ST LOUIS (MD Consult) - On May 14, 2009, UCB pharmaceutical company announced that the US Food and Drug Administration (FDA) has approved Cimzia (certolizumab pegol) for the treatment of patients with moderately to severely active rheumatoid arthritis (RA). Cimzia is a pegylated anti-TNF (tumor necrosis factor) preparation.

The FDA approval of Cimzia for RA was granted on the basis of data obtained through UCB's comprehensive clinical program, including data from 4 multicenter, placebo-controlled, phase 3 trials involving more than 2300 patients with RA and over 4000 patient-years' experience. Cimzia has been studied at dosing intervals of 2 or 4 weeks and has been administered alone or together with methotrexate (MTX).

In clinical trials in which Cimzia was given in combination with MTX and compared with MTX monotherapy, patients receiving the combination experienced a significant reduction in the signs and symptoms of RA at week 24. Some study patients assigned to the combination demonstrated clinical responses within 1 to 2 weeks, compared with patients taking MTX alone. Additionally, radiographic data gathered in the study showed that patients taking Cimzia together with MTX experienced inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score at 24 and 52 weeks of treatment, compared with MTX alone (P < .001).

Evidence also exists that patients with RA treated with Cimzia as a monotherapy have experienced significant improvements in signs and symptoms, physical function, and pain.

Cimzia can be dosed at 400 mg initially and at weeks 2 and 4, followed by a dose of 200 mg every other week. For maintenance dosing, 400 mg every 4 weeks can be considered. Cimzia is available in a prefilled syringe and is administered subcutaneously. The new syringe carries the Arthritis Foundation Ease-of-Use Commendation.

圣路易斯(MD Consult)——2009年5月14日，UCB制药公司宣布，美国食品药品管理局(FDA)已批准Cimzia(certolizumab pegol)用于治疗中度至重度活动期类风湿性关节炎(RA)患者。Cimzia是一种聚乙二醇化抗肿瘤坏死因子(TNF)制剂。

FDA同意批准Cimzia用于治疗类风湿性关节炎是基于UCB公司的综合临床研究数据，其中包括来自4项多中心、安慰剂对照3期试验的数据。这些研究纳入超过2,300例类风湿性关节炎患者，涉及超过4,000病人•年的用药经验，对间隔2周或4周使用Cimzia的效果及对单用Cimzia或与甲氨蝶呤(MTX)联用的效果进行了研究。

比较Cimzia+MTX联合治疗与MTX单药治疗的临床试验显示，第24周时联合治疗组患者的类风湿性关节炎症状和体征显著减少。与MTX单药治疗组患者相比，一些联合治疗组患者在1～2周内即出现临床疗效。此外，该研究的X线检查结果显示，与MTX单药治疗组患者相比，Cimzia+MTX联合治疗组患者的关节损伤进展受到抑制，并且治疗24周和52周时修订的总Sharp评分与基线值相比变化较小，但差异具有显著性(P < 0.001)。

还有证据显示，接受Cimzia单药治疗的类风湿性关节炎患者在症状、体征、躯体功能和疼痛方面获得显著改善。

Cimzia的初始剂量为400mg，间隔2周或4周后，剂量改为200 mg，每隔1周给药1次 。维持剂量可考虑每4周400mg。已有供皮下给药的预充注射器装Cimzia上市。该新型注射器装Cimzia上附有关节炎基金会易用性认可标识。

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