CLINICAL AND EPIDEMIOLOGICAL RESEARCH

Increasing the infliximab dose in rheumatoid arthritis patients: a randomised, double blind study failed to confirm its efficacy

K Pavelka¹, K Jaroová¹, D Such², L enolt¹, K Chroust³, L Duek³, J Vencovsk¹

¹ Institute of Rheumatology, Department of Rheumatology of the First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic
² Rheumatology Department, Faculty Hospital Plzen, Plzen, Czech Republic
³ Institute of Biostatistics and Analyses, Masaryk Univerzity, Brno, Czech Republic

Professor K Pavelka, Institute of Rheumatology, Na Slupi 4, Prague 2, 128 50 Czech Republic; pavelka{at}revma.cz

Objective: To evaluate the effect of infliximab dose escalation in incomplete responders in a randomised controlled trial.

Methods: 141 rheumatoid arthritis (RA) patients treated with infliximab for 12 months (3 mg/kg; intervals 0, 2, 6 and then 8 weeks) who responded to the drug (disease activity score in 28 joints (DAS28) decrease >1.2) but who were not in remission (DAS28 >2.6) were enrolled into the study. Patients were randomly assigned into arm A, 3 mg/kg, and arm B, 5 mg/kg infliximab every 8 weeks. Outcome measures included the DAS28, its components and C-reactive protein (CRP).

Results: There were no significant differences in changes in the DAS28, its components, or CRP in patients in arms A and B during the 12 months of treatment. All patients showed a DAS28 decrease greater than 0.6 after 28 weeks. Eleven patients interrupted therapy in arm A and 14 in arm B. Infusion reactions and non-serious adverse events were observed in 4.2% and 28.2% of arm A patients and in 7.2% and 47.8% of arm B patients. The frequency of serious adverse events was comparable between arms A and B (16.9% and 15.9%, respectively), and the frequency of serious infections was not significantly greater in the higher dose group (5.8%) than in the lower dose group (5.6%).

Conclusions: In this setting, increasing the infliximab dose from 3 mg/kg to 5 mg/kg in RA patients with residual disease activity did not improve efficacy but moderately increased toxicity. These data indicate that a switch to another biological treatment would be a more appropriate strategy in incomplete responders.

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