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首页> 外文期刊>Drugs of today: Medicamentos de actualidad >Brodalumab: the first anti- IL-17 receptor agent for psoriasis
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Brodalumab: the first anti- IL-17 receptor agent for psoriasis

机译：Brodalumab：牛皮癣的第一抗IL-17受体剂

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Psoriasis is a chronic immune-mediated inflammatory skin disease in which the alteration of the interleukin-23 (IL-23)/IL-17 cytokine axis appears to be crucial from a pathogenetic perspective. This has been confirmed by the efficacy of monoclonal antibodies blocking IL-17A, such as secukinumab and ixekizumab. Brod-alumab is a human anti-IL-17 receptor A (IL-17RA) monoclonal antibody that inhibits the biological activity of IL-17A, IL-17F and other IL-17 isoforms, and has been approved (210 mg s.c. at weeks 0, 1, 2 and every 2 weeks thereafter) for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma in Japan (Lumicef). The U.S. Food and Drug Administration has also recently approved brodalumab (Siliq) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Regulatory applications are under review in the E.U. and Canada. The phase III clinical trials in moderate to severe plaque psoriasis met their primary endpoints after 12 weeks' treatment, with PASI 75 (75% improvement in the Psoriasis Area and Severity Index) response rates ranging between 83% and 86% (210 mg) and PASI 100 response rates ranging between 37% and 44%, significantly higher than those achieved with ustekinumab in the head-to-head trials AMAGINE-1 and AMAGINE-2. The most frequently reported adverse events in brodalumab clinical trials consisted of nasopharyngitis, headache, upper respiratory tract infection and arthralgia. In the head-to-head trials, rates of neutropenia were higher with both active drugs than with placebo, and mild or moderate Candida infections were more frequent with brodalumab than with ustekinumab or placebo. Clinical development was terminated by Amgen after adverse events of suicidal ideation and behavior were observed in clinical trials involving several indications, but data are inconclusive regarding potential drug causality, and brodalumab has recently been approved in the U.S. with a black box warning and a risk-management program regarding suicidal issues. Blocking IL-17RA provides a highly efficacious therapeutic alternative for moderate to severe psoriasis with a satisfactory safety profile.
机译：牛皮癣是一种慢性免疫介导的炎症皮肤病，其中白细胞介素-33（IL-23）/ IL-17细胞因子轴的改变似乎是来自致病性的观点至关重要的。这已经通过单克隆抗体阻断IL-17A，例如Secukinumab和Ixekizumab的疗效证实。 Brod-Alumab是一种人抗IL-17受体A（IL-17RA）单克隆抗体，其抑制IL-17A，IL-17F和其他IL-17同种型的生物活性，并已被批准（周数210mg SC 0,1,2和每2周后）用于治疗日本（Lumicef）的牛皮癣，银屑病关节炎，脓疱性牛皮癣和银屑病红霉菌。美国食品和药物管理局最近批准了Brodalumab（Siliq），用于治疗成年患者中度至重度斑块牛皮癣，该患者是全身治疗或光疗法的候选者，并且未能应对或对其他全身疗法丧失反应。监管申请在E.U中正在审查。和加拿大。中度至重度斑块牛皮癣的III期临床试验在治疗12周后达到其主要终点，PASI 75（牛皮癣面积的提高75％和严重程度指数）的响应率在83％和86％（210mg）之间的响应率范围内PASI 100的反应率范围在37％至44％之间，显着高于Ostekinub在头部到头试验Amagine-1和Amagine-2中实现的速率。 Brodalumab临床试验中最常报告的不良事件包括鼻咽炎，头痛，上呼吸道感染和关节痛。在头部到头试验中，中性药物的速率比与安慰剂的活性药物较高，并且在Brodalumab比Ustekinubab或安慰剂中更频繁地频繁，温和或中度的念珠菌感染更频繁。在临床试验中观察到涉及几种适应症的临床试验中，临床试验中观察到的临床发展，但潜在的药物因果关系，临床试验中的行为终止，并且在美国的黑匣子警告和风险批准了数据，而且风险最近批准了Brodalumab - 关于自杀问题的管理计划。阻断IL-17RA为中度至严重牛皮癣提供高度有效的治疗替代方案，具有令人满意的安全性。

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