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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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).