Original ArticleIncidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn’s disease☆
Section snippets
Patients
ACCENT I was a multicenter (55 sites), randomized, double-blinded trial of patients with moderate-to-severe Crohn’s disease (defined in part by disease of at least 3 months’ duration and a Crohn’s Disease Activity Index (CDAI)17 score between 220 and 400). Patients receiving 5-aminosalicylates, corticosteroids, or azathioprine/6-mercaptopurine (6-MP) were eligible, as described previously.16 All study procedures were carried out in accordance with ethical standards of the institutional review
Baseline characteristics and study treatment
All patients (n = 580) enrolled in ACCENT I began treatment with 5 mg/kg infliximab at week 0. At week 2, 573 patients were randomly assigned to 1 of the 3 treatment strategies, all of which included the opportunity for patients losing response at week 14 or later to cross over to episodic infliximab treatment (Figure 1). The baseline characteristics of this study population, including baseline use of immunomodulating agents, were similar across the treatment groups (Table 1). As shown in
Discussion
Monoclonal antibodies are unique proteins selected to recognize a specific biological target. All exogenous proteins, including monoclonal antibodies, are potentially immunogenic when therapeutically administered. Because of difficulties in measuring and standardizing the detection of immune responses with biologic agents, comparison of immunogenicity across products is discouraged by the United States Food and Drug Administration.19 The appropriate evaluation to determine the relative
Acknowledgements
The authors thank K.Patel for programming and statistical support and M.Perate for excellent editorial support.
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Supported by Centocor, Inc. Dr. Hanauer is a consultant and lecturer, and does clinical research, for Centocor. Dr. Mayer owns Johnson & Johnson stock. Dr. Rutgeerts received research grants and consulting fees from Centocor. All of the authors employed by Centocor, Inc., own Johnson & Johnson stock.