制造商：
Centocor Ortho生技公司公司
药理分类：
白细胞介素12和白细胞介素23拮抗剂
活性成分（补）：
Ustekinumab 45mg/0.5mL;溶液为SC损伤;不含防腐剂。
指示（补）：
中度到成年人谁是光疗或全身治疗重度斑块型银屑病的候选人。
药理作用：
Ustekinumab是人类IgG1k对白细胞介素- 12和IL - 23 p40的亚基单克隆抗体。这些细胞因子参与炎症和免疫反应，如自然杀伤细胞的活化和CD4 + T细胞分化和激活。 Ustekinumab被证明在体外破坏白细胞介素12和IL - 23介导的信号，并通过破坏与共享细胞表面受体相互作用的细胞因子，这些细胞因子的级联。
临床试验：
两个双盲，安慰剂控制的研究是在18岁以上的患者牛皮癣谁属光疗或全身治疗候选人老。患者至少有10％的身体表面的参与和银屑病面积和严重程度指数（PASI），≥12分;基线的PASI分数约17-18不等。与点滴状，红皮，或脓疱性银屑病患者被排除在外。
对于这两项研究中，受试者被随机分配到ustekinumab 45mg，90毫克或安慰剂。这些随机ustekinumab收到45mg或90毫克，无论重量，周0，4和16。那些与安慰剂随机收到0和4周安慰剂，并越过ustekinumab在12周和16 45mg或90毫克。在终点为科目谁实现了从基线至少在的PASI评分减少75％至12周（PASI评分75）和治疗成功对医师的全球评估，这表明医生的牛皮癣进行全面评估（清除或很少）的比例，在厚度，硬结，红斑和缩放为重点。 PGA的得分为基准标记或在44个研究中的1 766和40％的受试者在研究1230年2％的受试者严重。

在研究一，达到67％的PASI 75的ustekinumab 45mg组中，66％的患者90毫克，3％，在安慰剂组。在研究二，67％的患者给予45mg ustekinumab达到76 PASI评分给予75％的患者ustekinumab 90毫克，而4％的安慰剂。

法律分类：
接收

成人：
≥18yrs：≤一百千克：45mg一次，然后4wks资深大律师后，再一次12wks。 >一○○千克：90毫克一次，然后4wks后，再一次12wks。旋转已经来到现场。

儿童：
“18yrs：不推荐。

警告/注意事项：
主动感染：不推荐。增加对严重或致命的感染，尤其危险。在IL-12/IL-23基因缺陷患者（如，分枝杆菌，沙门氏菌，卡介苗疫苗）。新感染监控;停止，如果严重感染发展。条件，易患感染。测试和治疗潜伏肺结核开始治疗之前。避免与其密切接触活疫苗者。历史的恶性肿瘤。可逆性后部白质脑病如果停止综合征（RPLS）发生或怀疑。老人。妊娠（Cat.B）。哺乳的母亲。

互动（补）：
伴随活疫苗，其他免疫抑制剂，光疗：不推荐。不要给卡介苗期间或在1年内启动或停止ustekinumab疫苗。非活疫苗：可能会不理想的反应。可能会影响细胞色素P450基板。

不良反应（补）：
鼻咽炎，上呼吸道感染，头痛，疲劳，感染，恶性肿瘤，RPLS。

如何提供：
一次性使用瓶（0.5mL）-1

最后更新：
09年11月5日

STELARA

Manufacturer: Centocor Ortho Biotech, Inc. Pharmacological Class: Interleukin-12 and interleukin-23 antagonist Active Ingredient(s): Ustekinumab 45mg/0.5mL; soln for SC inj; preservative-free. Indication(s): Moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. Pharmacology: Ustekinumab is a human IgG1k monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23. These cytokines are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. Ustekinumab was shown in vitro to disrupt interleukin-12 and interleukin-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor. Clinical Trials: Two double-blind, placebo-controlled studies were conducted in patients 18 years or older with plaque psoriasis who were candidates for phototherapy or systemic therapy. The patients had at least 10% body surface involvement and a Psoriasis Area and Severity Index (PASI) score of ≥12; baseline PASI scores ranged from about 17–18. Patients with guttate, erythrodermic, or pustular psoriasis were excluded. For both studies, subjects were randomized to ustekinumab 45mg, 90mg, or placebo. Those randomized to ustekinumab received 45mg or 90mg, regardless of weight, at weeks 0, 4, and 16. Those randomized to placebo received placebo at weeks 0 and 4, and were crossed over to ustekinumab 45mg or 90mg at weeks 12 and 16. The endpoints were the proportion of subjects who achieved at least a 75% reduction in the PASI score from baseline to week 12 (PASI 75) and treatment success (cleared or minimal) on the Physician's Global Assessment, which indicates the physician's overall assessment of psoriasis, focusing on thickness, induration, erythema, and scaling. Baseline PGA score was marked or severe in 44% of the 766 subjects in Study 1 and in 40% of the 1230 subjects in Study 2. In Study 1, 67% of patients achieved PASI 75 in the ustekinumab 45mg group, 66% in the 90mg, and 3% in the placebo group. In Study 2, 67% of patients given 45mg ustekinumab and 76% of patients given ustekinumab 90mg achieved PASI 75, compared to 4% for placebo. Legal Classification: Rx Adults: ≥18yrs: ≤100kg: 45mg SC once then 4wks later, then once every 12wks. >100kg: 90mg once then 4wks later, then once every 12wks. Rotate inj site. Children: <18yrs: not recommended. Warnings/Precautions: Active infections: not recommended. Increased risk of serious or fatal infections, esp. in IL-12/IL-23 genetically deficient patients (eg, mycobacteria, salmonella, BCG vaccines). Monitor for new infection; discontinue if serious infection develops. Conditions that predispose to infection. Test for and treat latent tuberculosis prior to initiating therapy. Avoid close contact with live vaccine recipients. History of malignancies. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs or is suspected. Elderly. Pregnancy (Cat.B). Nursing mothers. Interaction(s): Concomitant live vaccines, other immunosuppressants, phototherapy: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. May affect CYP450 substrates. Adverse Reaction(s): Nasopharyngitis, upper respiratory tract infection, headache, fatigue; infections, malignancies, RPLS. How Supplied: Single use vial (0.5mL)—1