title: 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).
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.
authors: Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland. marjatta.leirisalo-repo@hus.fi
authors: Marjatta
authors: M
authors: Leirisalo-Repo
authors: Hannu
authors: H
authors: Kautiainen
authors: Leena
authors: L
authors: Laasonen
authors: Markku
authors: M
authors: Korpela
authors: Markku J
authors: MJ
authors: Kauppi
authors: Oili
authors: O
authors: Kaipiainen-Seppänen
authors: Riitta
authors: R
authors: Luosujärvi
authors: Reijo
authors: R
authors: Luukkainen
authors: Anna
authors: A
authors: Karjalainen
authors: Harri
authors: H
authors: Blåfield
authors: Toini
authors: T
authors: Uutela
authors: Kirsti
authors: K
authors: Ilva
authors: Heikki A
authors: HA
authors: Julkunen
authors: Leena
authors: L
authors: Paimela
authors: Kari
authors: K
authors: Puolakka
authors: Eeva
authors: E
authors: Moilanen
authors: Pekka J
authors: PJ
authors: Hannonen
authors: Timo
authors: T
authors: Möttönen
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D061345:Early Medical Intervention; D005260:Female; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use; D060828:Induction Chemotherapy / Q000379:methods; D000069285:Infliximab; D008137:Longitudinal Studies; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D012460:Sulfasalazine / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D012460:Sulfasalazine; D006886:Hydroxychloroquine; D011239:Prednisolone; D000069285:Infliximab; D008727:Methotrexate