Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.
Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.
Most systemic agents used for moderate-to-severe atopic dermatitis (AD) may lead to adverse events requiring routine laboratory monitoring, increasing patient burden and possibly decreasing treatment adherence.
To evaluate clinical laboratory findings in adults with moderate-to-severe AD treated with dupilumab up to 3 years.
LIBERTY AD OLE (NCT01949311) was a phase 3, multicenter, open-label extension study in adults with moderate-to-severe AD receiving dupilumab 300 mg weekly.
2,677 patients were treated up to 3 years. No clinically meaningful changes in mean hematology/serum chemistry parameters from baseline were observed. Few laboratory abnormalities were reported as treatment-emergent adverse events. Serious events included one event each of thrombocytopenia, hematuria, and hemolytic anemia, all unrelated to treatment. Abnormalities leading to treatment withdrawal included thrombocytopenia (one patient), increased hepatic enzymes (two patients), and blood creatine phosphokinase increased (one patient). No patients had Grade 3 anemia or Grade 3/4 thrombocytopenia; one patient had Grade 3 neutropenia (Week 100); two patients had Grade 3 eosinophilia (baseline visit); no eosinophil abnormalities were associated with clinically symptomatic events/permanent treatment discontinuation.
Dupilumab treatment of adults with moderate-to-severe AD up to 3 years showed no clinically meaningful changes in mean laboratory parameters, supporting continuous long-term use without laboratory monitoring.
CLINICALTRIALS.GOV IDENTIFIER: NCT01949311.
大多数用于中重度特应性皮炎（AD）的全身性药物可能会导致需要常规实验室监测的不良事件，增加患者负担，并可能降低治疗依从性。
评估接受度普利尤单抗治疗的中重度 AD 成人患者长达 3 年的临床实验室检查结果。
LIBERTY AD OLE（NCT01949311）是一项针对中重度 AD 成人患者的 3 期、多中心、开放标签扩展研究，患者接受度普利尤单抗 300mg 每周一次治疗。
2677 例患者接受治疗长达 3 年。从基线开始，平均血液学/血清化学参数无临床意义的变化。报告的少数实验室异常为治疗后出现的不良事件。严重事件包括血小板减少症、血尿和溶血性贫血各 1 例，均与治疗无关。导致停药的异常包括血小板减少症（1 例）、肝酶升高（2 例）和血肌酸磷酸激酶升高（1 例）。无患者发生 3 级贫血或 3/4 级血小板减少症；1 例患者发生 3 级中性粒细胞减少症（第 100 周）；2 例患者发生 3 级嗜酸性粒细胞增多症（基线就诊）；无嗜酸性粒细胞异常与有临床症状事件/永久性治疗停药相关。
度普利尤单抗治疗中重度 AD 成人长达 3 年，平均实验室参数无临床意义的变化，支持无需实验室监测的持续长期使用。
临床试验.gov 标识符：NCT01949311。
