Hoffmann Jochen H, Knoop Christian, Enk Alexander H, Hadaschik Eva N
Department of Dermatology, University Hospital Heidelberg, DE-69115 Heidelberg, Germany.
Acta Derm Venereol. 2017 Jun 9;97(6):705-710. doi: 10.2340/00015555-2644.
Only limited data on laboratory parameter dynamics and safety under prolonged biologic treatment in a "real-world" scenario are available for recommendations on screening and monitoring. This study is a retrospective analysis of routine parameter dynamics and laboratory adverse events (LAE) in psoriasis patients on long-term treatment (n = 199) with tumour necrosis factor (TNF)-α-antagonists (adalimumab, etanercept), and the interleukin (IL)12/23-antagonist ustekinumab. Overall, neutrophil (PMN) counts (-11%) and triglycerides (+9%) changed considerably. TNF-α-antagonists and ustekinumab differentially affected lymphocyte counts (+13% and ±0%, respectively). Dynamics were pronounced during the first 180 days of treatment. In 340 treatment-years, 15 Common Terminology Criteria for Adverse Events (CTCAE) III-IV° LAE were recorded (11 involved liver enzymes). They prompted alteration of the biologic regime in only 2 cases. Age, sex, previous systemic treatments, and psoriatic arthritis did not significantly predict LAE. Liver enzyme and triglyceride screening may be warranted in some instances. Our data suggest that unguided monitoring of other routine laboratory parameters is unnecessary under long-term biologic treatment.
在“真实世界”场景中，关于长期生物治疗下实验室参数动态变化和安全性的可用数据有限，无法为筛查和监测提供建议。本研究是一项回顾性分析，针对长期接受肿瘤坏死因子（TNF）-α拮抗剂（阿达木单抗、依那西普）和白细胞介素（IL）12/23拮抗剂乌司奴单抗治疗的银屑病患者（n = 199）的常规参数动态变化和实验室不良事件（LAE）。总体而言，中性粒细胞（PMN）计数（-11%）和甘油三酯（+9%）有显著变化。TNF-α拮抗剂和乌司奴单抗对淋巴细胞计数的影响不同（分别为+13%和±0%）。治疗的前180天内变化明显。在340个治疗年中，记录了15例按照不良事件通用术语标准（CTCAE）III-IV°的LAE（11例涉及肝酶）。仅2例因此改变了生物治疗方案。年龄、性别、既往全身治疗和银屑病关节炎并不能显著预测LAE。在某些情况下，可能有必要进行肝酶和甘油三酯筛查。我们的数据表明，在长期生物治疗下，对其他常规实验室参数进行无指导的监测是不必要的。
