Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, 80131, Naples, Italy.
Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
Clin Drug Investig. 2022 Jun;42(6):525-531. doi: 10.1007/s40261-022-01163-5. Epub 2022 May 28.
Biologics for psoriasis, especially anti-tumor necrosis factor-α therapies, may reactivate hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, as well in inactive carriers or patients with occult infection. However, some biologics, including anti-interleukin-17 therapies such as secukinumab, seem to be less likely to cause hepatitis reactivation. This study assessed the safety of secukinumab treatment in patients with psoriasis with HBV or HBC infection.
This was a retrospective cohort study of patients with moderate-to-severe psoriasis treated with secukinumab at seven Italian centers. Patients serologically positive for one or more of the following viral hepatitis markers were included: HCV antibody (± HCV-RNA positivity) and/or hepatitis B surface antigen, and/or HBV core antibody and/or HBV surface antibody (± HBV-DNA positivity). Patients received secukinumab 300 mg subcutaneously at week 0/1/2/3/4 then every 4 weeks; prophylactic therapy before starting secukinumab was prescribed where indicated. The primary study endpoint was the reactivation of hepatitis viral infection, defined as conversion to HBV-DNA or HCV-RNA positivity, with or without elevation of transaminases.
Sixty patients (17 with concomitant psoriatic arthritis) were included. Thirteen subjects were hepatitis B surface antigen positive, 19 were HBV core antibody positive, and 30 were positive for the HCV antibody; however, all were HCV-RNA negative. After 53.5 ± 37.5 weeks of secukinumab therapy, hepatitis reactivation occurred in only one patient, who had a reactivation of both hepatitis B and hepatitis C. This patient had not undergone hepatitis B prophylaxis or hepatitis C treatment before secukinumab.
These real-world data support the safety of secukinumab in patients with positive markers of HBV or HCV infection, when administered together with dedicated prophylaxis.
生物制剂治疗银屑病，特别是抗肿瘤坏死因子-α治疗，可能会重新激活乙型肝炎病毒（HBV）或丙型肝炎病毒（HCV）感染，包括在非活动携带者或隐匿性感染患者中。然而，一些生物制剂，包括抗白细胞介素-17 治疗药物如司库奇尤单抗，似乎不太可能引起肝炎再激活。本研究评估了司库奇尤单抗治疗乙型肝炎病毒或丙型肝炎病毒感染的银屑病患者的安全性。
这是一项回顾性队列研究，纳入了在意大利七个中心接受司库奇尤单抗治疗的中重度银屑病患者。患者的血清学检测结果为以下一种或多种病毒肝炎标志物阳性：丙型肝炎病毒抗体（±丙型肝炎病毒 RNA 阳性）和/或乙型肝炎表面抗原，和/或乙型肝炎核心抗体和/或乙型肝炎表面抗体（±乙型肝炎病毒 DNA 阳性）。患者在第 0/1/2/3/4 周时接受司库奇尤单抗 300 mg 皮下注射，此后每 4 周 1 次；根据需要在开始司库奇尤单抗治疗前预防性治疗。主要研究终点是肝炎病毒感染的再激活，定义为乙型肝炎病毒 DNA 或丙型肝炎病毒 RNA 阳性，伴有或不伴有转氨酶升高。
共纳入 60 例患者（17 例合并银屑病关节炎）。13 例患者乙型肝炎表面抗原阳性，19 例乙型肝炎核心抗体阳性，30 例丙型肝炎病毒抗体阳性；然而，所有患者的丙型肝炎病毒 RNA 均为阴性。在接受司库奇尤单抗治疗 53.5±37.5 周后，仅 1 例患者发生乙型肝炎和丙型肝炎双重再激活。该患者在接受司库奇尤单抗治疗前未接受乙型肝炎预防治疗或丙型肝炎治疗。
这些真实世界数据支持在联合专门预防措施的情况下，司库奇尤单抗在乙型肝炎病毒或丙型肝炎病毒感染标志物阳性的患者中的安全性。
