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

  • Gert Van Assche

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
    • Corresponding Author InformationAddress requests for reprints to: Gert Van Assche, MD, PhD, Division of Gastroenterology, University of Leuven Hospitals, 49-Herestraat, 3000 Leuven, Belgium. fax: (32) 1624419.
  • ,
  • Charlotte Magdelaine–Beuzelin

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
  • ,
  • Geert D'Haens

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
    • Imelda Clinical trials Center, Imelda Hospital, Bonheiden, Belgium
  • ,
  • Filip Baert

      Affiliations

    • Heilig Hart Ziekenhuis Roeselare, Roeselare, Belgium
  • ,
  • Maja Noman

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
  • ,
  • Séverine Vermeire

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
  • ,
  • David Ternant

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
  • ,
  • Hervé Watier

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
  • ,
  • Gilles Paintaud

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
  • ,
  • Paul Rutgeerts

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium

Received 16 October 2007 ,Accepted 6 March 2008.

  • Image Result

    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.

  • Image Result
    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 the

    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 the need to stop further IFX therapy. P values are listed for the log-rank test only.

  • Image Result
    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 li

    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 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.

  • Image Result
    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 pa

    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 patient numbers see Figure 3B).

  • Image Result
    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 associated

    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 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

Gastroenterology
Volume 134, Issue 7 , Pages 1861-1868 , June 2008