PARIS — The addition of infliximab to intensive combination disease-modifying therapy in early rheumatoid arthritis resulted in higher rates of remission and no radiographic progression at 2 years in a placebo-controlled trial of 100 patients.
Combination therapy with methotrexate, sulfasalazine, and hydroxychloroquine plus prednisone has previously been shown to be associated with a remission rate of 37% in patients with early RA, Dr. Marjatta Leirisalo-Repo said at the annual European Congress of Rheumatology.
In the current trial of 100 patients with RA of less than 1 year's duration, the patients were randomized to the regimen in the Finnish Rheumatoid Arthritis Combination Therapy (FIN-RACo) trial plus infliximab or placebo, to determine whether the addition of the tumor necrosis factor (TNF) blocking agent would increase rates of remission and influence radiographic outcome.
The intensive, remission-targeted FIN-RACo regimen includes individually tailored doses of methotrexate, up to 25 mg/wk, and sulfasalazine, at a maximum of 2 g/day, along with fixed doses of hydroxychloroquine (35 mg/kg per week) and prednisone (7.5 mg/day).
In addition to the combination disease-modifying antirheumatic drug (DMARD) regimen, patients received placebo or infliximab in doses of 3 mg/kg at weeks 4, 6, 10, 18, and 26, and were followed for 2 years.
At baseline, patients had active disease, said Dr. Leirisalo-Repo of the division of rheumatology at Helsinki University Central Hospital. The patients' mean age was 46 years, and the median duration of their symptoms was 4 months; 68% of the patients were rheumatoid factor positive, and 67% were female. The mean number of swollen joints was 15, the mean number of tender joints was 20, the mean erythrocyte sedimentation rate was 33 mm/hr, and the mean Health Assessment Questionnaire (HAQ) score was 1.
At 24 months, the remission rate was 53% among patients receiving the combination plus placebo regimen and 70% in the combination plus infliximab group. Sustained remission out to 24 months was seen in 31% and 40% of those in the placebo and infliximab groups, respectively.
“Patients in the infliximab group had an overall odds ratio of 2.24 for reaching remission,” Dr. Leirisalo-Repo said.
The median total Sharp/van der Heijde score was 0 at baseline in both groups. At 2 years, the score was 1.4 in the placebo group compared with 0.2 in the infliximab group, suggesting that there had been almost no radiographic progression in the infliximab group, she said.
In conclusion, the intensive FIN-RICo combination strategy resulted in remission rates of 53% and sustained remission rates of 31%, but the addition of infliximab for 6 months further increased these rates and prevented radiographic damage, she said.
Dr. Leirisalo-Repo disclosed that she has received research grants from Schering-Plough Finland and consulting fees from Centocor Inc., and that she holds nonremunerative positions of influence with Abbott Laboratories, Bristol-Myers Squibb Co., and Roche.