CDP571, a humanised monoclonal antibody to tumour necrosis factor  , for moderate to severe Crohn's disease: a randomised, double blind, placebo controlled trial

摘要: Background: Targeting tumour necrosis factor α (TNF-α) has demonstrated efficacy in Crohn’s disease. Aim: To evaluate CDP571, a humanised antibody to TNF-α, for treating active Patients: A total of 396 patients with moderate severe Methods: In 28 week, randomised, double blind, placebo controlled trial, received intravenous CDP571 (10 mg/kg) or every eight weeks week 24. The primary outcome measure was clinical response (a decrease the disease activity index (CDAI) ⩾100 points remission (CDAI score ⩽150 points)) at 28. secondary (using same definition) 2. Results: Clinical occurred 80/263 (30.4%) and 31/132 (23.5%) (p = 0.102). 2 90/263 (34.2%) 28/132 (21.2%) (p = 0.011). Post hoc exploratory subgroup analysis 159 baseline C reactive protein (CRP) ⩾10 mg/l significant differences between rates (CDP571, 50/101 (49.5%); placebo, 9/58 (15.5%); p Conclusions: is modestly effective short but not long term treatment unselected relevance this effect unclear. suggests both elevated CRP (⩾10 mg/l). well tolerated.