Long-term risk of infection in patients with Crohn's disease on anti-TNF treatment: A prospective single-center cohort study in China.

Objective: The aim of this study was to explore the long-term risk of infection in patients with Crohn's disease (CD) on infliximab (IFX) therapy.

Methods: All CD patients treated with IFX were recruited from January 2008 to December 2015. Their characteristics and infectious events during IFX therapy were prospectively collected, and the risk of infection was evaluated using Cox regression.

Results: Seventy CD patients receiving IFX were consecutively recruited. During a median of 15 months, 15 patients experienced 17 infectious events which occurred within a median of 21 weeks after the initiation of IFX therapy. Of 17 infectious events, eight were viral infections, six were bacterial infections, and the others were fungal infections. IFX was discontinued in 6 (40.0%) out of 15 cases due to infections. Compared with those without infections, patients with infectious events were more likely of Montreal B1 (inflammatory) behavior, with concomitant use of systemic corticosteroids when infliximab was started but less mucosal healing when infections occurred (P < 0.05). By Cox hazard ratio (HR) analysis, patients with B1 behavior had a higher risk of developing infections than those with B3 (fistulizing) behavior (HR 4.897, P = 0.010). Successful corticosteroid withdrawal (HR 0.275, P = 0.035) or mucosal healing (HR 0.155, P = 0.002) were associated with a lower risk of infections.

Conclusions: Long-term use of IFX in CD patients has a high risk of infections. Failure in mucosal healing and increased concomitant use of systemic corticosteroids are independent risk factors of infections during IFX therapy.