Abstract
Background It remains unknown whether infliximab (IFX) successfully can be discontinued once Crohn's disease (CD) patients have attained sustained, complete clinical, biochemical, and endoscopic remission. No randomized, placebo (PBO) controlled trial has previously assessed this. Methods This double-blind, randomized, PBO-controlled multicenter trial enrolled patients with luminal CD who had been treated with standard IFX maintenance therapy for at least 1 year, in complete remission at the time of inclusion defined as CD Activity Index (CDAI) 150 with an increase in CDAI >70-point from baseline over two consecutive weeks; or definitive clinical relapse requiring immediate intervention as judged by treating physician) in the intention-to-treat population. Results The study population comprised 115 patients (n=54 female; age median 34 years [IQR 26-50]; disease duration median 6 years [3-12]; IFX treatment duration median 23 months [16-39]). All patients were in combined clinical- (CDAI median 41 [IQR 15-66]), biochemical- (CRP median 3mg/L [IQR 2-4]), and endoscopic- (Simple Endoscopic Score for CD median 0, [IQR 0-0] (n=99)) remission. Patients were randomized to continued IFX therapy (n=59) or to start PBO infusions (n=56) (Figure 1). Time to relapse was significantly shorter among patients who discontinued IFX as compared to those continuing IFX (p 150) the figures were 47% in the PBO group vs. 98% in IFX group (p Conclusion This first double-blinded placebo-controlled RCT of IFX withdrawal in Crohn's disease patients strongly suggests that discontinuation of IFX leads to a considerable risk of relapse despite combined clinical, biochemical, and endoscopic remission. Download : Download high-res image (53KB) Download : Download full-size image Download : Download high-res image (56KB) Download : Download full-size image
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