美国FDA已批准比利时UCB制药公司克隆氏病（Crohn's disease）治疗新药Cimzia，获准依据为1500名受试者参加的一系列临床实验中获取的安全性及疗效数据，但FDA同时警告这种药物可导致严重的不良反应。至此，Cimzia可用于那些对常规疗法无应答的中-重度克隆氏病患者。   Cimzia可以显著缓解克隆氏病症状，但患者用药时需要对其进行严密监测，因为它可引发严重不良反应，其中包括需住院治疗甚至致死的感染，因为该药会影响免疫系统，降低人体对传染性疾病（如肺结核）的抵抗力。此外，作为一种肿瘤坏死因子(TNF)拮抗剂，Cimzia还可能导致淋巴瘤或其他恶性肿瘤，但临床实验结果未显示该药会增加罹患肿瘤的风险。基于上述情况，FDA要求UCB进行Cimzia售后实验，并获取该药的长期性安全数据。   Cimzia将进入市场，与雅培公司同类产品Humira (adalimumab)进行竞争，后者于一年前获得FDA的批准，副作用与Cimzia类似。  Cimzia approved for rheumatoid arthritis The FDA has approved Cimzia injection (certolizumab pegol, from UCB), a pegylated anti-tumor necrosis factor (TNF), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). This approval was based on UCB's comprehensive clinical program, including data from four Phase III, multi-center, placebo-controlled studies, involving more than 2,300 patients with RA and over 4,000 patient-years experience. Cimzia was evaluated as monotherapy or in combination with methotrexate. Patients treated with Cimzia alone experienced significant improvements in signs and symptoms, as well as physical function and pain. Patients treated with Cimzia together with methotrexate experienced significant improvements in signs and symptoms, physical function, and pain as early as week one, and sustained at week 24 and for up to one year. Cimzia will now also be available in a prefilled syringe, in addition to the single dose vials of lyophilized powder for subcutaneous injection after reconstitution, which is already on the market. Cimzia is already indicated 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. http://www.empr.com/cimzia-approved-for-rheumatoid-arthritis/article/136790/