依那西普 英文名：Etanercept；商品名：Enbrel（恩利）                          
依那西普是一种人源TNF-α受体抗体融合蛋白，可溶性抗肿瘤坏死因子融合蛋白，是肿瘤坏死因子(TNF-α)拮抗剂，通过抑制TNF-α可以起到控制炎症、阻断病情进展的作用，它属DMARD类药物，是抗风湿病的生物制剂；用于活动性类风湿关节炎，牛皮癣及关节性牛皮癣，幼年特发性关节炎，活动性强直性脊柱炎。
通用名为注射用重组人II型TNF-α受体抗体融合蛋白。该药于1998年经美国FDA批准用于治疗类风湿性关节炎，2002年批准用于治疗银屑病性关节炎，2004年批准用于治疗寻常性银屑病。
【适应证】
用于活动性类风湿关节炎，银屑病及银屑病关节炎，幼年特发性关节炎，活动性强直性脊柱炎。
【注意事项】
(1)本品有诱发感染，患者有反复发作的感染史，尤其是老年者，使用本品时应慎重。
(2)在使用过程中患者出现感染，应及时停药并密切观察。
(3)在使用过程中，应注意过敏反应的发生，包括血管性水肿、荨麻疹以及其他严重反应，根据其情况给予抗过敏药物或停药。
(4)使用本品期间不可接种活疫苗。
(5)本品曾导致充血性心力衰竭的病人病情恶化，因此，重度心衰患者不宜使用本品。
(6)治疗前要接受结核感染筛查(皮肤试验、胸透)，对有结核感染或感染可疑者应首先抗结核治疗3个月，再考虑用本品治疗。
(7)治疗前要筛查乙型及丙型病毒感染，有活动性者不宜应用本品。
(8)在治疗类风湿关节炎时宜与甲氨蝶呤联合应用以提高疗效。
【禁忌证】
感染、活动性结核病患者、对本品或制剂中成分过敏者
禁用。孕妇及哺乳期妇女禁用。
【不良反应】
常见注射部位局部反应，包括轻至中度红斑、瘙痒、疼痛和肿胀等，注射部位反应通常发生在开始治疗的第一个月内，在随后的治疗中发生频率降低。注射部位反应平均持续3～5天。在临床试验中出现的其他不良反应包括头痛、眩晕、皮疹、咳嗽、腹痛、白细胞计数减少、中性粒细胞减少、鼻炎、发热、关节酸痛、肌肉酸痛、困倦、面部肿胀、面部过敏、肝功能异常、肾结石、肺纤维化等。
【用法与用量】
皮下注射：成人推荐剂量：一次25mg，一周2次，注射部位可为大腿、腹部和上臂。儿童推荐剂量：一周400μg/kg，最大剂量为50mg，分次皮下注射。

Pfizer Japan and Takeda Launch "Enbrel® Subcutaneous Injection 50mg Pen 1.0mL", New Method of Administration for Rheumatoid Arthritis Treatment Enbrel®
-Patients benefit from easy one-click administration-
Pfizer Japan Inc. (Head office: Shibuya-ku, Tokyo; “Pfizer”) and Takeda Pharmaceutical Company Limited (Head office: Chuo-ku, Osaka; “Takeda”) jointly announced that both parties launch on June 10, 2013 Enbrel® Subcutaneous Injection 50mg Pen 1.0mL, a new method of administration for the rheumatoid arthritis medicine Enbrel (etanercept) which is being co-promoted by both parties. The drug obtained regulatory approval from the Ministry of Health, Labour and Welfare on March 22, 2013 and its NHI (National Health Insurance) price for reimbursement was list on May 31, 2013.
Enbrel Subcutaneous Injection 50mg Pen 1.0mL is an autoinjector pen pre-filled preparation with the same composition as the conventional Enbrel® Subcutaneous Injection 50mg Syringe 1.0mL, and it is expected to offer the following benefits for patient population.
Easy administration by clicking on a button on the top of the pen
Concealing the injection needle in the pen body to alleviate the discomfort of patients who prefer not to see the needle during injection
Design that reduces the risk of accidental pricking – and infection – following administration.
Easier to use than its syringe equivalent, possibly reducing patients’ burden and the time and effort spent by medical institutions training patients in its use.
"We are delighted to be able to provide an easy-to-use treatment option to rheumatoid arthritis patients with pain and swelling in their joints,” said Mark Swindell, Regional President Asia-Pacific, Specialty Care, Japan Business Unit Head. “Enbrel is the biological preparation that has the longest history of usage in rheumatoid arthritis treatment　in the world. We hope that the introduction of autoinjector pen will be an opportunity to provide a better treatment option to patients who have been reluctant to self-administer."
“Conventional vial form of Enbrel was launched in March 2005 in Japan, followed by syringe preparations in June 2008, we are now able to start providing pen preparations which offer better convenience for patients,” said Masato Iwasaki, Ph.D., Senior Vice President, Pharmaceutical Marketing Division of Takeda. “Since rheumatoid arthritis requires long-term treatment, it is important to continue treatment while mitigating mental and physical burdens on patients. The 50mg autoinjector pen enables quick and safe administration with one click, making self-injection easier. We are excited to offer this new treatment option to an even greater number of rheumatoid patients.”
