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Gastroenterology
Volume 134, Issue 7
, Pages
1861-1868
, June 2008
Withdrawal of Immunosuppression in Crohn's Disease Treated With Scheduled Infliximab Maintenance: A Randomized Trial
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Patient disposition throughout the trial. Patients achieving the primary end point of needing a change in IFX dosing schedule, including stopping IFX dosing, are represented first. Patients who stoppe
Patient disposition throughout the trial. Patients achieving the primary end point of needing a change in IFX dosing schedule, including stopping IFX dosing, are represented first. Patients who stopped further infliximab dosing are also listed separately.
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Life table analysis (Kaplan–Meier) of the patient outcomes. (A) Analysis in both groups of the need for early rescue IFX or stopping IFX therapy (primary end point). (B) Analysis in both groups of theLife table analysis (Kaplan–Meier) of the patient outcomes. (A) Analysis in both groups of the need for early rescue IFX or stopping IFX therapy (primary end point). (B) Analysis in both groups of the need to stop further IFX therapy. P values are listed for the log-rank test only.
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CRP (A) and IFX trough levels (B) in both groups throughout the trial. In the graphs with individual time points, data are represented as medians and IQR. The dotted line in panel A marks the upper liCRP (A) and IFX trough levels (B) in both groups throughout the trial. In the graphs with individual time points, data are represented as medians and IQR. The dotted line in panel A marks the upper limit of normal for CRP (5 mg/L). Levels of significance are indicated when appropriate. Numbers below the x-axis in panel B represent the number of patients still on the trial, who had not achieved the primary end point.
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Proportion of patients with undetectable IFX trough serum levels in both arms and at different time points throughout the trial. Data are expressed as percentage of patients still on the trial (for paProportion of patients with undetectable IFX trough serum levels in both arms and at different time points throughout the trial. Data are expressed as percentage of patients still on the trial (for patient numbers see Figure 3B).
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CRP levels and CDAI scores in all patients measured at all study time points expressed as a function of trough serum IFX levels (μg/mL). Trough levels below 0.3 μg/mL and below 2 μg/mL were associatedCRP levels and CDAI scores in all patients measured at all study time points expressed as a function of trough serum IFX levels (μg/mL). Trough levels below 0.3 μg/mL and below 2 μg/mL were associated with elevated median CRP levels. CDAI was not affected by trough IFX levels.
Support for study was not funded externally.Conflicts of interest that have been disclosed to study participants: Geert D'Haens, Paul Rutgeerts, and Gert Van Assche: Research support from Centocor and Schering Plough, Speaker's bureau of Schering Plough, consultancy for Centocor and Schering-Plough. Charlotte Magdelaine–Beuzelin: no conflict of interest. Filip Baert: no conflict of interest. Maja Noman: no conflict of interest. Séverine Vermeire: Speaker's bureau Schering-Plough. David Ternant: no conflict of interest. Hervé Watier: no conflict of interest. Gilles Paintaud: no conflict of interest. Paul Rutgeerts: Research support from Schering-Plough and Centocor.
PII: S0016-5085(08)00435-6
doi: 10.1053/j.gastro.2008.03.004
© 2008 AGA Institute. Published by Elsevier Inc. All rights reserved.
« Previous
Next »
Gastroenterology
Volume 134, Issue 7
, Pages
1861-1868
, June 2008

