Clinical–Alimentary TractWithdrawal of Immunosuppression in Crohn's Disease Treated With Scheduled Infliximab Maintenance: A Randomized Trial
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Study Design
All patients ages 16 years or older and having received IFX in an episodic or systematic maintenance schedule were eligible if they had been treated with a combination of IFX 5 mg/kg IV dosed with intervals of 8 weeks or longer and an appropriate dose of immunosuppressives (azathioprine/6-mercaptopurine or methotrexate) for at least 6 months and provided they met all other inclusion criteria and none of the exclusion criteria. Appropriate dose of immunosuppressives was defined for azathioprine
Patient Demographics
Forty patients were included and randomized in each arm between February 2004 and May 2005 (Figure 1). As shown in Table 1, there were no differences between the groups for age, sex, smoking status, weight, duration of disease, baseline CDAI and CRP, disease location, duration of IFX or immunosuppressives therapy, type of immunosuppressive, and previous IFX maintenance strategy (Table 1). None of the patients had received a loading scheme with IFX 5 mg/kg at 0, 2, and 6 weeks because this
Discussion
The benefit of conventional immunosuppressives such as thiopurines and methotrexate in combination with scheduled IFX maintenance therapy is still debated. In this study, we aimed to investigate the additional benefit of immunosuppressives continuation in patients with luminal CD treated with scheduled IFX maintenance beyond the induction period. We found no advantage of continuing immunosuppressives for clinical outcomes including mucosal healing. However, the combined treatment approach
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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.