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Open Access Research article

Anti-infliximab antibodies are already detectable in most patients with rheumatoid arthritis halfway through an infusioncycle: an open-label pharmacokinetic cohort study

Bart JF van den Bemt1*, Alfons A den Broeder2, GJ Wolbink3, Yechiel A Hekster4, Piet LCM van Riel5, Bart Benraad1 and Frank HJ van den Hoogen2

Author Affiliations

1 Department of Pharmacy, Sint Maartenskliniek, Nijmegen, The Netherlands

2 Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands

3 Department of immunopathology, Sanquin Research, Amsterdam

4 Department of Pharmacy, Radboud University Nijmegen Medical Center Nijmegen, Nijmegen, The Netherlands

5 Department of Rheumatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

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BMC Musculoskeletal Disorders 2011, 12:12  doi:10.1186/1471-2474-12-12

Published: 13 January 2011

Abstract

Background

This study in patients with rheumatoid arthritis (RA) treated with infliximab describes prospectively the course of (anti)infliximab levels within an infusioncycle to assess at what moment patients develop low/no infliximab trough levels and/or detectable anti-infliximab levels.

Methods

Infliximab treated RA patients were included in this descriptive open-label cohort study. During one infusioncycle (anti-)infliximab levels were assessed just before and one hour after infusion, and subsequently at 50%, 75% and at the end of the infusioncycle (pre-infusion).

Results

27 patients were included. The median infliximab levels decreased from 77.0 mg/l (p25-p75: 65-89) one hour after the infusion to pre-infusion levels of 0.0 mg/l (p25-p75: 0.0-3.1). In 7 (26%) patients pre-infusion anti-infliximab antibodies were detected; these antibodies were already present halfway through the infusioncycle in 5 of the 7 individuals. Patients with detectable pre-infusion anti-infliximab antibodies have significantly more often low/no infliximab levels (< 1 mg/l) halfway trough the infusioncycle (in 5/7 patients) compared to patients without detectable pre-infusion anti-infliximab antibodies (0/20 patients, p < 0.001).

Conclusions

Most anti-infliximab forming patients have detectable anti-infliximab antibodies halfway through an infusioncycle, which implies that these patients are exposed to nontherapeutical infliximab levels during more than halve of their infusion cycle. As none of the patients without anti-infliximab antibodies had no/low-infliximab levels halfway through the infusioncycle, the presence of pre-infusion anti-infliximab antibodies seems a sensitive and specific predictor for no/low infliximab-levels