Background: Targeting tumour necrosis factor α(TNF-α) has demonstrated effi cacy in Crohn’s disease. Aim: To evaluate CDP571, a humanised antibody to TNF- α, for treating active Crohn’s disease. Patients: A total...Background: Targeting tumour necrosis factor α(TNF-α) has demonstrated effi cacy in Crohn’s disease. Aim: To evaluate CDP571, a humanised antibody to TNF- α, for treating active Crohn’s disease. Patients: A total of 396 patients with moderate to severe Crohn’s disease. Methods: In a 28 week, randomised, double blind, placebo controlled trial, patients received intravenous CDP571 (10 mg/kg) or placebo every eight weeks to week 24. The primary outcome measure was clinic al response (a decrease in the Crohn’s disease activity index (CDAI) to ≥100 p oints or remission (CDAI score ≤150 points)) at week 28. A secondary outcome me asure was clinical response (using the same definition) at week 2. Results: Clin ical response occurred at week 28 in 80/263 (30.4%) CDP571 patients and 31/132 (23.5%) placebo patients (p = 0.102). Clinical response at week 2 occurred in 9 0/263 (34.2%) CDP571 patients and 28/132 (21.2%) placebo patients (p = 0.011). Post hoc exploratory subgroup analysis of 159 patients with baseline C reactive protein (CRP) ≥10 mg/l demonstrated significant differences between CDP571 and placebo in clinical response rates at weeks 2 (CDP571, 50/101 (49.5%); placebo , 9/58 (15.5%); p<0.001) and 28 (CDP571, 29/101 (28.7%); placebo, 7/58 (12.1% ); p = 0.018). Adverse events occurred at similar frequencies in both treatment groups. Conclusions: CDP571 is modestly effective for short but not long term tr eatment of unselected patients with moderate to severe Crohn’s disease. The cli nical relevance of this short term effect is unclear. Post hoc analysis suggests both short and long term efficacy of CDP571 in patients with elevated baseline CRP (≥10 mg/l). CDP571 is well tolerated.展开更多
在最近召开的美国大学风湿病学国际会议(American College of Rheumatology National Scientific)上,首次介绍了用一种潜在的新细胞技术药物CDP571治疗类风湿性关节炎的Ⅱ期临床试验的研究情况。该药是一种新的人性化抗体,能够阻断肿瘤...在最近召开的美国大学风湿病学国际会议(American College of Rheumatology National Scientific)上,首次介绍了用一种潜在的新细胞技术药物CDP571治疗类风湿性关节炎的Ⅱ期临床试验的研究情况。该药是一种新的人性化抗体,能够阻断肿瘤坏死因子(TNF)的作用。TNF是在运动中起关键作用的炎性蛋白,能导致类风湿病患者的关节损伤。阻断TNF的活动将有益于患者。类风湿性关节炎(RA)是一种慢性疾病,它能引起关节的疼痛、肿胀和损害,以及其它器官的炎症,并丧失劳动能力。在英国大约有50万人患此病,而美国患此病的人超过2百万。RA的发病高峰在20岁到45岁之间。展开更多
文摘Background: Targeting tumour necrosis factor α(TNF-α) has demonstrated effi cacy in Crohn’s disease. Aim: To evaluate CDP571, a humanised antibody to TNF- α, for treating active Crohn’s disease. Patients: A total of 396 patients with moderate to severe Crohn’s disease. Methods: In a 28 week, randomised, double blind, placebo controlled trial, patients received intravenous CDP571 (10 mg/kg) or placebo every eight weeks to week 24. The primary outcome measure was clinic al response (a decrease in the Crohn’s disease activity index (CDAI) to ≥100 p oints or remission (CDAI score ≤150 points)) at week 28. A secondary outcome me asure was clinical response (using the same definition) at week 2. Results: Clin ical response occurred at week 28 in 80/263 (30.4%) CDP571 patients and 31/132 (23.5%) placebo patients (p = 0.102). Clinical response at week 2 occurred in 9 0/263 (34.2%) CDP571 patients and 28/132 (21.2%) placebo patients (p = 0.011). Post hoc exploratory subgroup analysis of 159 patients with baseline C reactive protein (CRP) ≥10 mg/l demonstrated significant differences between CDP571 and placebo in clinical response rates at weeks 2 (CDP571, 50/101 (49.5%); placebo , 9/58 (15.5%); p<0.001) and 28 (CDP571, 29/101 (28.7%); placebo, 7/58 (12.1% ); p = 0.018). Adverse events occurred at similar frequencies in both treatment groups. Conclusions: CDP571 is modestly effective for short but not long term tr eatment of unselected patients with moderate to severe Crohn’s disease. The cli nical relevance of this short term effect is unclear. Post hoc analysis suggests both short and long term efficacy of CDP571 in patients with elevated baseline CRP (≥10 mg/l). CDP571 is well tolerated.
文摘在最近召开的美国大学风湿病学国际会议(American College of Rheumatology National Scientific)上,首次介绍了用一种潜在的新细胞技术药物CDP571治疗类风湿性关节炎的Ⅱ期临床试验的研究情况。该药是一种新的人性化抗体,能够阻断肿瘤坏死因子(TNF)的作用。TNF是在运动中起关键作用的炎性蛋白,能导致类风湿病患者的关节损伤。阻断TNF的活动将有益于患者。类风湿性关节炎(RA)是一种慢性疾病,它能引起关节的疼痛、肿胀和损害,以及其它器官的炎症,并丧失劳动能力。在英国大约有50万人患此病,而美国患此病的人超过2百万。RA的发病高峰在20岁到45岁之间。
