Llamas-Velasco M, Concha-Garzón M J, García-Diez A, Daudén E
Instituto de Investigación Sanitaria Princesa (IP), Madrid, España; Departamento de Dermatología, Hospital Universitario de la Princesa, Madrid, España.
Departamento de Dermatología, Hospital Universitario de la Princesa, Madrid, España.
Actas Dermosifiliogr. 2015 Jul-Aug;106(6):470-6. doi: 10.1016/j.ad.2015.02.002. Epub 2015 Apr 22.
The therapy of patients with psoriasis and liver disease can be a challenge due to the increased risk of adverse effects from traditional systemic treatments; in addition, although the anti-tumor necrosis factor agents are considered safer, they have also been associated with drug-induced liver injury and reactivation of viral hepatitis. Ustekinumab has a different mechanism of action and the little that is known of its effects on the liver comes from pivotal studies. The objectives of this study were to estimate the incidence of drug-induced liver injury in patients treated with ustekinumab in daily clinical practice and to analyze liver alterations in those patients with pre-existing liver disease.
All patients treated with the standard regimen of ustekinumab were included in the study. Variables gathered included age, sex, type of psoriasis, nail involvement, arthritis, previous treatments, history of liver disease, viral serology, Psoriasis Area Severity Index (at baseline and at 12, 16, and 52 weeks), transaminase levels, manifestations of liver disease, liver ultrasound, and factors such as body mass index, alcohol consumption, and ferritin levels.
Grade 1 elevation of the transaminases was only observed in 6 patients; no cases of severe hypertransaminasemia were observed. None of the patients with elevation of the transaminases at baseline developed problems during treatment.
Ustekinumab-related liver injury is uncommon and mild. From a hepatic point of view, the drug appears safe, even in patients with pre-existing liver disease and those who have developed altered liver function previously with other drugs.
银屑病合并肝脏疾病患者的治疗颇具挑战,因为传统全身治疗的不良反应风险增加;此外,尽管抗肿瘤坏死因子药物被认为更安全,但它们也与药物性肝损伤和病毒性肝炎再激活有关。乌司奴单抗作用机制不同,目前对其肝脏影响的了解甚少,来自关键研究。本研究的目的是评估乌司奴单抗在日常临床实践中治疗患者药物性肝损伤的发生率,并分析那些已有肝脏疾病患者的肝脏改变情况。
所有接受乌司奴单抗标准方案治疗的患者纳入本研究。收集的变量包括年龄、性别、银屑病类型、指甲受累情况、关节炎、既往治疗、肝脏疾病史、病毒血清学、银屑病面积和严重程度指数(基线时以及第12、16和52周)、转氨酶水平、肝脏疾病表现、肝脏超声以及诸如体重指数、饮酒量和铁蛋白水平等因素。
仅6例患者观察到1级转氨酶升高;未观察到严重高转氨酶血症病例。基线时转氨酶升高的患者在治疗期间均未出现问题。
乌司奴单抗相关肝损伤不常见且程度较轻。从肝脏角度来看,该药物似乎是安全的,即使是已有肝脏疾病以及先前使用其他药物出现肝功能改变的患者。