Objectives To evaluate the efficacy and safety of infliximab for RA in daily clinical practice.
Methods We included 54 patients with refractory RA who failed at least two different DMARDs (including MTX). The patients received 3 mg/kg infliximab at weeks 0, 2, 6 and the every 8 weeks for 54 weeks. MTX and all other concomitant medications were kept at a stable during the study. Evaluations before each infusion included tender (TJC) and swollen joint counts (SJC), patient and physician global assessments, pain score (VAS), HAQ, morning stiffness, and ESR. All adverse events were recorded. We used the Wilcoxon test for two related samples to assess differences between measures taken in pairs.
Results All patients received at least 2 infusions and 9 patients completed the study through week 22, when this analysis was done. ACR components including TJC, SJC, morning stiffness, patient and physician global assessments, VAS pain, ESR and the HAQ significantly decreased at week 2 (with p < 0,001 for all these ACR components), as it is shown in Table 1. At week 6, all these ACR components showed values significantly decreased (p < 0,001) with relation to week 0 but not in comparison with week 2 (except for TJC, SJC and physician global assessment with p < 0,01). The results for clinical response and HAQ did not reach statistical significance after week 6, due to the small number of patients that completed treatment in week 14 (n = 24) and in week 22 (n = 9). One patient dropped out because of major surgery (related to the RA). The treatment was well tolerated; only minor adverse events (n = 15) without any serious infection were noted.
Conclusion Patients with refractory rheumatoid arthritis significantly improve during therapy with infliximab. The observed beneficial effect is maintained during the treatment period without major adverse events.
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