Enbrel® Subcutaneous Injection 50mg Pen 1.0mL
■Overview of Enbrel® Subcutaneous Injection 50mg Pen 1.0mL
Product name Enbrel® Subcutaneous Injection 50mg Pen 1.0mL
Nonproprietary name Etanercept (rDNA)
Indications and Usage For those who have had an inadequate response to existing therapies for rheumatoid arthritis
(including prevention of structural damage to joints)
Administration / dose For adults, 10-25mg etanercept (rDNA) once a day, twice a week, or 25-50mg once a day, once a week administered by means of subcutaneous injection.
Precautions related to Dosage and Administration: (excerpt)
Objective patients for Enbrel 50 mg Pen for subcutaneous injection are limited to the patients who are administered the drug of 50 mg as recommended dosage.  Full dosage of Enbrel 50 mg Pen 1.0 mL should be used at one time.
Date of regulatory approval March 22, 2013
Date of NHI price listing May 31, 2013
Launch date June 10, 2013
 50mg 1mL per kit)
■About EnbrelEnbrel is a biological drug that has been approved for the treatment of rheumatoid arthritis patients for who did not respond adequately to existing therapies. The drug suppresses rheumatoid arthritis inflammation by binding to and inactivating tumor necrosis factor (TNF), a cytokine1) which plays an important role in the mechanism of rheumatoid arthritis inflammation, and also by binding to lymphotoxin alpha (LT alpha), another cytokine that affects the condition of rheumatoid arthritis. Enbrel is the only TNF alpha receptor preparation which is believed to have less concern about reduced efficacy due to the neutralizing antibodies generated.
1) Cytokine is a collective term for protein factors that mediate mutual effects between cells. It plays an important role in immunity, inflammation and biological defense.

什么是恩利 （注射用依那西普）
恩利（注射用依那西普）是一种TNF-抑制剂，适用于类风湿关节炎(RA)和强直性脊柱炎(AS)。它直接作用于类风湿性疾病的关键致病因子——肿瘤坏死因子TNF，从根本上阻断类风湿关节炎和强直性脊柱炎的疾病进程。
作为全球首个类风湿性疾病生物治疗药物，恩利（注射用依那西普）在2008年全球处方药市场畅销药物中排名第五位，在生物制剂中排名第一，自1998年获得美国FDA批准以来，已在全球80多个国家上市，并有超过200万患者年的使用经验，是目前使用经验最多、临床数据最全面的类风湿关节炎和强直性脊柱炎生物治疗药物并已经获得SFDA批准在中国上市。
恩利（注射用依那西普）的特点和优势
恩利（注射用依那西普）用法简单方便，应用过程中因不产生中和性抗体而无需增加剂量，可长期维持高效的血药浓度；其半衰期为70小时左右，从体内较快清除，维护患者用药安全。
恩利（注射用依那西普）是首个原研的全人源化可溶性TNF受体抑制剂，可以抑制TNF的生物活性，从而阻断类风湿关节炎和强直性脊柱炎的疾病进程。
历经17年临床验证，恩利 （注射用依那西普）是类风湿性关节炎和强直性脊柱炎患者的信心之选。
恩利（注射用依那西普）早期应用可帮助更多的RA患者实现“三重缓解”（关节结构缓解、躯体功能缓解、临床症状缓解），长期使用的患者恶性肿瘤或淋巴瘤的发生率低。恩利（注射用依那西普）还可全面控制强直性脊柱炎各种症状，长期使用安全性好，患者葡萄膜炎及肺结核发生率低。
恩利 （注射用依那西普）获奖情况
2001年以鼓励最优秀的美国发明者为宗旨，知识产权拥有者组织授予恩利 （注射用依那西普）的发明者 “2001年年度发明大奖”以奖励他们富有创造力的天才及他们对于提高类风湿性关节炎患者生活质量的贡献。此奖项是美国历史最悠久且最知名的发明者大奖。
2002年恩利 （注射用依那西普）获得被誉为医学界“诺贝尔奖”的Prix Galien加拿大创新医药产品大奖。
恩利（注射用依那西普）临床试验
成人类风湿关节炎
一项MTX单药治疗与MTX联合依那西普治疗对早期活动性中重度RA治疗效果比较（COMET）研究结果显示90%的患者关节结构缓解（第2年，校正后sharp总评分*变化≤0.5），62%的患者躯体功能缓解（第2年，校正后HAQ**≤0.5），57%的患者临床症状缓解（第2年，校正后DAS28#≤0.5）。
强直性脊柱炎
在3项随机、双盲的研究中评价了依那西普治疗强直性脊柱炎的疗效，给药方案为每周2次给予25mg依那西普或安慰剂，试验总共入组401例患者，其中203例给予依那西普治疗。
结果显示恩利（注射用依那西普）可全面控制强直性脊柱炎各种症状，显著提高ASAS20#(强直性脊柱炎评估指标4项中至少3项的改善≥20%)改善率。在接受依那西普治疗的强直性脊柱炎患者在第一次访视时（第2周）即出现显著的临床疗效，并在6个月的治疗期间一直保持不变。