The Efficacy and Safety of Infliximab in Pediatric Crohnʼs Disease in China

Abstract

BACKGROUND: Few studies have examined the efficacy and safety of infliximab (IFX) in pediatric Crohn's disease (CD) in China. This study aimed to investigate the response and remission rate of IFX, as well as the associated adverse events. METHODS: We collected data from CD patients who had received IFX 2 or more times from three hospitals in Shanghai from January 2007 to December 2016. The efficacy of IFX was observed, as well as the adverse events, relapse rate and retreatment efficacy. The overall risk factors related to IFX were also evaluated. RESULTS: Eighty-six patients participated in the study. With treatment, the patients demonstrated improved growth and nutrition indices and decreased disease activity. The clinical response rate was 91.9% and 88.2% at weeks 10 and 34, respectively. The sustained remission rates were 69.8% and 67.6% at weeks 10 and 34, respectively. The mucous healing rate was 19.3% at week 10 and 25.7% at week 34. Finally, 45 patients (66.2%) demonstrated durable responses, and 23 (33.8%) showed complete LOR. Adverse events related to IFX occurred in 55.8% of the patients, including allergic reactions in 17.4% and infections in 41.9%. Univariate analysis showed that a high pediatric clinical disease activity index score prior to IFX administration was a risk factor for IFX LOR. Continuation of concomitant azathioprine beyond induction was a protective factor for durable response. CONCLUSION(S): IFX is an effective treatment for CD in Chinese children; however, adverse events can occur. A comprehensive evaluation must be performed before each IFX infusion.