部分中文赛妥珠单抗处方资料（仅供参考）
UCB公司的单克隆抗体Cimzia对克罗恩病有疗效
根据初步临床研究的结果,由优时比(UCB)公司研制的一种单隆抗体——Cimzia(certolizumab pegol,赛妥珠单抗)可以减轻采用常规治疗不能完全缓解病情的成年中、重度克罗恩病(Crohn′s disease,又称局限性回肠炎、局限性肠炎、节段性肠炎和肉芽肿性肠炎)活动期病人的临床症状,而且该药对于那些不能耐受英利昔单抗(infliximab, Centocor公司的产品,商品名为Remicade)或使用英利昔单抗无效的病人也有一定疗效。
Cimzia与英利昔单抗和雅培(Abbott)公司的阿达木单抗(adalimumab,商品名为Humira)一样,也是一种肿瘤坏死因子(TNF)抑制剂,可缓解克罗恩病症状。目前用于治疗克罗恩病的生物制剂常会在病人使用一段时间后失效,无法阻止病情的发展,而且病人还会对这些特殊的生物制剂产生免疫介导反应。因而此时医生通常需使用一系列的药物,并且在几种药物之间不断地进行更换。
此次名为“Welcome研究”的临床试验对象为539名曾对英利昔单抗产生应答、但现已不再产生应答或是因为急性或迟发性输液反应而对其不能耐受的病人,研究分为两期:一是开标记诱导期,即在试验开始、2周和4周时分别给予赛妥珠单抗400mg；然后是双盲维持期,即连续6～24周使用赛妥珠单抗400mg。试验的首个终点指标为:用药第6周时,病人的克罗恩病活动指数(Crohn′s disease activity index, CDAI)至少降低至100,若降低至150则可视为症状缓解。初步研究结果显示,用药6周后,有62.2%的病人对赛妥珠单抗产生了应答, 39.3%的病人症状减轻;而在用药第2周,产生应答的病人比例即达到33.2%,在第4周时,有43.8%的病人产生了应答。这一结果与另一项名为“Precise 2 试验”的结果(病人应答率为64%)相近。由于参加Precise 2试验的病人在使用赛妥珠单抗前并未使用过英利昔单抗,故这两项研究的结果提示,赛妥珠单抗对使用过英利昔单抗的病人仍有较好疗效。
cimzia（赛妥珠单抗，CERTOLIZUMAB PEGOL）类风湿新药
比利时UCB公司宣布，已收到美国FDA关于新药Cimzia（certolizumab pegol）的生物制剂新药上市申请的回复函。该药为第一个用聚乙二醇修饰的抗肿瘤坏死因子药物，用于治疗类风湿性关节炎。
作为批准Cimzia上市的前提条件，FDA要求UCB公司提供更新的、可靠的临床研究资料，包括从申请生物制剂上市许可以来的最新数据。
UCB公司表示，Cimzia可适用于中到重度类风湿性关节炎患者及其他炎性疾病，UCB公司一定会尽力达到FDA的要求。2008年2月，UCB公司向FDA递交该药治疗类风湿性关节炎的生物制剂上市申请之前，已进行了包含超过2300名受试者的多中心对照Ⅲ期临床试验。
2008年4月，美国FDA已批准Cimzia用于治疗对传统治疗方法不敏感的克罗恩病中到重度患者。其治疗克罗恩病的效果在瑞士也得到了认可。目前，欧洲EMEA正在对Cimzia治疗类风湿性关节炎的效用进行积极审查
此药需冷藏。
Cimzia: new TNF-alpha inhibitor
01 December 2009, 3:29pmCimzia is a new addition to the management of moderate to severely active rheumatoid arthritis in combination with methotrexate or as monotherapy.
PHARMACOLOGY
Certolizumab pegol is a PEGylated formulation of a humanized monoclonal antibody specific for tnf-α.
CLINICAL STUDIES
In two studies comparing the use of certolizumab and MTX to placebo and MTX, significantly more patients in the certolizumab groups achieved the American College of Rheumatology 20 per cent criteria for improvement (ACR20) at 24 weeks.1,2The most common adverse effects in the trials were headache, hypertension, UTI, URTI and back pain.1,2

