Discontinuation of Azathioprine Could Be Considered in Pediatric Patients with Crohn’s Disease who Have Sustained Clinical and Deep Remission

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 identified four factors associated with clinical relapse: IFX cessation (hazard ratio; HR 2.982, P= 0.0081), formation of antibody-to-IFX (ATI) (HR=3.12, P= 0.0373), IFX trough level (TL) (HR=0.581, P= 0.003) and 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 meet 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 two years and achieved deep remission.