An engineered human antibody to TNF (CDP571) for active Crohn's disease: A randomized double-blind placebo-controlled trial

摘要: Abstract Background & Aims: We evaluated CDP571, a humanized antibody to tumor necrosis factor, for the treatment of active Crohn's disease. Methods: One hundred sixty-nine patients with moderate-to-severe disease were enrolled in 24-week placebo-controlled trial. Patients initially randomized single dose 10 or 20 mg/kg CDP571 placebo assess response. then retreated every 8 12 weeks subsequent dosing intervals. The primary endpoint was clinical response at week 2, defined as decrease Disease Activity Index score ≥ 70 points. Results: At occurred 45% CDP571-treated compared 27% group ( P = 0.023). appeared benefit from retreatment over 24 weeks, but not all results secondary endpoints statistically significant. frequency severe serious adverse events similar among groups. Conclusions: an initial is safe and effective Preliminary evidence suggests that intervals may also be beneficial, additional studies are needed. GASTROENTEROLOGY 2001;120:1330-1338