Background: Few studies have reported factors associated with intestinal resection in patients with Crohn's disease (CD) treated with adalimumab (ADA). We investigated incidence of intestinal resection and the factors related to the requirement of intestinal resection in patients who participated in the Adalimumab Japanese Multicentre Cohort Study of Crohn's disease (ADJUST).
Methods: Data were retrospectively collected from all patients with CD who had received at least one induction dose of 160 mg of ADA between October 2010 and December 2013. Patients with active CD received ADA as induction of remission were included, while those with inactive CD started on ADA for prevention of postoperative recurrence were excluded. The cumulative rates of intestinal resection following the first administration of ADA were estimated by the Kaplan–Meier method. We also investigated the cumulative rate of intestinal resection and the related prognostic factors stratified by prior use of infliximab (IFX). Prognostic factors related to the cumulative rates of intestinal resection were evaluated by log-rank tests and multivariate Cox regression analysis.
Results: A total of 966 patients (median age, 33.6 years; female, 31%) were included in the study. The median duration of CD was 7.6 years. Forty-four percent of the patients with active CD who required induction of remission with ADA had undergone prior intestinal resection. Concomitant treatment with immunomodulators (IMs) and prednisolone (PSL) was administered to 38% and 16% of the patients, respectively. Forty-nine percent of the patients had been previously treated with IFX (IFX exposed group), and 51% were naïve to IFX (IFX naïve group). The 1-, 2-, 3- and 4-year cumulative rates of intestinal resection were 10%, 17%, 24% and 35%, respectively. The cumulative rates of intestinal resection were significantly higher in the IFX exposed group than in the IFX naïve group. In the IFX exposed group, the multivariate Cox regression analysis demonstrated stricturing or penetrating disease, ≤3.7 g/dL of serum albumin, without prior intestinal resection and concomitant treatment with PSL as independent predictors of high rates of intestinal resection, and the association between concomitant treatment with IMs and significant reduction of the incidence of intestinal resection. In IFX naïve patients, stricturing or penetrating disease was an independent predictor of high rates of intestinal resection. However, concomitant treatment with IMs was not associated with rates of intestinal resection in IFX naïve patients.
Conclusions: Our data suggested that combination therapy of ADA and IMs significantly decreased the rates of intestinal resection, particularly in CD patients previously treated with IFX.