在积极的治疗类风湿性关节炎Masitinib:结果的多中心、非盲、dose-ranging,第二阶段的研究。

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Tebib J, Mariette X,资产阶级P, Flipo RM,发言P, Le和X, Gineste P L,曼斯菲尔德CD, Moussy, Dubreuil P, Hermine O, Sibilia J

在积极的治疗类风湿性关节炎Masitinib:结果的多中心、非盲、dose-ranging,第二阶段的研究。

关节炎Res其他。2009;11 (3):R95。doi: 10.1186 / ar2740。Epub 2009年6月23日。

PubMed ID

19549290 (在PubMed

]

文摘

简介:从目前的治疗方案从活跃的类风湿性关节炎(RA)患者仍然不足,特别是那些对疾病修饰治疗风湿病的药物(DMARDs),新的和改进的药物治疗是必要的。本研究评估的安全性和有效性masitinib (AB1010),一个强有力的和选择性的c - kit蛋白酪氨酸激酶抑制剂,DMARD-refractory RA的单一疗法治疗。方法:这是一个多中心、不受控制的、非盲、随机dose-ranging,第二阶段试验》。Masitinib 43是口服药物患者应对DMARDs不足,在初始随机剂量水平的3和6毫克/公斤/天在12周的时间内。剂量调整允许基于耐受性和响应标准。疗效评估通过美国风湿病学院提高20% / 50% / 70%的标准(ACR20/50/70)反应,疾病活动分数使用28联合计数(DAS28),改善RA指数(ACRn)和c反应蛋白(CRP)改进,相对于基线在12周。观察结果:改善疗效端点,包括ACR20/50/70分数为54%,26%和8%,分别和降低CRP水平大于50%的大约一半的人口。这个进步是可持续的在一个扩展阶段(> 84周),也独立于初始DMARD耐(抗肿瘤坏死因子-α和/或甲氨蝶呤)。病人提取率相对较高(37%)需要使用最后观察结转(LOCF)数据归责。不良事件的发生率高(95%),尽管大多数是轻度或中度的相当大的频率下降治疗12周后观察。 Two nonfatal serious adverse events were reported. Dose-response analyses tentatively indicate that an initial dosing level of 6.0 mg/kg per day administered orally in two daily intakes is the most appropriate, based upon potency and tolerability trends. CONCLUSIONS: Treatment with masitinib improved DMARD-refractory active RA. Following an initial high incidence of mostly mild to moderate side effects during the first 12 weeks of treatment, masitinib appears to be generally well tolerated. This, together with evidence of a sustainable efficacy response, suggests that masitinib is suitable for long-term treatment regimens. Since this was the first study of masitinib in a nononcologic pathology, the relatively high patient withdrawal rate observed can be partly attributed to a highly cautious response to adverse events. There is sufficient compelling evidence to warrant further placebo-controlled investigation. TRIAL REGISTRATION: ClinicalTrials.gov NCT00831922.

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药物

Masitinib