Helsinki, Finland
  3. 3Rehabilitation Unit, Orton Hospital, Helsinki, Finland
  4. 4Unit of Family Practice, Jyväskylä Central Hospital, Jyväskylä, Finland
  5. 5Helsinki Medical Imaging Centre, Helsinki University Central Hospital, Helsinki, Finland
  6. 6Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital, Tampere, Finland
  7. 7Rheumatism Foundation Hospital, Heinola, Finland
  8. 8Department of Medicine, Päijät-Häme Central Hospital, Lahti, Finland
  9. 9Department of Medicine, Kuopio University Hospital, Kuopio, Finland
  10. 10Department of Rheumatology, Satakunta Central Hospital, Rauma, Finland
  11. 11Department of Medicine, Oulu University Hospital, Oulu, Finland
  12. 12Department of Medicine, Seinäjoki Central Hospital, Seinäjoki, Finland
  13. 13Department of Medicine, Central Hospital of Lapland, Rovaniemi, Finland
  14. 14Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna, Finland
  15. 15Department of Medicine, Helsinki University Central Hospital, Peijas Hospital, Vantaa, Finland
  16. 16Department of Medicine, Lappeenranta Central Hospital, Lappeenranta, Finland
  17. 17The Immunopharmacology Research Group, University of Tampere Medical School and Tampere University Hospital, Tampere, Finland
  18. 18Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland
  19. 19Department of Rheumatology, Turku University Hospital, Turku, Finland
  20. 20Department of Medicine, University of Turku, Turku, Finland
  1. Correspondence to
    Professor Marjatta Leirisalo-Repo, Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, P O Box 440, Helsinki FI-00029 HUS, Finland; marjatta.leirisalo-repo{at}


Objective Early treatment of patients with rheumatoid arthritis (RA) with combination treatment starting with methotrexate, sulfasalazine, hydroxychloroquine and prednisolone (FIN-RACo strategy) is superior to monotherapy. A study was undertaken to determine whether infliximab (INFL) added to intensified FIN-RACo treatment for the initial 6 months improves the 2-year outcome.

Methods 99 patients with early untreated active RA were enrolled in an investigator-initiated, randomised, double-blind, multicentre, parallel-group trial. Primary outcomes were remission and radiological changes at 2 years. All patients started with FIN-RACo. In addition, they were randomised to receive INFL or placebo (Pla) from weeks 4 to 26.

Results At 24 months, 66% and 53%, respectively, of the patients in the FIN-RACo+INFL and FIN-RACo+Pla groups were in remission according to the modified American College of Rheumatology (ACR) criteria (p=0.19), 26% and 10% were in sustained modified ACR remission (p=0.042) and 82% in both groups were in remission by 28-joint disease activity score (not significant). Mean changes in the total Sharp-van der Heijde score were 0.2 and 1.4, respectively (p=0.0058).

Conclusions Most patients with early active RA achieve clinical remission and develop negligible joint damage with the intensified FIN-RACo regimen. Adding INFL for the first 6 months delays radiological progression.

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