Rutgeerts Paul, Sandborn William J, Fedorak Richard N, Rachmilewitz Daniel, Tarabar Dino, Gibson Peter, Haagen Nielsen Ole, Wild Gary, Schreiber Stefan, Pena Rossi Claudia, Zignani Monia
University Hospital Gasthuisberg, Leuven, Belgium.
Clin Gastroenterol Hepatol. 2006 Jul;4(7):888-93. doi: 10.1016/j.cgh.2006.04.022. Epub 2006 Jun 22.
Onercept is a recombinant, soluble human p55 receptor to tumor necrosis factor-alpha.
A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of onercept induction therapy in patients with Crohn's disease (CD). Patients (n = 207) with moderate-to-severe acute or chronic active CD were randomized to receive subcutaneous onercept (10, 25, 35, or 50 mg) or placebo 3 times weekly for 8 weeks. Primary analysis was induction of remission (defined as a CD activity index score < or = 150) at week 8.
A total of 104 patients had acute active CD. Remission rates at week 8 were 23.5% for placebo (n = 17), and 34.8%, 20.0%, 26.1%, and 28.6% for onercept 10 mg (n = 23), 25 mg (n = 20), 35 mg (n = 23), and 50 mg (n = 21), respectively (P = .98). A total of 103 patients had chronic active CD. Remission rates at week 8 were 23.8% for placebo (n = 21), and 23.8%, 9.1%, 35.3%, and 13.6% for onercept 10 mg (n = 21), 25 mg (n = 22), 35 mg (n = 17), and 50 mg (n = 22), respectively (P = .66). There were no differences between treatment groups in the incidence of adverse events. However, mild-to-moderate injection-site reactions occurred in up to 12% of onercept-treated patients.
Onercept was well tolerated but was not effective at the doses studied in patients with active CD.
奥纳昔普是一种重组可溶性人肿瘤坏死因子-α p55受体。
进行了一项随机、双盲、安慰剂对照、剂量范围试验，以评估奥纳昔普诱导治疗对克罗恩病（CD）患者的疗效。207例中度至重度急性或慢性活动性CD患者被随机分组，每周皮下注射奥纳昔普（10、25、35或50毫克）或安慰剂3次，共8周。主要分析为第8周时的缓解诱导（定义为CD活动指数评分≤150）。
共有104例患者为急性活动性CD。安慰剂组（n = 17）第8周的缓解率为23.5%，奥纳昔普10毫克组（n = 23）为34.8%，25毫克组（n = 20）为20.0%，35毫克组（n = 23）为26.1%，50毫克组（n = 21）为28.6%（P = 0.98）。共有103例患者为慢性活动性CD。安慰剂组（n = 21）第8周的缓解率为23.8%，奥纳昔普10毫克组（n = 21）为23.8%，25毫克组（n = 22）为9.1%，35毫克组（n = 17）为35.3%，50毫克组（n = 22）为13.6%（P = 0.66）。各治疗组不良事件发生率无差异。然而，高达12%接受奥纳昔普治疗的患者出现轻至中度注射部位反应。
奥纳昔普耐受性良好，但在所研究剂量下对活动性CD患者无效。