Manufacturer:
UCB, Inc.
Pharmacological Class:
Tumor necrosis factor (TNF) blocker
Active Ingredient(s):
Certolizumab pegol 200mg/vial; pwd for SC inj after reconstitution;
preservative-free.
Indication(s):
In moderately to severely active Crohn's disease: to reduce signs and symptoms and to maintain clinical response in adult patients with inadequate response to conventional therapy.
Pharmacology:
Elevated levels of TNFα have been implicated in the pathology of Crohn's disease. Certolizumab pegol is a recombinant, humanized antibody Fab' fragment that has an affinity for human TNFα, a proinflammatory cytokine that plays a key role in the inflammatory process. TNFα stimulates the production of interleukin-1, prostaglandins, platelet activating factor, and nitric oxide. After treatment with certolizumab pegol, patients with Crohn's disease had a decrease in C-reactive protein.
Clinical Trials:
Two placebo-controlled trials were conducted in patients with moderately to severely active Crohn's disease. In the first study, 662 patients were given either certolizumab pegol 400mg or placebo at weeks 0, 2, 4, and then every 4 weeks to week 24. At week 6, the proportion of clinical responders in patients on the study drug was 35%, compared to 27% for placebo; clinical remission was noted in 22% of patients given the study drug versus 17% for those given placebo. The difference in the proportion of patients who were in clinical response at weeks 6 and 26 was also significant (23% vs. 16%), indicating a maintenance of clinical response.
Legal Classification:
Rx
Adults:
Give by SC inj in abdomen or thigh. 400mg (two 200mg inj) on day 1, then at weeks 2 and 4; maintenance 400mg every 4 weeks.
Children:
Not recommended.
      
Precaution(s):
Active infections: not recommended. Chronic or history of recurring infections. Conditions that predispose to infection. Test for tuberculosis, treat TB first. Monitor closely for new infections, discontinue if serious infection develops. History of TB or histoplasmosis exposure. Immunosuppressed. Hepatitis B infection; discontinue if reactivation occurs. Malignancies. CNS demyelinating disorders.
Hematological abnormalities. CHF. Discontinue if lupus-like syndrome or serious hypersensitivity reaction occurs. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interaction(s):
Concurrent anakinra, live vaccines or other TNF blockers: not recommended.
Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPPT).
Adverse Reaction(s):
Upper respiratory infections, UTI, arthralgia, other infections; rare: TB, HBV reactivation, hypersensitivity reactions, malignancies, antibody formation.

How Supplied:
Kit—1 (2 single-dose vials w. syringes, needles, supplies)

Last Updated:
1/15/2009

附件：

201142500190225.pdf

-----------------------------------------------------
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
-----------------------------------------------------
产地国家: 美国
原产地英文商品名:
CIMZIA STARTER KIT 200MG/ML/SYRINGE/KIT
原产地英文药品名:
CERTOLIZUMAB PEGOL
中文参考商品译名:
CIMZIA起始套装 200毫克/毫升/注射器/套
中文参考药品译名:
赛妥珠单抗
生产厂家中文参考译名:
UCB INC
生产厂家英文名:
UCB INC

-----------------------------------------------------
产地国家: 美国
原产地英文商品名:
CIMZIA 200MG/ML/FILLED SYRINGE 2SYRINGES/KIT
原产地英文药品名:
CERTOLIZUMAB PEGOL
中文参考商品译名:
CIMZIA 200毫克/毫升/填充注射器 2注射器/套
中文参考药品译名:
赛妥珠单抗
生产厂家中文参考译名:
UCB INC
生产厂家英文名:
UCB INC