title: 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.
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.
authors.affiliation: Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital, Tampere, Finland.
authors.forename: Vappu
authors.initials: V
authors.lastname: Rantalaiho
authors.affiliation: Unit of Primary Health Care, Helsinki University Central Hospital, Helsinki, Finland Department of General Practice, University of Helsinki, Helsinki, Finland Unit of Primary Health Care, Turku University Hospital, Turku, Finland.
authors.forename: Hannu
authors.initials: H
authors.lastname: Kautiainen
authors.affiliation: Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital, Tampere, Finland.
authors.forename: Markku
authors.initials: M
authors.lastname: Korpela
authors.affiliation: Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
authors.forename: Pekka
authors.initials: P
authors.lastname: Hannonen
authors.affiliation: Department of Medicine, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Oili
authors.initials: O
authors.lastname: Kaipiainen-Seppänen
authors.affiliation: Division of Medicine and Department of Rheumatology, Turku University Hospital, Turku, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Möttönen
authors.affiliation: Department of Medicine, Päijät-Häme Central Hospital, Lahti, Finland.
authors.forename: Markku
authors.initials: M
authors.lastname: Kauppi
authors.affiliation: Department of Medicine, Oulu University Hospital, Oulu, Finland.
authors.forename: Anna
authors.initials: A
authors.lastname: Karjalainen
authors.affiliation: Department of Medicine, Päijät-Häme Central Hospital, Lahti, Finland.
authors.forename: Kari
authors.initials: K
authors.lastname: Laiho
authors.affiliation: Helsinki Medical Imaging Centre, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Leena
authors.initials: L
authors.lastname: Laasonen
authors.affiliation: Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
authors.forename: Mikko
authors.initials: M
authors.lastname: Hakola
authors.affiliation: Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Ritva
authors.initials: R
authors.lastname: Peltomaa
authors.affiliation: Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland Department of Clinical Medicine, University of Helsinki, Helsinki, Finland.
authors.forename: Marjatta
authors.initials: M
authors.lastname: Leirisalo-Repo
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D011859:Radiography; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D011239:Prednisolone; D000069285:Infliximab
keywords: DMARDs (biologic); DMARDs (synthetic); Early Rheumatoid Arthritis