title: Low-dose Infliximab for Induction and Maintenance Treatment in Chinese Patients With Moderate to Severe Active Ulcerative Colitis.
abstract: OBJECTIVE
  To evaluate the efficacy of low-dose (3.5 mg/kg) infliximab for induction and maintenance treatment in Chinese patients with ulcerative colitis.
  
  
  BACKGROUND
  Treatment with 4 to 5 mg/kg of infliximab also proved to be effective in treating moderate to severe ulcerative colitis. At present there is no relevant study on the effectiveness of infliximab doses lower than 4 mg/kg in patients with ulcerative colitis.
  
  
  METHODS
  A prospective, randomized, double-blind, placebo-controlled, and single-centered study was designed. A total of 123 patients (from 17 provinces of China) with moderate to severe active ulcerative colitis despite treatment with concurrent drugs received placebo or low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab intravenously at weeks 0, 2, and 6 and then every 8 weeks through week 22. Patients were followed up for 30 weeks.
  
  
  RESULTS
  Overall, 73% and 78% of patients who received low-dose (3.5 mg/kg) and standard-dose (5 mg/kg) infliximab, respectively, had clinical responses at week 8, as compared with 37% of patients who received placebo (P<0.01 for both comparisons with placebo). The number of patients who received low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab with a clinical response at week 30 (63% and 66%, respectively) was more than the patients who received placebo (27%, P<0.01 for both comparisons).
  
  
  CONCLUSIONS
  Chinese patients with moderate to severe active ulcerative colitis treated with low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter were more likely to have a clinical response at weeks 8 and 30 than those who received placebo.
authors.affiliation: *Department of Gastroenterology, Chinese PLA General Hospital of Jinan Military Command †College of Pharmaceutical Science, Shandong University, Jinan, Shandong Province, China.
authors.forename: Xue-Liang
authors.initials: XL
authors.lastname: Jiang
authors.forename: Hui-Fei
authors.initials: HF
authors.lastname: Cui
authors.forename: Jing
authors.initials: J
authors.lastname: Gao
authors.forename: Hua
authors.initials: H
authors.lastname: Fan
mesh_terms: D000328:Adult; D002681:China; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D060828:Induction Chemotherapy; D000069285:Infliximab / Q000008:administration & dosage*; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D000069285:Infliximab