ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has issued a public health advisory concerning 3 confirmed, and 1 possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab).
Three of those patients have died. All 4 patients were treated with the drug for more than 3 years. None of the patients wase receiving other treatments that suppress the immune system.
The FDA is reviewing this latest information. The agency will take appropriate steps to ensure:
- the risks of Raptiva do not outweigh its benefits;
- patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
- health care professionals carefully monitor patients for the possible development of PML.
PML is caused by a virus that affects the central nervous system. It usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking, and personality changes. There is no known effective prevention or treatment.
Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including 4 other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.
In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy to include a medication guide to educate patients about the drug's risks.
The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease. The FDA also urges medical professionals to periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their doctors immediately if they experience any such symptoms.
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole-body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation, which results in the red, inflamed, and scaly patches of skin associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system, which increases a patient's susceptibility to infections.
Health care professionals and consumers may report serious adverse events or quality problems with this product to the FDA's MedWatch Adverse Event Reporting program online or by regular mail, fax, or phone.
- Online: Go to www.fda.gov/MedWatch/report.htm.
- Regular Mail: Use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm, and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
- Fax: Send to (800) FDA-0178.
- Phone: Call (800) FDA-1088.
圣路易斯（MD Consult）——美国食品与药物管理局（FDA）针对Raptiva（efalizumab，依法利珠单抗）所致进行性多灶性白质脑病（PML，一种罕见的脑部感染性疾病）病例报告（3例确诊和1例疑似）发布了一项公众健康忠告。
上述患者中3例已经死亡。所有4例患者均接受Raptiva治疗超过3年。这些患者都没有接受其他免疫抑制治疗。
FDA正在对上述最新信息进行分析，旨在采取适当措施以确保：
• Raptiva的危险没有超出其益处；
• 向接受Raptiva治疗的患者明确地告知PML的症状和体征；
• 医护人员对可能发生的PML进行密切监测。
PML由一种感染中枢神经系统的病毒引起，通常发生于免疫系统严重受损的人群，可导致不可逆的神经功能下降和死亡。PML的症状可包括极度虚弱、协调性丧失、视力改变、说话困难和性格改变。目前还没有有效的预防及治疗措施。
银屑病是一种慢性病，目前已有许多有效的治疗选择，包括除Raptiva之外的另外4种获批的生物制剂、紫外光疗法以及环孢素、阿维A和甲氨蝶呤等药物。一般来说，银屑病治疗常以数种疗法交替进行。
2008年10月，Raptiva的产品标签被修改，修改后的标签在黑框警告中强调“Raptiva具有导致PML等危及生命感染的危险”。同时，FDA指导该药的生产厂家Genentech公司制定“风险评估和减缓策略”，在用药指南中向患者告知该药物的潜在危险。
FDA强烈建议，医护人员应密切监测接受Raptiva治疗的患者和已停止该治疗的患者的神经系统疾病症状及体征。FDA还要求医生定期对持续治疗的益处进行再评估。患者应知晓PML症状，一旦出现任何此类症状，应立即与其经治医师联系。
Raptiva获准用于治疗适宜接受系统性（全身）治疗或光疗的中至重度斑块型银屑病成人患者，一周注射一次。该药物的作用机制是抑制免疫系统中的T细胞（抗感染血细胞）。当这些细胞被激活时，它们可迁移至皮肤并引发炎症，造成银屑病红色、炎性和鳞状的皮肤斑块。Raptiva对T细胞的抑制可引起免疫系统功能下降，从而增加了患者对感染的易感性。
医护人员和消费者可将有关该药的严重不良反应事件或质量问题通过在线方式或普通信件、传真和电话方式上报至FDA的MedWatch不良事件报告系统，具体方法如下：在线，请登陆www.fda.gov/MedWatch/report.htm；信件，从网址www.fda.gov/MedWatch/getforms.htm下载已预付邮资的FDA 3500表，填写完毕后寄至MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787；传真，800-FDA-0178；电话，800-FDA-1088。
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