Westhovens R - Escalating the infliximab dose in patients whose rheumatoid arthritis has responded only suboptimally to standard doses is safe and may improve clinical response. Methods
Study to evaluate the safety and efficacy of dose escalation of infliximib in RA pts who respond suboptimally to standard dose of 3 mg/kg/8 wks
Mostly women; median age-52y; had moderate to severe disability, with median disease duration of 7.5 yrs
They were randomized into three groups:
Group 1-placebo; group 2-infliximab, 3 mg/kg, and group 3-infliximab, 10 mg/kg, at wks 0, 2, 6, and 14
All pts got concomitant MTX ≤25 mg/wk
Primary end point: serious infections by wk 22
At that point, pts in group 1 were switched from placebo to infliximab 3 mg/kg
Pts in group 3 continued with 10 mg/kg/8 wks for the remainder of the trial
Pts in group 2 could continuing with 3 mg/kg/8 wks, or increase the dose in increments of 1.5 mg/kg at weeks 22, 30, 38, and 46 due to lack of response
Results
In group 2, 70% needed no dose escalation during the trial
20% needed one dose escalation, and small numbers had additional escalations up to 9 mg/kg
No more infections in pts who required dose escalations vs those who remained on 3 mg/kg
In contrast, in the high-dose group, the relative risk of having a serious infection by wk 22 was 3.1, vs those in the low-dose or placebo groups
See all
