Patients with psoriasis are at increased risk of liver function abnormalities. Explore rates of hepatic treatment-emergent adverse events (TEAEs) and changes in liver parameters in bimekizumab-treated patients with psoriasis. Data are reported from 5 phase 3/3b trials over 2 years. Hepatic TEAEs, laboratory elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST), and changes in clinical markers of liver fibrosis (Fibrosis-4 [FIB-4] Index and AST to Platelet Ratio Index [APRI]) are reported. TEAEs are presented using exposure-adjusted incidence rates (EAIRs) per 100 patient-years (PY). 2186 patients received ≥1 bimekizumab dose. Over 2 years, the EAIR of hepatic TEAEs was 3.5/100 PY and did not increase from first to second year. 2-year EAIRs of ALT/AST elevations >3x and >5x the upper limit of normal were 2.3 and 0.6/100 PY; rates were similar to placebo, adalimumab, secukinumab, and ustekinumab during controlled study periods. FIB-4 and APRI scores did not increase through 2 years, regardless of fibrosis risk at baseline. Obesity, diabetes, dyslipidemia, chronic alcohol consumption, and medication changes are confounding factors for hepatic dysfunction. Rates of hepatic adverse events (AEs) with bimekizumab were consistent through 2 years; incidences of transaminase elevations were similar to comparators during phase 3/3b controlled study periods.

中文翻译：

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Bimekizumab 在中度至重度斑块状银屑病中的安全性：随机 3/3b 期试验中 2 年多的肝脏事件发生率和肝脏参数变化

牛皮癣患者肝功能异常的风险增加。探讨 Bimekizumab 治疗的银屑病患者肝脏治疗中出现的不良事件 (TEAE) 的发生率和肝脏参数的变化。数据来自 2 年 5 项 3/3b 期试验。报告了肝脏 TEAE、丙氨酸转氨酶 (ALT) 或天冬氨酸转氨酶 (AST) 的实验室升高以及肝纤维化临床标志物的变化（纤维化 4 [FIB-4] 指数和 AST 与血小板比率指数 [APRI]）。 TEAE 使用每 100 患者年 (PY) 的暴露调整发生率 (EAIR) 表示。 2186 名患者接受了≥1 剂量的 bimekizumab。 2年来，肝脏TEAE的EAIR为3.5/100 PY，并且从第一年到第二年没有增加。 ALT/AST 升高>3 倍和>5 倍正常上限的 2 年 EAIR 分别为 2.3 和 0.6/100 PY；在对照研究期间，发生率与安慰剂、阿达木单抗、苏金单抗和优特克单抗相似。无论基线时的纤维化风险如何，FIB-4 和 APRI 评分在 2 年内都没有增加。肥胖、糖尿病、血脂异常、长期饮酒和药物改变是肝功能障碍的混杂因素。 Bimekizumab 的肝脏不良事件 (AE) 发生率在 2 年内保持一致；在 3/3b 期对照研究期间，转氨酶升高的发生率与对照组相似。