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| |  Adding Infliximab to Combination DMARD Treatment for Early Rheumatoid Arthritis Increases Remission Rate, Prevention of Radiological Progression: Presented at EULAR By Bruce Sylvester PARIS -- June 14, 2008 -- Adding infliximab to an effective combination disease modifying antirheumatic drug (DMARD) regimen for the treatment of early rheumatoid arthritis (RA) increases the rate of remissions and the prevention of radiological progression, researchers report. "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," said Marjatta Leirsalo-Repo, MD, Helsinki University Central Hospital, Helsinki, Finland, here on June 13 in a presentation at EULAR 2008, the Annual Congress of the European League Against Rheumatism. The authors noted, "We have previously reported that combination therapy with 3 DMARDs and prednisolone (FIN-RACo) induces 2-year remission rate of 37% in patients with early rheumatoid arthritis. [The objective was] to study whether initial combination of infliximab for 6 months to FIN-RACo strategy increases remissions and reduces joint destruction in early RA in comparison to FIN-RACo + placebo. Here we report the 2-year outcomes." Into this multicentre trial, investigators enrolled 100 patients aged <65 years with early RA (symptoms <=12 months) and active RA (>=6 swollen and >=6 tender joints, early morning stiffness >=45 minutes, and/or erythrocyte sedimentation rate (ESR) >=30 mm/hour, and/or C-reactive protein (CRP) >=20 mg/L). The researchers used FIN-RACo therapy targeted to remission as initial treatment of all subjects. They randomised subjects (double-blind) to receive infliximab (3 mg/kg) or placebo at weeks 4, 6, 10, 18, and 26. The investigators individually tailored dosing of MTX (maximum 25 mg/week) and SSZ (maximum 2 g/day). The doses of HCQ (35 mg/kg/week) and PRED (7.5 mg/day) were constant. They assessed for remission using American College of Rheumatology criteria, excluding fatigue. In cases where inefficacy/intolerability appeared, DMARDs were substituted. But these subjects were obliged to use 3 DMARDs and PRED. Local glucocorticoid injections were allowed. Mean age at entry was 46 years, median duration (interquartile range) of symptoms was 4 months, 68% were rheumatoid factor positive, and 67% were female. At baseline, the mean number of swollen joints was 15, tender joints was 20, ESR was 33 mm/hour, and Health Assessment Questionnaire (HAQ) score was 1.0. The investigators reported that, at 24 months, remission rate was 53% among FIN-RACo + placebo subjects and 70% among FIN-RACo + infliximab subjects (P = .08). However, remission rate over time was higher among FIN-RACo + infliximab subjects (odds ratio [OR] = 1.97; P = .04). Sustained remission (remission from 6 to 24 months) was achieved by 31% in the FIN-RACo + placebo group and 40% in the FIN-RACo + infliximab 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 the FIN-RACo + placebo group and 54% of subjects in the FIN-RACo + infliximab group still had a score of 0. The mean change in Sharp/van der Heijde score from 0 to 24 months was 1.4 in the FIN-RACo + placebo group and -0.2 in the FIN-RACo + infliximab 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 [infliximab] during the first 6 months reflected in higher frequencies of remissions over time and prevented radiological progression during 2 years." [Presentation title: 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. Abstract OP-0009]
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