2014年1月23日，强生（JNJ）旗下杨森（Janssen）宣布，单抗药物Stelara（ustekinumab）获加拿大卫生部批准，单独用药或联合甲氨蝶呤（methotrexate），用于18岁及以上活动性银屑病关节炎（active psoriatic arthritis，PsA）成人患者的治疗，获批的治疗方法为：0周和4周皮下注射45mg Stelara，随后每12周皮下注射一次。
Stelara是首个也是唯一一个获批用于银屑病关节炎的抗IL-12/IL-23的药物。
Stelara的获批，是基于2项关键性III期研究PSUMMIT I和PSUMMIT II的结果。这2项研究评价了皮下注射给药Stelara（45mg或90mg）治疗银屑病关节炎的疗效和安全性。研究结果表明，2项研究均达到了主要终点。
银屑病关节炎（PsA）是一种慢性炎症性疾病，其中关节痛是由机体免疫系统攻击自身健康组织所致。该病约影响30%的银屑病（psoriasis）患者。
关于Stelara（ustekinumab）：
Stelara是单抗药物优特克单抗（ustekinumab）的商品名，是人白细胞介素IL-12和IL-23拮抗剂，已获批用于斑块型银屑病（plaque psoriasis）的治疗，该药通过与IL-12和IL-23所共有的p40亚单位相结合，阻止其与细胞表面的受体IL-12 β1相结合，来抑制这2种致炎性细胞因子（pro-inflammatory cytokine）。
IL-12和IL-23是2种天然存在的蛋白，被认为在免疫介导的炎症性疾病中发挥了关键作用，包括银屑病和银屑病关节炎。
此前，Stelara已于2013年9月获FDA和欧盟批准。
IMPORTANT HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use STELARA® safely and effectively. See full Prescribing Information for STELARA®.
CONTRAINDICATIONS
Clinically significant hypersensitivity to ustekinumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Infections: Serious infections have occurred. Do not start STELARA® during any clinically important active infection. If a serious infection develops, stop STELARA® until the infection resolves. (see Section 5.1 of the Prescribing Information)
Theoretical Risk for Particular Infections: Serious infections from mycobacteria, Salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Diagnostic tests for these infections should be considered as dictated by clinical circumstances. (See Section 5.2 of the Prescribing Information)
Tuberculosis (TB) evaluation: Evaluate patients for TB prior to initiating treatment with STELARA®. Initiate treatment of latent TB before administering STELARA®. (See Section 5.3 of the Prescribing Information)
Malignancies: STELARA® may increase risk of malignancy. The safety of STELARA® in patients with a history of or a known malignancy has not been evaluated. (See Section 5.4 of the prescribing Information)
Anaphylaxis or other clinically significant hypersensitivity reactions may occur. (See Section 5.5 of the Prescribing Information)
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, threat promptly and discontinue STELARA®. (See Section 5.6 of the Prescribing Information)
ADVERSE REACTIONS
Most common adverse reactions (incidence >3% and greater than with placebo): Nasopharyngitis, upper respiratory tract infection, headache, and fatigue. (See Section 6.1 of the Prescribing Information)