Limited information is available regarding the effect of hepatic impairment (HI) on the pharmacokinetics of monoclonal antibodies (mAbs). The results of an earlier report based on therapeutic proteins, including mAbs, approved through the end of 2012 were inconclusive due to limited HI data available at that time. New HI data for mAbs or antibody-drug conjugates (ADCs; with a focus on the mAb component) available between 2013 and 2018 were evaluated. The investigation indicates there is almost no data for severe HI, limited data for moderate HI, and abundant data for mild HI. A significant exposure decrease was found for several mAbs or ADCs and a trend for decreasing area under the concentration-time curve (AUC) was observed for other mAbs. Multiple potential mechanisms may contribute to the exposure decrease. Dose may need to be adjusted for patients with HI, after taking into account the exposure-response relationships for both efficacy and safety.

中文翻译：

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肝功能不全会影响单克隆抗体的暴露吗？

关于肝功能损害（HI）对单克隆抗体（mAbs）药代动力学的影响的信息有限。截止到2012年底，基于治疗性蛋白质（包括mAb）的早期报告的结果尚无定论，因为当时的HI数据有限。评估了2013年至2018年之间可获得的mAb或抗体-药物偶联物（ADC;重点是mAb组分）的新HI数据。调查表明，几乎没有重度HI数据，中度HI数据有限，轻度HI数据丰富。发现几个mAb或ADC的暴露量显着减少，而其他mAb的浓度-时间曲线（AUC）下的面积却有减小的趋势。多种潜在机制可能有助于减少暴露。