Primary studies on clinical efficacy of infliximab in Crohn′s disease and its effects on mucosal healing / 中华消化杂志

ABSTRACT

Objective To evaluate the clinical efficacy of infliximab (IFX) in Crohn′s disease (CD) and its effects on mucosal healing and promoting fistula closure.Methods Between September 2007 and February 2011,relevant clinical data of CD patients treated with IFX in the Department of Gastroenterology,Ruijin Hospital were collected and the efficacy and safety of IFX were retrospectively analyzed.After IFX therapy,the efficacy evaluation included laboratory index,clinical efficacy,efficacy of fistula closure and mucosal healing.The data were analyzed using t test and Wilcoxon signed-rank test.Results A total of 22 patients were enrolled in this study,11 males and 11 females; the mean age was 29.3 years.The dosage of IFX was 5 mg/kg to 10 mg/kg at week 0,2,6to induce remission,and every 8 weeks on maintenance therapy.Of 22 patients,16 patients were active CD.One case dropped out.At week 14,of the remaining 15 cases,11 cases achieved clinical remission,two cases achieved clinically effective and two cases were ineffective.Crohn′s disease activity index (CDAI) (112±80) and ESR [(13±11) mm/1 h] of week 14 decreased compared with that of week 0 [(186±88),(21± 15) mm/1 h,P=0.04 and 0.007].Two cases of 10 patients with fistula dropped out as a result of ineffective,while eight cases had a partial response and six patients sustained response during the maintenance therapy,but no fistula closed and completely disappear.Seven patients reviewed by endoscopy after five times IFX therapy (24 weeks),after therapy the simple endoscopic score for Crohn′ s disease (SES-CD) ( 3.21 ± 2.89 ) decreased compared with that before treatment (5.86±3.02) (Z＝-2.38,P＝0.018).Eleven times of adverse events were found in nine patients,infusion reaction and respiratory tract infection were more common and no severe adverse effect was observed.Conclusions IFX can rapidly improve clinical symptoms and with good safety.The effects in mucosal healing and fistula closure may occur at early medication.