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首页> 外文期刊>Prescrire international >Certolizumab pegol: new drug. As a last resort in Crohn's disease: continue to use other TNF alpha inhibitors.
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Certolizumab pegol: new drug. As a last resort in Crohn's disease: continue to use other TNF alpha inhibitors.

机译：Certolizumab聚乙二醇：新药。作为克罗恩氏病的不得已之计：继续使用其他TNFα抑制剂。

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(1) Infliximab and adalimumab, two TNF alpha-inhibitor immunosuppressants, are both available for use as a last resort in Crohn's disease. They are effective in about one in two patients but they carry a risk of serious infections, lymphoma and aggravation of heart failure; (2) Certolizumab is a new TNF alpha-inhibitor monoclonal antibody. It is pegylated to prolong its action, hence the name certolizumab pegol; (3) Certolizumab is sold in the United States for the treatment of Crohn's disease, after failure of conventional treatments. However, the European authorities issued a negative opinion on this drug, and the European Commission refused to grant marketing authorization on 21 May 2008. It is nonetheless available for named-patient compassionate use in France; (4) Certolizumab pegol has not been compared directly with infliximab or adalimumab; (5) In a double-blind placebo-controlled trial including 662 adults with an exacerbation of Crohn's disease, a 6-month course of certolizumab pegol reduced symptom intensity in slightly more patients than placebo (23% versus 16%). However, the rate of clinical remissions was similar (about 12% of patients overall); (6) In a placebo-controlled trial in 428 patients with an initial critical response to certolizumab pegol, maintaining this treatment for 6 months was more effective than switching to placebo. Clinical remissions were obtained at the end of treatment in respectively 48% and 29% of patients; (7) These short-term trials showed a higher frequency of infections with certolizumab pegol than with placebo; these infections ranged from mild respiratory tract infections to fatal tuberculosis. Some patients also developed autoantibodies and anti-certolizumab pegol antibodies, but the clinical implications are unclear. There is also evidence of an excess risk of haemorrhage. The risk of long-term adverse effects remains to be determined; (8) Certolizumab pegol is injected subcutaneously, once a month, on an outpatient basis, while adalimumab is injected twice a month; (9) In practice, as with other TNF alpha inhibitors used in Crohn's disease, certolizumab pegol is only modestly effective and carries a disturbing risk of adverse effects. In the absence of a better alternative, patients with Crohn's disease who might benefit from TNF alpha inhibitor therapy should continue to receive either infliximab or adalimumab, two drugs with which we have more experience.
机译：（1）英夫利昔单抗和阿达木单抗是两种TNFα抑制剂免疫抑制剂，均可作为克罗恩病的最后手段。它们对大约二分之一的患者有效，但存在严重感染，淋巴瘤和心力衰竭加重的风险; （2）Certolizumab是一种新的TNFα抑制剂单克隆抗体。它被聚乙二醇化以延长其作用，因此名称为certolizumab聚乙二醇。 （3）在常规治疗失败后，西妥昔单抗在美国出售，用于治疗克罗恩氏病。但是，欧洲当局对该药发表了负面意见，欧洲委员会于2008年5月21日拒绝授予该药品的销售许可。 （4）尚未将西妥昔单抗培高洛尔与英夫利昔单抗或阿达木单抗直接比较; （5）在一项包括662名克罗恩氏病加重的成人的双盲安慰剂对照试验中，塞托珠单抗聚乙二醇6个月疗程可使患者的症状强度比安慰剂稍多（23％对16％）。但是，临床缓解率相似（总体约占患者的12％）。 （6）在安慰剂对照试验中，对428例最初对塞妥珠单抗有严重反应的患者，维持该治疗6个月比改用安慰剂更有效。治疗结束时分别有48％和29％的患者获得了临床缓解。 （7）这些短期试验显示，certolizumab聚乙二醇（pegol）的感染频率高于安慰剂。这些感染的范围从轻度呼吸道感染到致命的结核病。一些患者还发展了自身抗体和抗-certolizumab聚乙二醇抗体，但临床意义尚不清楚。也有证据表明有大出血风险。长期不良影响的风险尚待确定; （8）门诊患者每月一次皮下注射Certolizumab聚乙二醇，而阿达木单抗则每月注射两次; （9）实际上，与克罗恩氏病中使用的其他TNFα抑制剂一样，塞妥珠单抗聚乙二醇乙二醇酯仅适度有效，并具有令人不安的不良反应风险。在没有更好的选择的情况下，可能从TNFα抑制剂治疗中受益的克罗恩病患者应继续接受英夫利昔单抗或阿达木单抗，这是我们拥有更多经验的两种药物。

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    《Prescrire international》 |2009年第101期|共3页
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