School of Pharmacy, Wingate University, Wingate, NC, USA.
Ann Pharmacother. 2010 Feb;44(2):333-42. doi: 10.1345/aph.1M314. Epub 2010 Jan 5.
To review certolizumab pegol for the treatment of moderate-to-severe Crohn's disease (CD).
Clinical studies were identified through MEDLINE (1966-October 1, 2009), bibliographies of articles, International Pharmaceutical Abstracts, clinicaltrials.gov, fda.gov, and New Drug Approval documents (www.accessdata.fda.gov). Search terms were CDP 870, certolizumab pegol, Cimzia, Crohn's disease, and inflammatory bowel disease.
Human studies describing pharmacology, pharmacokinetics, efficacy, and safety of certolizumab pegol were identified. Phase 2 and Phase 3 randomized controlled trials and observational studies were reviewed, with emphasis given to Phase 2 and Phase 3 trials.
Certolizumab pegol is a tumor necrosis factor-alfa (TNF-alpha) antagonist, approved for the treatment of moderate-to-severe CD that is failing conventional therapy. It is an antigen-binding fragment (Fab') portion of an immunoglobulin G antibody attached to a polyethylene glycol moiety. In 2 Phase 3 randomized, placebo-controlled trials, certolizumab pegol was effective in inducing clinical response compared with placebo. Common adverse effects during clinical trials were upper respiratory tract infection, urinary tract infection, and arthralgia. Serious infection occurred in 3% of patients. The 4 published controlled trials for the use of certolizumab pegol in the treatment of CD share similar limitations with other studies of TNF-alpha antagonists including high placebo response, natural course of disease fluctuation, and the use of Crohn's Disease Activity Index to assess outcomes. However, certolizumab pegol is an effective agent for adults with moderate-to-severe CD with less than optimal response to conventional therapy. Long-term efficacy and safety data are unavailable. Certolizumab pegol and adalimumab, unlike infliximab, can be self-administered.
With similarity in cost and the lack of head-to-head comparisons, patient and physician preference may determine choice of TNF-alpha antagonist.
综述培塞利珠单抗治疗中重度克罗恩病（CD）的情况。
通过 MEDLINE（1966 年 10 月 1 日至 2009 年）、文章的参考文献、国际药学文摘、clinicaltrials.gov、fda.gov 和新药批准文件（www.accessdata.fda.gov）检索临床研究。检索词包括 CDP870、培塞利珠单抗、Cimzia、克罗恩病和炎症性肠病。
确定了描述培塞利珠单抗药理学、药代动力学、疗效和安全性的人体研究。对 2 期和 3 期随机对照试验和观察性研究进行了综述，重点是 2 期和 3 期试验。
培塞利珠单抗是肿瘤坏死因子-α（TNF-α）拮抗剂，批准用于治疗对常规治疗反应不佳的中重度 CD。它是一种免疫球蛋白 G 抗体的抗原结合片段（Fab'）与聚乙二醇部分连接而成。在 2 项 3 期随机、安慰剂对照试验中，培塞利珠单抗在诱导临床缓解方面优于安慰剂。临床试验中常见的不良反应包括上呼吸道感染、尿路感染和关节痛。3%的患者发生严重感染。在 4 项已发表的培塞利珠单抗治疗 CD 的对照试验中，与其他 TNF-α拮抗剂的研究一样，存在类似的局限性，包括高安慰剂反应、疾病自然波动、以及使用克罗恩病活动指数来评估结果。然而，培塞利珠单抗对常规治疗反应不佳的中重度 CD 成人患者是一种有效的药物。目前尚无长期疗效和安全性数据。培塞利珠单抗和阿达木单抗与英夫利昔单抗不同，可自行给药。
由于成本相似，且缺乏头对头比较，患者和医生的偏好可能决定 TNF-α拮抗剂的选择。
