Newest FDA Approvals
September 28, 2009
ST LOUIS (MD Consult) - On September 25, 2009, Centocor Ortho Biotech Inc announced that the US Food and Drug Administration has
approved Stelara (ustekinumab), a biologic product for use in adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, which then accumulate on the skin's surface and form red, scaly plaques. Stelara is a human monoclonal antibody that selectively targets the cytokines interleukin-12 and interleukin-23, proteins that contribute to the overproduction of skin cells and inflammation.
The clinical development program for Stelara included more than 2,200 patients, with 2 pivotal phase 3 trials serving as the primary basis for FDA approval. In each of these trials, a significantly higher proportion of patients receiving either Stelara 45 mg or 90 mg achieved at least a 75% reduction in psoriasis—as measured by the Psoriasis Area and Severity Index (PASI), or PASI 75—at week 12 compared with patients receiving placebo. With every-12-weeks Stelara maintenance therapy, the majority of patients achieving a PASI 75 improvement maintained substantial skin clearance for 1 year.
The administration route for Stelara is subcutaneous injection. The medication is given at weeks 0 and 4, followed by every-12-weeks dosing. The recommended starting dose of Stelara is 45 mg for patients weighing ≤220 lbs and 90 mg for patients weighing >220 lbs.
Because Stelara suppresses the immune system, the product poses a risk of infection. Serious infections have been reported in patients receiving Stelara, and some patients required hospitalization. Causitive agents included viruses, fungi, and bacteria. Patients should be screened for tuberculosis (TB) before taking Stelara and should be watched closely for signs and symptoms of TB during treatment. Moreover, patients receiving Stelara should not receive live vaccines.
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圣路易斯（MD Consult）—Centocor Ortho生物技术公司于2009年9月25日宣布美国食品药品管理局（FDA）已批准生物制剂Stelara（ustekinumab）应用于成年中至重度斑块状银屑病患者，这些患者一般行光疗或系统治疗。
银屑病是一种免疫介导的慢性疾病，由皮肤细胞增生过量所致，过量增生的细胞积聚在皮肤表面形成鳞屑性红斑。Stelara是一种人类单克隆抗体，其选择性针对细胞因子白介素-12和白介素-23，这两种蛋白参与了皮肤细胞过量增生和炎症过程。
Stelara的临床研发项目涉及了2,200多例患者，以两项关键的3期临床试验作为获得FDA批准的基础。在此两项临床试验中，与接受安慰剂的患者相比，在接受45 mg或90 mg剂量Stelara治疗12周后均有大量患者的病情获得至少75%的缓解，这是根据银屑病面积和严重程度指数（PASI）标准获得的数据（PASI 75）。经其后每12周1次的Stelara维持治疗，大部分获得PASI 75缓解的患者1年内可保持皮肤清爽。
Stelara的应用方式为皮下注射。此药在0周和第4周给药，其后每12周给药1次。对于体重≤100 kg（220磅）的患者，Stelara的建议起始剂量为45 mg，而对于体重>100 kg （220磅）的患者为90 mg。
Stelara会抑制免疫系统，因此可带来感染的风险。有接受Stelara治疗发生了严重感染的病例报告，有些患者还需要住院治疗。引起感染的因素包括病毒、真菌和细菌。在接受Stelara治疗之前，应排除患有结核，而且在治疗过程中应严密观注是否有结核的症状和体征。另外，接受Stelara治疗的患者应禁用活疫苗。
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