RESEARCH - Increasing the Remicade dose in RA patients: a randomized, double blind study failed to confirm its efficacy

[Guest guest]

Ann Rheum Dis. Published Online First: 6 April 2009.

doi:10.1136/ard.2008.090860

--------------------------------------------------------------------------------

Extended Report

Increasing the infliximab dose in rheumatoid arthritis patients: a

randomized, double blind study failed to confirm its efficacy

K Pavelka 1*, K Jaroová 1, D Such 2, L enolt 1, K Chroust 3, L Duek 3

and J Vencovsk 1

1 Institute of Rheumatology, Prague, Czech Republic

2 Department of Clinical Pharmacology, Pilsen, Czech Republic

3 Centre for Biostatistics and Analyses, Masaryk University, Brno,

Czech Republic

Abstract

Objective: To evaluate the effect of infliximab dose escalation in

incomplete responders in a randomized controlled trial.

Methods: We enrolled 141 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 (DAS28) decrease >1.2)] but who

were not in remission (DAS28>2.6). Patients were randomized into arm

A, 3 mg/kg, and arm B, 5 mg/kg infliximab every 8 weeks. Outcome

measures included DAS28, its components, and C-reactive protein (CRP).

Results: There were no significant differences in changes in DAS28,

its components, or CRP in patients in arms A and B during the 12

months of treatment. All patients showed a DAS28 decrease >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 higher 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 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.

http://ard.bmj.com/cgi/content/abstract/ard.2008.090860v1?papetoc

Not an MD