首页> 外文期刊>Journal of the European Academy of Dermatology and Venereology: JEADV >Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study.
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Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study.

机译:依法珠单抗治疗台湾中度至重度斑块状牛皮癣患者的临床有效性和安全性经验:一项开放性单臂先导研究的结果。

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摘要

BACKGROUND: No clinical trial of efalizumab has been conducted in Asia. OBJECTIVE: To determine the efficacy and safety of efalizumab in Taiwanese patients with psoriasis. METHODS: This is an open-label, single-arm pilot study conducted at two centres. Patients were given 1 mg/kg efalizumab subcutaneously once a week for 12 weeks and were then followed up for a further 12 weeks. RESULTS: A total of 49 patients participated in the study. The median improvement in Psoriasis Area and Severity Index (PASI) during the treatment period was 19.6%, and a >or= 50% improvement in PASI was seen in 20.4%. Rebound was seen in 17.8% of patients, and anti-efalizumab antibodies were detected in 41% of patients. The most frequent adverse events were headache (34.7%), arthralgia/arthritis (28.6%), psoriasis events (new form/exacerbation; 26.5%) and pruritus (22.4%). CONCLUSIONS: This small pilot study indicated that efalizumab was effective in improving psoriasis symptoms in Taiwanese patients, with no new safety issuesidentified.
机译:背景:在亚洲尚未进行依法珠单抗的临床试验。目的:探讨依法珠单抗在台湾银屑病患者中的疗效和安全性。方法:这是在两个中心进行的开放标签,单臂试验研究。每周一次给患者皮下注射1 mg / kg的efalizumab,持续12周,然后再随访12周。结果:共有49名患者参加了该研究。在治疗期间,牛皮癣面积和严重程度指数(PASI)的中位数改善为19.6%,而PASI改善≥50%的为20.4%。在17.8%的患者中发现了反弹,在41%的患者中检测到了抗依法珠单抗抗体。最常见的不良事件是头痛(34.7%),关节痛/关节炎(28.6%),牛皮癣事件(新形式/病情加重; 26.5%)和瘙痒(22.4%)。结论:这项小型先导研究表明,依法珠单抗可有效改善台湾患者的牛皮癣症状,未发现新的安全性问题。

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