FDA批准PDE-4抑制剂用于治疗银屑病关节炎

美国食品药品管理局(FDA)3月21日宣布，基于针对1,493例患者的3项研究结果，口服磷酸二酯酶-4抑制剂apremilast已获准用于成年活动性银屑病关节炎治疗。

据 FDA声明，作为上市后要求，生产商将通过一项妊娠注册研究评估该药物对妊娠女性的暴露效应。

FDA称，在3项研究中，与安慰剂组患者相比，apremilast治疗患者银屑病关节炎体征和症状得到改善。与治疗相关的最常见不良事件为腹泻、恶心和头痛。apremilast治疗患者报告出现抑郁也更为频繁。

Ⅲ期研究结果已于2013年在美国风湿病学会(ACR)年会和欧洲风湿病学年会上报告。

FDA声明指出，治疗期间，建议医疗专业人员定期监测患者体重，“一旦出现不明原因或具有临床意义的体重下降，应评估体重下降并考虑停止用药”。新基医药公司(Celgene Corporation)将以商品名Otezla销售apremilast。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

Apremilast, an oral phosphodiesterase-4 inhibitor, has been approved for treating adults with active psoriatic arthritis, based on the results of three studies of 1,493 patients, the Food and Drug Administration announced on March 21.

As a postmarketing requirement, the manufacturer will evaluate the effects of exposure to treatment in pregnant women with a pregnancy registry, according to an FDA statement.

In the three studies, the signs and symptoms of psoriatic arthritis improved among patients treated with apremilast, compared with those on placebo. Diarrhea, nausea, and headache were the most common adverse events associated with treatment. Depression was reported more frequently among those treated with apremilast in the studies, according to the FDA.

Results of the phase III studies were reported in 2013 at the American College of Rheumatology annual meeting and at the annual European Congress of Rheumatology.

During treatment, health care professionals are advised to regularly monitor the weight of patients, and "if unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered," the statement said. Celgene Corporation will market apremilast under the brand name Otezla.