Abstract

Few studies have demonstrated treatment strategies about the duration and cessation of medications in patients with Crohn’s disease (CD). We investigated factors affecting clinical relapse after infliximab (IFX) or azathioprine (AZA) withdrawal in pediatric patients with CD on combination therapy. Pediatric patients with moderate-to-severe CD receiving combination therapy were analyzed retrospectively and factors associated with clinical relapse were investigated. Discontinuation of IFX or AZA was performed in patients who sustained clinical remission (CR) for at least two years and achieved deep remission. A total of 75 patients were included. Forty-four patients (58.7%) continued with combination therapy and 31 patients (41.3%) discontinued AZA or IFX (AZA withdrawal 10, IFX withdrawal 15, both withdrawal 6). Cox proportional-hazards regression and statistical internal validation identified three factors associated with clinical relapse: IFX cessation (hazard ratio; HR 2.982, P = 0.0081), IFX TLs during maintenance therapy (HR 0.581, P = 0.003), 6-thioguanine nucleotide (6-TGN) level (HR 0.978, P < 0.001). However, AZA cessation was not associated with clinical relapse (P = 0.9021). Even when applied in pediatric patients who met stringent criteria, IFX cessation increased the relapse risk. However, withdrawal of AZA could be contemplated in pediatric patients with CD who have sustained CR for at least 2 years and achieved deep remission.

Highlights

  • Few studies have demonstrated treatment strategies about the duration and cessation of medications in patients with Crohn’s disease (CD)

  • From January 2012 to March 2018, a total of 216 pediatric patients were diagnosed with CD and of these 75 patients were considered eligible for analysis as shown in the flow diagram for patient selection (Fig. 1)

  • We investigated the factors affecting clinical relapse and estimated the optimum duration and time of cessation of medication in moderate to severe pediatric CD treated with combination therapy

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Summary

Introduction

Few studies have demonstrated treatment strategies about the duration and cessation of medications in patients with Crohn’s disease (CD). We investigated factors affecting clinical relapse after infliximab (IFX) or azathioprine (AZA) withdrawal in pediatric patients with CD on combination therapy. Pediatric patients with moderate-to-severe CD receiving combination therapy were analyzed retrospectively and factors associated with clinical relapse were investigated. It is well known that corticosteroidfree clinical remission (CR) is more likely to be achieved in patients with moderate-to-severe CD when treated with a combination therapy that includes IFX plus azathioprine (AZA) or with IFX monotherapy, than in those receiving AZA m­ onotherapy[4]. The aim of this study was to determine factors affecting clinical relapse after achieving remission in pediatric CD and to estimate the proper duration and time of cessation of early combination therapy in a selected population of pediatric patients with CD in a real-life cohort

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