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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}hus.fi

Abstract

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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Footnotes

  • Funding The study was supported by grants from the Helsinki University Central Hospital Research Funds, from Finska Läkaresällskapet and from the research funds of participating hospitals. An unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings.

  • Competing interests ML-R has received honoraria and consulting fees from Abbott, Bristol-Myers Squibb, Centocor, MSD, Pfizer, Roche and UCB. LL has received consulting fees from Abbott. MK has received honoraria and consulting fees from Abbott, BMS, GSK, MSD, Pfizer, Roche and UCB Pharma. MJK has received honoraria from Abbott, BMS, GSK, MSD Finland, Mundipharma, Pfizer, Roche and UCB. OK-S has received honoraria from Abbott, BMS, GSK, MSD Finland, Roche and UCB. AK has received honoraria from Abbott, Actelion, BMS, GSK, MSD, Pfizer, Roche, Schering-Plough and UCB. KP has received honoraria from Pfizer, MSD, Abbott, BMS, Roche and UCB. PJH has received honoraria from Abbott, AstraZeneca, BMS, GSK, MSD Finland, Mundipharma, Pfizer, Roche and UCB. HAJ has received consulting fees and travel grants from Abbott, GSK, MSD Finland, Pfizer, Roche and UCB. LP has received honoraria from Abbott, MSD Finland, Pfizer, Roche and UCB. HK, RL and EM have nothing to disclose.

  • Patient consent Obtained.

  • Ethics approval The study protocol was approved by the National Health Authorities and by the ethics committee of the Hospital District of Helsinki and Uusimaa.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Other members of the NEO-RACo Study Group Eeva Alasaarela, Kari K Eklund, Mikko Hakola, Aulikki Kononoff, Maija-Liisa Krogerus, Kari Laiho, Timo Malmi, Helena Niinisalo, Ritva Peltomaa, Jari Pöllänen, Tea Uusitalo, Heikki Valleala, and Kaisa Vuori (rheumatologists) and Riina Nieminen and Katariina Vuolteenaho (pharmacologists).

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