3月22日，美国FDA批准Taltz（ixekizumab）治疗中重度斑块状银屑病成人患者。银屑病是一种自体免疫性皮肤疾病。在有银屑病家族史的患者中，这种疾病的发生频率更高，通常始自于 15 至 35 岁的人。最常见形式的银屑病是斑块状银屑病，这种疾病患者会出现厚厚的红色皮肤，有片状的银白色鳞屑。
今天的批准为斑块状银屑病患者提供了另一种重要的治疗选择，可以帮助缓解疾病导致的皮肤刺激及不适感，FDA药物评价与研究中心药物评价III办公室主任、医学博士 Beitz 称。
Taltz的活性成分是一种抗体（ixekizumab），它可以与一种能引起炎症的蛋白（白介素 -17A）相结合。通过结合这种蛋白，Ixekizumab能够抑制在斑块状银屑病发展中起作用的炎症反应。Taltz以注射剂使用。该药物适用于准备全身性治疗（以口服或注射后通过血流的物质进行治疗）、光疗（紫外光治疗）或两者都有的患者。
Taltz的安全性及有效性基于三项随机、安慰剂对照临床试验，总共有3866名准备进行全身性治疗或光疗的斑块状银屑病患者。结果显示，Taltz与安慰剂相比达到了更好的响应，根据皮肤银屑病病变的程度、性质及严重度进行评分，Taltz治疗患者的皮肤获得清除或几乎清除。
由于Taltz是一种影响免疫系统的药物，该药物的说明书告知患者他们可能有更大的感染、过敏或自身免疫疾病风险。严重过敏反应及炎症性肠病发展或恶化在 Taltz的使用中已有报道。最常见的副作用包括上呼吸道感染、注射部位反应及真菌感染。Taltz由印第安纳州的礼来公司上市销售
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 eva luation for Tuberculosis
eva luate 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 <</span> 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. |
