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: Marjatta Leirisalo-Repo, Hannu Kautiainen, Leena Laasonen, Markku Korpela, Markku J Kauppi, Oili Kaipiainen-Seppänen, Riitta Luosujärvi, Reijo Luukkainen, Anna Karjalainen, Harri Blåfield, Toini Uutela, Kirsti Ilva, Heikki A Julkunen, Leena Paimela, Kari Puolakka, Eeva Moilanen, Pekka J Hannonen, Timo Möttönen, NEO-RACo Study Group
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 72 Issue 6 Pg. 851-7 (Jun 2013) ISSN: 1468-2060 [Electronic] England
• PMID: 22753402 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal
• Antirheumatic Agents
• Sulfasalazine
• Hydroxychloroquine
• Prednisolone
• Infliximab
• Methotrexate

Topics

• Adult
• Anti-Inflammatory Agents (therapeutic use)
• Antibodies, Monoclonal (therapeutic use)
• Antirheumatic Agents (therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Disease Progression
• Double-Blind Method
• Drug Therapy, Combination
• Early Medical Intervention
• Female
• Humans
• Hydroxychloroquine (therapeutic use)
• Induction Chemotherapy (methods)
• Infliximab
• Longitudinal Studies
• Male
• Methotrexate (therapeutic use)
• Middle Aged
• Prednisolone (therapeutic use)
• Sulfasalazine (therapeutic use)
• Treatment Outcome