Background Infliximab, a monoclonal antibody that binds with high affinity and specificity to TNF-alpha and neutralises its biologic activity, is approved for the reduction of the signs and symptoms of rheumatoid arthritis (RA). The Rheumatology Associates of North Alabama (RANA) is a large, community-based rheumatology practice that treats approximately 6,000 patients with RA.
Objectives To document the experience with commercial infliximab in patients with RA treated in a community rheumatology practice.
Methods In an ongoing chart review of all patients receiving infliximab at RANA, the following information was documented: age, concomitant medication use, tender and swollen joint counts, and adverse side effects.
Results Baseline information was collected for 137 patients with RA. These patients ranged in age from 33 to 84 yrs (mean of 62.7 yrs). Among the 114 patients receiving concomitant methotrexate (MTX), doses ranged from 2.5 to 30 mg/day (mean of 17.2 mg/day). At baseline (prior to the first infliximab dose), the mean dose of prednisone was 6.2 mg/day, and the mean tender and swollen joint counts were 22.4 and 13.7, respectively. Patients were treated with the currently recommended dosing regimen of 3 mg/kg at Weeks 0, 2, and 6 followed by q 8 wk dosing. Forty (29%) patients received concomitant disease-modifying antirheumatic drugs (DMARDs); 15 of these patients received concomitant leflunomide (12 with and 3 without MTX). Nine patients received infliximab without a concomitant DMARD. Data were available for 74 of these patients at Week 14 (fourth infliximab infusion). At this time point, the mean prednisone dose was 5.1 mg/day, and mean tender and swollen joint counts had improved by 65% and 69% (to 7.8 and 4.3), respectively. Improvements in steroid use and tender and swollen joint counts also were observed at Week 30 (n = 42; mean prednisone dose of 2.9 mg/day and tender/swollen joint counts of 4.4/1.7) and Week 54 (n = 14; mean prednisone dose of 2.1 mg/day and tender/swollen joint counts of 1.6/0.8) among the patients who had received treatment this long. Ten patients discontinued the use of infliximab due to lack of response (3 patients), rash (3 patients), cost (2 patients), abdominal pain (1 patient), and an unrelated side effect (neck pain in 1 patient). Five patients experienced infections (shingles, soft tissue abscess, pneumonia, and bronchitis in 2 patients); all patients responded to antibiotic therapy and continued treatment with infliximab.
Conclusion In a community rheumatology practice, infliximab 3 mg/kg, both with and without MTX, produced compelling improvement in the signs and symptoms of RA. Infliximab was safe and well tolerated when administered in the outpatient infusion setting.
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