Xeljanz Approved for Rheumatoid Arthritis
Pfizer announced that the FDA has approved Xeljanz (tofacitinib citrate) tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had inadequate response or intolerance to methotrexate. Xeljanz may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDS).
Results from clinical trials showed that Xeljanz demonstrate consistent efficacy across a broad range of clinical measures and patient types, including patients who inadequately responded to non-biologic DMARDs and anti-TNF agents, and it has a safety profile that is well-characterized to date.
Xeljanz inhibits the Janus kinase (JAK) pathway, a signaling pathway inside the cell that plays an important role in the inflammation involved in RA. Xeljanz was approved as a second-line treatment for RA, which means treatment with a biologic is not required before taking Xeljanz.
The FDA has approved Xeljanz 5mg with a Risk Evaluation and Mitigation Strategy (REMS) designed to inform healthcare providers and patients about the serious risks associated with treatment. The FDA stated that further data are required to assess the benefit-to-risk profile of the 10mg dose.
Xeljanz is expected to be available towards the end of November.
Xeljanz批准用于治疗类风湿关节炎
2012年11月6日,美国FDA批准Xeljanz(tofacitinib,托法替尼)治疗对氨甲喋呤(methotrexate)无足够应答或不能耐受的成人中度至重度活动性类风湿关节炎。
类风湿性关节炎是一种自身免疫性疾病,患者体内的免疫系统错误地攻击健康组织,导致关节及周围组织炎症。据美国疾病控制和预防中心报告,在美国估计有150万人受类风湿性关节炎影响。Xeljanz每日两次,每次2粒,它通过阻断所谓的“Janus激酶”奏效,后者在类风湿关节炎的关节炎症起重要作用。
FDA原先计划在11月21日作出Xeljanz审批决定。Xeljanz为氨甲喋呤无效的类风湿关节炎患者提供了一种新的治疗选择。
在中度至重度活动性类风湿关节炎患者参与的7项临床试验中对Xeljanz的安全性和效果进行了评估。在所有这些试验中,以Xeljanz治疗的患者相比安慰剂组临床应答和和身体功能均有改善。
使用Xeljanz与严重感染,包括机会性感染(主要是在免疫系统受到抑制时出现感染)、结核、肿瘤和淋巴瘤的风险增加有牵连。Xeljanz标签有一加框警示语,提示上述安全性信息。Xeljanz还与胆固醇和肝酶测试指标升高和血细胞计数减少相关。
FDA批准Xeljanz时附带一项风险评估和消减计划(REMS),包括用药指南和安全性信息,以及与医务人员的沟通计划,告知他们与Xeljanz有关的严重风险。
为了研究Xeljanz对心脏疾病、癌症和严重感染的长期影响,FDA要求开展一项上市后研究,对两种剂量Xeljanz进行评估,并且包括一组以别的经获准药物患者作为对照。
在临床试验中,最常见的不良反应为上呼吸道感染、头痛、腹泻、鼻腔和上咽部炎症。