Xeljanz获准用于治疗某些RA患者

圣路易斯(MD Consult)-2012年11月6日，美国食品药品管理局(FDA)和辉瑞公司联合宣布，Xeljanz(枸橼酸托法替尼)获准用于对氨甲喋呤治疗应答不充分或不耐受的中至重度活动性类风湿关节炎(RA)成人患者。Xeljanz是一种Janus激酶抑制剂。

Xeljanz可作为单一治疗或与氨甲喋呤或其他非生物疾病缓解性抗风湿药物(DMARD)联合使用。该药不应与生物性DMARD或强免疫抑制剂(如硫唑嘌呤和环孢菌素)联合使用。经核准的Xeljanz剂量为每日2次，每次5 mg。

7项临床试验在中至重度活动性RA成人患者中评估了Xeljanz的安全性和有效性。在所有试验中，与接受安慰剂治疗的患者相比，接受Xeljanz治疗的患者均具有临床应答和身体功能上的显著改善。

临床试验中，最常见的不良反应为上呼吸道感染、头痛、腹泻、鼻充血、咽喉痛和鼻咽炎。

使用Xeljanz与严重感染风险增高相关，包括机会性感染、结核、癌症和淋巴瘤。Xeljanz产品标签中附有关于这些安全性风险的加框警告。Xeljanz治疗还与胆固醇和肝酶数值增高及血细胞计数降低相关。

为了研究Xeljanz对心脏病、癌症和严重感染的长期影响，FDA要求进行一项上市后研究，该研究将对两种剂量的Xeljanz治疗进行评估，并纳入一个接受另一种经核准治疗的患者组作为对照。

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ST LOUIS (MD Consult) - On November 6, 2012, the US Food and Drug Administration (FDA) and Pfizer announced the approval of Xeljanz (tofacitinib citrate) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have shown an inadequate response or intolerance to methotrexate. Xeljanz is a Janus kinase inhibitor.

Xeljanz may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). It should not be used in combination with biologic DMARDs or potent immunosuppressives, such as azathioprine and cyclosporine. The approved dose of Xeljanz is 5 mg twice daily.

The safety and effectiveness of Xeljanz were evaluated in 7 clinical trials in adult patients with moderately to severely active RA. In all of the trials, patients treated with Xeljanz experienced improvement in clinical response and physical functioning compared with patients treated with placebo.

The most common adverse reactions in clinical trials were upper respiratory tract infections, headache, diarrhea, nasal congestion, sore throat, and nasopharyngitis.

The use of Xeljanz was associated with an increased risk of serious infections, including opportunistic infections, tuberculosis, cancers, and lymphoma. The Xeljanz Label carries a Boxed Warning regarding these safety risks. Xeljanz treatment is also associated with increases in cholesterol and liver enzyme values and decreases in blood counts.

To study the long-term effects of Xeljanz on heart disease, cancer, and serious infections, the FDA is requiring a postmarketing study that will evaluate 2 doses of Xeljanz and include a group of patients on another approved treatment to serve as a comparison.