2016年3月22日，美国食品和药品管理监督局(FDA)批准Taltz®(Ixekizumab)80mg/mL注射剂用于那些适用于全身性治疗或光疗治疗的中重度斑块状银屑病成年患者。Taltz不应当用于既往对Ixekizumab过敏或对其中任何赋形剂过敏的患者（如速发过敏反应）。Taltz作用于特异性靶点IL-17A-一种可引发银屑病基础性炎症的蛋白。
银屑病是一种影响皮肤的慢性、免疫性疾病。在美国，银屑病累及约750万人口，其中约20%为中重度斑块状银屑病患者。斑块状银屑病是最常见的银屑病形式，表现为身体表面抬高的红色斑块，上面堆积覆盖银白色的皮肤死细胞，患者常有疼痛或瘙痒。银屑病的确切病因不明，但已了解到遗传和环境因素对于该疾病的发生起到一定作用。
“很多银屑病患者仍在寻求如何才能成功控制这种疾病的治疗方法。”礼来美国总裁Alex Azar表示：“随着Taltz的获批，我们非常自豪能为患者提供一种新的治疗方案，帮助患者取得皮损实质性消退甚至是皮损完全消退。”
FDA对于Taltz的批准是基于迄今为止获准进行的最大规模III期临床试验结果，该试验共入组21个国家逾3800例中重度斑块状银屑病患者。该入组患者数量包括临床试验中开始接受Taltz或安慰剂、或活性对比药物（美国批准的依那西普）的患者。该临床试验包括了三项双盲、多中心、3期研究--UNCOVER-1、UNCOVER-2和UNCOVER-3--这些研究证实了Taltz用于中重度斑块状银屑病患者的安全性和有效性。全部三项研究均评价了12周后Taltz（在160-mg起始剂量后，每2周或4周80mg）相较于安慰剂的安全性和有效性。此外，UNCOVER-2和 UNCOVER-3研究还包括了一个对比药物组，该组患者接受在美批准的依那西普（50mg，每周两次）治疗，为期12周。UNCOVER-1和 UNCOVER-2还评价了60周维持期内Taltz的应答率。
这些研究在治疗12周时复合主要有效性终点是银屑病面积严重性指数 (PASI) 评分取得75%改善，以及静态医生整体评分(sPGA)为0或1（自基线至少改善2分）。PASI通过评估受损皮肤的平均发红程度、厚度和鳞屑（分别根据0到4分量表分级），测量以受累皮肤所占体表面积加权的银屑病程度和严重性，而sPGA 是医生在特定时间点上对银屑病患者病损严重性的评估，而且是 FDA 评估有效性的一个必需的测量指标。
在全部三项研究中，87%-90%的患者使用Taltz治疗12周后出现了银屑病斑块的显著改善 (PASI75)。此外，Taltz 治疗的患者中有81%-83%取得了sPGA 0或1。大部分接受Taltz治疗的患者(68%-71%) 取得了皮损实质性消退(PASI 90)，并有35%-42%的患者出现了银屑病完全消退(PASI 100, sPGA 0)。接受安慰剂的患者仅有7%或更少取得PASI 75、仅有7%或更少取得sPGA 0或1、仅有3%或更少取得PASI 90以及仅有1%或更少取得PASI 100和sPGA 0。
在研究 UNCOVER-1和UNCOVER-2中，12周时对Taltz应答的患者（sPGA 0或1，至少自基线至少改善2分）中有75%直至60周终点始终维持治疗应答。
Taltz的皮损消退（包括12周时的PASI 75和sPGA 0或1）均优于在美批准的依那西普，且差别有统计学显著性。在对两项活性药物对比研究（UNCOVER-2 和 UNCOVER-3）的美国研究中心结果进行的整合分析中，Taltz与美批准的依那西普治疗应答率比较，PASI 75分别为87%和27%，而sPGA 0或1分别为73%和27%。
有关Taltz安全性的数据源于4204例自愿参加对照和非对照临床试验的中重度斑块状银屑病患者构成的数据库。
Taltz可能增加感染风险。相较于安慰剂组患者，接受Taltz治疗的患者有较高的感染率(27% vs 23%)。与安慰剂组相比，上呼吸道感染、口腔念珠菌病、结膜炎和癣感染更常见于接受Taltz治疗的患者。曾出现严重感染病例。如果出现有临床重要性的慢性或急性感染的症状或体征，应指导患者就医诊治。如果出现严重感染，应停用Taltz直至感染消失。
Taltz治疗的其他警告和注意事项包括治疗前对结核、超敏反应、炎性肠病和免疫状况进行评估。
在UNCOVER-2和UNCOVER-3中，在美批准的依那西普在研究的诱导期（0-12周）内的严重不良事件发生率为0.7%，Taltz为2%。依那西普因不良事件停药的发生率为0.7%，Taltz为2%。依那西普的感染发生率为18%，Taltz为26%。依那西普和Taltz的严重感染发生率均为0.3%。
“皮肤斑块皮损完全消退是银屑病治疗的一个重要目标。”主要研究作者、圣路易斯大学医学院医学临床皮肤学教授Craig Leonardi博士表示：“Taltz的获批，使医生有了一个新的选择来帮助患者取得皮损实质性消退或完全消退；事实上，10例患者中有4例可取得皮损完全消退。基于这些研究结果，医生可以让患者治疗安心，因为Taltz可提供持续稳定的治疗效果。”
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs. 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.
Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each < 0.1%), occurred in the Taltz group in clinical trials. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.
Immunizations
Prior to initiating therapy with Taltz, consider completion of all age appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.
ADVERSE REACTIONS
Most common adverse reactions (>1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
See accompanying Prescribing Information and Medication Guide. See Instructions for Use included with the device.
IX HCP ISI 22MAR2016
About Taltz®
Taltz® (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.  Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
About the UNCOVER Studies
The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicenter, Phase 3 studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries. All three studies evaluated the safety and efficacy of different dosing regimens of Taltz (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received U.S.-approved etanercept (50 mg twice a week) for 12 weeks. In UNCOVER-1 and UNCOVER-2, safety and efficacy of Taltz was further evaluated through 60 weeks.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, immune disease that affects the skin.3 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.3 It is the most common inflammatory disease in the United States, affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.3 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.3 Approximately 20 percent of people with psoriasis have moderate-to-severe plaque psoriasis.4
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac96658a-d7dc-4c7c-8928-2adcdf4318b2