Departments of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, 7 Chung-Shan South Road, Taipei, 100, Taiwan; Department of Dermatology, Hsin-Chu Branch, National Taiwan University Hospital, Hsin-Chu, Taiwan.
Br J Dermatol. 2013 Dec;169(6):1295-303. doi: 10.1111/bjd.12461.
Ustekinumab, an interleukin (IL)-12 and IL-23 blocker, has emerged as a new therapeutic option for patients with psoriasis. It is generally well tolerated but safety data on the use of ustekinumab in patients with viral hepatitis are limited.
To assess the safety profile of ustekinumab in the treatment of patients with psoriasis who have concomitant hepatitis B or hepatitis C.
This study included 18 patients with concurrent psoriasis and hepatitis B virus (HBV) infection (14 patients) or hepatitis C virus (HCV) infection (four patients) who were treated with at least two ustekinumab injections. Viral loads were measured at baseline and each time before the administration of ustekinumab. Relevant clinical data were recorded.
Among 11 patients positive for hepatitis B surface antigen (HBsAg), two out of the seven (29%) patients who did not receive antiviral prophylaxis exhibited HBV reactivation during ustekinumab treatment. No viral reactivation was observed in the three occult HBV-infected patients (HBsAg-negative/hepatitis B core antibody-positive patients). One patient with HCV, liver cirrhosis and treated hepatocellular carcinoma (HCC) experienced HCV reactivation and recurrent HCC during the ustekinumab treatment. No significant increase in aminotransferase levels was observed in any patient.
Antiviral prophylaxis appears to minimize the risk of viral reactivation in patients with concurrent psoriasis and HBV infection. Without effective anti-viral prophylaxis, the risk/benefit of ustekinumab treatment should be carefully assessed in patients with psoriasis and HBV or HCV infection and/or HCC. Close monitoring for HBV and HCV viral load is recommended, particularly for patients with high-risk factors. Serum aminotransferase determination may not be useful for early detection of viral reactivation.
乌司奴单抗是一种白细胞介素（IL）-12 和 IL-23 抑制剂，已成为治疗银屑病患者的新选择。它通常具有良好的耐受性，但乌司奴单抗在乙型肝炎或丙型肝炎患者中的使用安全性数据有限。
评估同时患有乙型肝炎病毒（HBV）或丙型肝炎病毒（HCV）感染的银屑病患者使用乌司奴单抗的安全性。
本研究纳入了 18 例同时患有乙型肝炎病毒感染（14 例）或丙型肝炎病毒感染（4 例）的银屑病患者，这些患者至少接受了两次乌司奴单抗注射。在基线和每次使用乌司奴单抗前均测量了病毒载量，并记录了相关临床数据。
在 11 例乙型肝炎表面抗原（HBsAg）阳性患者中，7 例未接受抗病毒预防的患者中有 2 例（29%）在乌司奴单抗治疗期间出现 HBV 再激活。3 例隐匿性 HBV 感染患者（HBsAg 阴性/乙型肝炎核心抗体阳性）未观察到病毒再激活。1 例丙型肝炎、肝硬化和治疗后肝癌（HCC）的患者在乌司奴单抗治疗期间出现 HCV 再激活和 HCC 复发。未观察到任何患者的氨基转移酶水平显著升高。
抗病毒预防似乎可降低同时患有银屑病和 HBV 感染患者发生病毒再激活的风险。对于同时患有银屑病和 HBV 或 HCV 感染和/或 HCC 的患者，在使用乌司奴单抗治疗时，应仔细评估风险/获益比。建议密切监测 HBV 和 HCV 病毒载量，尤其是对于具有高危因素的患者。血清氨基转移酶测定可能对早期检测病毒再激活不敏感。
