Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
Drugs. 2017 Jul;77(10):1105-1114. doi: 10.1007/s40265-017-0765-6.
Ustekinumab (Stelara) has been recently approved in the EU and the USA as intravenous induction and subcutaneous maintenance therapy for adult patients with moderately to severely active Crohn's disease who have failed or were intolerant to treatment with immunomodulators, corticosteroids or at least one tumour necrosis factor (TNF) antagonist. Ustekinumab, a monoclonal antibody to the shared p40 subunit of the proinflammatory interleukin (IL)-12 and IL-23 cytokines, has a unique mechanism of action distinct from that of TNF antagonists. In pivotal phase III trials, compared with placebo, ustekinumab induction therapy improved clinical response and remission rates in patients who had previously failed or were intolerant to conventional therapies or at least one TNF antagonist. When administered as subcutaneous maintenance therapy, ustekinumab continued to offer benefits over placebo for clinical response and remission in patients who had clinically responded to the induction therapy. Ustekinumab was generally well tolerated as both induction and maintenance therapy; serious infections and malignancies were rare. Thus, ustekinumab presents a promising alternative treatment option in patients with moderately to severely active Crohn's disease who have failed or are intolerant to treatment with conventional therapies or TNF antagonists.
乌司奴单抗（喜达诺）最近在欧盟和美国获批，用于治疗对免疫调节剂、皮质类固醇或至少一种肿瘤坏死因子（TNF）拮抗剂治疗应答不佳或不耐受的中重度活动性克罗恩病成年患者，作为静脉诱导和皮下维持治疗药物。乌司奴单抗是一种针对促炎白细胞介素（IL）-12 和 IL-23 细胞因子的 p40 共享亚单位的单克隆抗体，其作用机制与 TNF 拮抗剂不同。在关键性 III 期试验中，与安慰剂相比，乌司奴单抗诱导治疗可改善先前对常规治疗或至少一种 TNF 拮抗剂应答不佳或不耐受的患者的临床应答和缓解率。在诱导治疗应答的患者中，作为皮下维持治疗，乌司奴单抗继续提供优于安慰剂的临床应答和缓解获益。乌司奴单抗作为诱导和维持治疗均具有良好的耐受性；严重感染和恶性肿瘤罕见。因此，乌司奴单抗为对常规治疗或 TNF 拮抗剂治疗应答不佳或不耐受的中重度活动性克罗恩病患者提供了一种有前景的治疗选择。
