RESEARCH - Double-blinded Remicade dose escalation in patients with RA

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Ann Rheum Dis. Published Online First: 28 March 2007.

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Extended Report

Double-blinded infliximab dose escalation in patients with rheumatoid

arthritis

Mahboob U Rahman 1, Ingrid Strusberg 2, Piet Geusens 3, Alberto Berman 4,

Yocum 5, Baker 1, Wagner 1, Han 1 and Rene

Westhovens 6*

1 Centocor Research and Development, Inc, Malvern, PA, United States

2 Centro Reumatologico Strusberg, Cordoba, Argentina

3 University Hospital Maastricht and University Hasselt, Campus Diepenbeek,

Diepenbeek, Belgium, Netherlands

4 Hospital Angel C. Padilla, Tucuman, Argentina

5 University of Arizona, Tucson, AZ, United States

6 UZ Gasthuisberg, Leuven, Belgium

Abstract

Objective: To determine the efficacy, safety, and pharmacokinetics of

infliximab dose escalation in patients with rheumatoid arthritis (RA) who

had an inadequate response to 3 mg/kg infliximab treatment or flared after

initially responding.

Methods: Patients with active RA, despite receiving methotrexate (MTX),

received infliximab 3 mg/kg at weeks 0, 2, 6, and 14 in one of the three

arms of the START trial. Beginning at week 22, patients had their infliximab

dose increased in a double-blind fashion in increments of 1.5 mg/kg if the

total tender and swollen joint count did not improve by at least 20% from

baseline (lack of response) or the improvement at week 22 or later worsened

by 50% or more (criterion for flare).

Results: Of the 329 evaluable patients, 100 (30.4%) patients required dose

escalation at or after week 22 because of flare or lack of response. The

majority of patients (> 80%) who received up to 3 dose escalations showed " d

20% improvement in the total tender and swollen joint count after their last

dose escalation. Patients who required dose escalations generally had lower

pre-infusion serum infliximab concentrations than those who did not require

dose escalations. The incidences of adverse events and serious adverse

events for the patients who received dose escalation(s) were similar to

those of patients who did not receive dose escalation.

Conclusion: Less than one third of patients required a dose escalation. The

majority of patients showed improvement after receiving increased doses of

infliximab, without an increased risk of adverse events.

http://ard.bmj.com/cgi/content/abstract/ard.2006.065995v2?papetoc

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