The addition of infliximab (INF) (Remicade®) to an effective combination DMARD (disease modifying antirheumatic drug) regimen for the treatment of early rheumatoid arthritis (RA) increases the remission rate and reverts radiological progression, researchers reported at the 2008 EULAR meeting.1
"Infliximab takes the efficacy of the FIN-RACo strategy [methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine (HCQ), and prednisolone (PRED)] to a different level and adds to its therapeutic promise in the essential work of stopping progression of disease early," Marjatta Leirsalo-Repo, MD, of Helsinki University Central Hospital in Finland, said in her presentation at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.
As background, the authors noted, "We have previously reported that combination therapy with three DMARDs and PRED (FIN-RACo) induces 2-year remission rate of 37% in patients with early RA. [The objective in this study was] to study whether initial combination of INF for 6 months to FIN-RACo strategy [MTX, SSZ, HCQ, and PRED] increases remissions and reduces joint destruction in early RA in comparison to FIN-RACo plus placebo."
The randomized, double-blind, multicenter trial enrolled 100 patients aged <65 years with early RA (symptoms <12 mo) and active (>6 swollen joints and >6 tender joints, early morning stiffness >45 min, and/or erythrocyte sedimentation rate (ESR) >30 mm/hour, and/or C-reactive protein >20 mg/L).
The researchers used FIN-RACo therapy targeted to remission as initial treatment of all subjects, who received INF (3 mg/kg) or placebo at weeks 4, 6, 10, 18, and 26. Dosing of MTX was individually tailored (maximum 25 mg/week) and SSZ (maximum 2 g/day); doses of HCQ (35 mg/kg/week) and PRED (7.5 mg/day) were constant. Remission was assessed using American College of Rheumatology criteria, excluding fatigue.
At baseline, the mean number (SD) of swollen joints was 15, tender joints 20, ESR 33 mm/hour, and Health Assessment Questionnaire 1. At 24 months, the remission rate was 53% among FIN-RACo plus placebo subjects and 70% among FIN-RACo plus INF subjects (P = .08). However, remission rate over time was higher among FIN-RACo plus INF subjects (OR =1.97, P = .04). Sustained remission (6-24 months) was achieved by 31% in the FIN-RACo plus placebo group and 40% in the FIN-RACo plus INF group (P = .40).
At baseline, the median total Sharp/van der Heijde score was 0 in both groups. At 24 months, 41% of the subjects in FIN-RACo plus placebo and 54% in FIN-RACo plus INF still had a score of 0. The mean change of Sharp/van der Heijde score from 0 to 24 months was 1.4 in the FIN-RACo plus placebo group and -0.2 in FIN-RACo plus INF group (P = .005).
The authors concluded, "Intensive use of FIN-RACo strategy in early active RA induced strict remission in 53% and sustained remission in 31% of patients. Radiological progression was rare. Adding INF during the first 6 months reflected in higher frequencies of remissions over time and prevented radiological progression during 2 years."
Reference
1. Leirisalo-Repo M, Kautiainen H, Laasonen L, et al. A randomized, double-blind, placebo-controlled study on addition of infliximab to the FIN-RACO DMARD combination therapy for initial six months in patients with early active rheumatoid arthritis. The NEO-RACO study. Presented at: EULAR 2008; June 11-14, 2008; Paris, France. Presentation OP-0009.
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