欧洲药物管理局建议欧盟允许Olumiant上市用于治疗成人中度或重度类风湿性关节炎，主治患者对于所用药物没有充分的敏感性和集结多种疾病于一身的缓解抗风湿药物。口服Olumiant可以和甲氨蝶呤同用治疗疾病。

　　类风湿性关节炎是一种免疫系统疾病，可以引起炎症和关节损伤。在欧盟有0.5~1%的人们忍受着类风湿疾病的困扰。中度类风湿性关节炎患者饱受慢性炎症困扰的同时还忍受着疼痛和关节僵直的困扰，这些症状是可以减轻的，但是类风湿性关节炎引发的残疾却是不能够被治愈的。

　　这些抗风湿的药物常和甲氨蝶呤联合使用或常常单独注射使用。然而即使很多用药后的效果是显著的，但是反馈效果并不能令人满意。因此，新的治疗方法还需要更多的实验和尝试。

　　Olumiant能够阻断酪氨酸蛋白激酶，酪氨酸蛋白激酶是免疫系统重要酶之一，参与类风湿性关节炎中炎症的发生。通过阻断此酶，Olumiant能够减缓炎症并且减少其他疾病发生。

　　Olumiant在临床上最常见的副作用是是病患血脂升高和上呼吸道感染引发恶心。

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　　The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for Olumiant (baricitinib) for the treatment of adults with moderate to severe active rheumatoid arthritis. It is to be used to treat patients who have not responded adequately to, or who are unable to tolerate one or more disease?modifying anti-rheumatic drugs (DMARDs). Olumiant, which is taken by mouth, can be used on its own or in combination with methotrexate.

　　Rheumatoid arthritis is an immune system disease causing inflammation and damage in the joints. It affects between 0.5% and 1% of people in the EU. Patients with moderate to severe rheumatoid arthritis have chronic inflammation causing fatigue, pain and joint stiffness. While the symptoms are reversible with appropriate treatment, joint damage and the associated disability are permanent.

　　Patients with rheumatoid arthritis are treated with medicines called DMARDs, most commonly the oral treatment methotrexate on its own, or in combination with another DMARD which is given by injection or infusion. However, even with the most effective treatments available, more than half of patients do not achieve a satisfactory response. Therefore, new treatment options are needed.

　　Olumiant works by blocking the action of enzymes known as Janus kinases (JAKs). These enzymes play an important role in the process of immunity and inflammation that occurs in rheumatoid arthritis. By blocking these enzymes, Olumiant is expected to reduce the inflammation and other symptoms of the disease. It would be first JAK inhibitor to be used in the treatment of rheumatoid arthritis in the EU and offers a different mode of action to what is currently available.

　　The recommendation from EMA’s Committee for Medicinal Products for Human Use(CHMP) is based on results of four randomised controlled trials in 3,100 adults with moderate to severe active rheumatoid arthritis. One trial compared Olumiant to methotrexate, another compared Olumiant to adalimumab, and two compared Olumiant to placebo. Overall, Olumiant was more effective at reducing disease activity in patients with moderate to severe rheumatoid arthritis, compared to those treated with methotrexate and adalimumab.

　　Maintenance of efficacy was demonstrated in 52-week-long trials. Olumiant showedefficacy in patients who had not responded to biologic DMARDs as well as in patients that had never been treated before.

　　The most common side effects with Olumiant in clinical trials were increased lipid (fat) levels in the blood, upper respiratory tract infections and nausea.

　　The opinion adopted by the CHMP at its December 2016 meeting is an intermediary step on Olumiant’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, a decision on price and reimbursement will then take place at the level of each Member State considering the potential role/use of the medicine in the context of the national health system of that country.