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。
Pharmaceutical firm teams with consumer product company to offer new option. UCB and OXO are offering arthritis patients a new syringe built specifically for the challenges rheumatoid arthritis (RA) patients face when self-administrating their medicine. UCB's Cimzia -- recently approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderately to severely active RA -- comes in the new prefilled syringe, which comes with the Arthritis Foundation's Ease-of-Use Commendation. In public statements, company spokespeople have emphasized the importance of designing a syringe and packaging components that take into account the dexterity challenges RA patients face -- even accounting for different grip styles and strengths. "This syringe, a result of our partnership with OXO, demonstrates UCB's commitment to patients with severe diseases," said Roch Doliveux, UCB's CEO in a press release. "I am proud of the fact that people living with rheumatoid arthritis worked directly with the design and engineering teams to develop this syringe. "We have designed a syringe that that takes into account some of the challenges that come with self-injection ... [and] our long-term partnership with OXO will allow us to help make everyday living easier for rheumatoid arthritis patients." UCB and OXO brought in patients to assess the syringes available in the market place and the UCB prototype. This led to the redesign of many aspects of the syringe and its packaging. According to the press release, Cimzia's prefilled syringe is designed with the following in mind:
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Cimzia(certolizumab pegol)用于治疗类风湿性关节炎简介:
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。
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