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. Issue 11 (1st August 2013)

• Record Type: Journal Article
• Authors: Rantalaiho, Vappu; Kautiainen, Hannu; Korpela, Markku; Hannonen, Pekka; Kaipiainen-Seppänen, Oili; Möttönen, Timo; Kauppi, Markku; Karjalainen, Anna; Laiho, Kari; Laasonen, Leena; Hakola, Mikko; Peltomaa, Ritva; Leirisalo-Repo, Marjatta
• Other Names: Alasaarela Eeva author non-byline.; Blåfield Harri author non-byline.; Eklund Kari K author non-byline.; Ilva Kirsti author non-byline.; Julkunen Heikki author non-byline.; Kononoff Aulikki author non-byline.; Krogerus Maija-Liisa author non-byline.; Luosujärvi Riitta author non-byline.; Luukkainen Reijo author non-byline.; Malmi Timo author non-byline.; Niinisalo Helena author non-byline.; Paimela Leena author non-byline.; Puolakka Kari author non-byline.; Pöllänen Jari author non-byline.; Uusitalo Tea author non-byline.; Uutela Toini author non-byline.; Valleala Heikki author non-byline.; Vuori Kaisa author non-byline.; Moilanen Eeva author non-byline.; Nieminen Riina author non-byline.; Vuolteenah Katariina author non-byline.; Leirisalo-Repo Marjatta author non-byline.; Möttönen Timo author non-byline.; Korpela Markku author non-byline.; Kauppi Markku author non-byline.; Kaipiainen-Seppänen Oili author non-byline.; Luosujärv Riitta author non-byline.
• Is Part Of: Annals of the rheumatic diseases. Volume 73:Issue 11(2014)
• Page Start: 1954
• Page End: 1961
• Publication Date: 2013-08-01
• Subjects: Early Rheumatoid Arthritis -- DMARDs (synthetic) -- DMARDs (biologic); Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2013-203497
• Languages: English
• ISSNs: 0003-4967

Abstract

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.