Background:
Thiopurines are considered first-line immunomodulators for the prevention of relapse in moderate to severe pediatric crohn's disease (cd). early introduction of thiopurines was shown in a pediatric trial to maintain steroid-free remission in 90% of patients for 18 months. in the present study we analyzed the tolerance and efficacy of azathioprine (aza) to maintain remission in a homogenous single-center observational cohort of children with cd.
Methods:
In all, 105 pediatric cd patients (male/female 68/37) were retrospectively evaluated for the efficacy of aza (doses 1.4-4 mg/kg) to maintain remission at 6, 12, 18, and 24 months of follow-up. overall, 93 children were included with active disease (pediatric crohn's disease activity index [pcdai] >30), steroid/enteral-nutrition dependency, or postileocecal resection. remission was defined as pcdai ≤10 without steroids. patients requiring antitumor necrosis factor (tnf) medication, other immunomodulators, or surgery were considered to experience a relapse.
Results:
Based on pcdai, steroid-free remission was achieved in 56/93 (60.2%), 37/93 (39.8%), 31/93 (33.3%), and 29/93 (31.2%) at visits month (m)6, m12, m18, and m24, respectively. within the first 4 weeks, aza was stopped in 10/93 patients due to adverse reactions (pancreatitis, nausea, vomiting, skin reactions, general weakness), or not introduced due to low thiopurine methyl transferase (tpmt) activity (n = 3). no neutropenia occurred in patients with normal tpmt activity. three infectious episodes were documented requiring temporary aza suspension.
Conclusions:
Aza is efficacious in maintaining remission in pediatric cd patients, but to a lesser extent than previously suggested. the majority of patients who are in steroid-free remission at 12 months remained in prolonged remission. overall tolerance of aza was excellent.