阿达木单抗治疗中重度银屑病的PK/PD特征与治疗药物监测应用

doi:10.12092/j.issn.1009-2501.2026.07.008

中国临床药理学与治疗学 ›› 2026, Vol. 31 ›› Issue (7): 921-927.doi: 10.12092/j.issn.1009-2501.2026.07.008

阿达木单抗治疗中重度银屑病的PK/PD特征与治疗药物监测应用

杨建鑫¹^,²(), 俞蕴莉¹^,²^,*()

1. 苏州大学附属第二医院药学部，苏州 215004，江苏
2. 苏州市核素治疗与核应急药物临床转化与应用重点实验室，苏州 215004，江苏

收稿日期:2025-05-23 修回日期:2025-06-24 出版日期:2026-07-26 发布日期:2026-08-04
通讯作者: 俞蕴莉 E-mail:yangjx897@163.com;haoyyl0902@163.com
作者简介:杨建鑫，女，博士，助理研究员，研究方向：临床药物代谢动力学。E-mail： yangjx897@163.com
基金资助:
国家自然科学基金面上项目（82173879）；苏州市姑苏卫生人才青年拔尖人才项目（GSWS2022040）；苏州大学附属第二医院学科建设托举项目（XKTJ- XK202406）；苏州大学附属第二医院科研预研基金（SDFEYBS2308）；苏州市重点实验室建设项目（SZS2025012）

Pharmacokinetic/pharmacodynamic characteristics of adalimumab in moderate-to-severe psoriasis and its therapeutic drug monitoring applications

Jianxin YANG¹^,²(), Yunli YU¹^,²^,*()

1. Department of Pharmacy, The Second Affiliated Hospital of Soochow University, Suzhou 215004, Jiangsu, China
2. Suzhou Key Laboratory of Clinical Translation and Application of Radionuclide Therapy and Nuclear Emergency Drugs, Suzhou 215004, Jiangsu, China

Received:2025-05-23 Revised:2025-06-24 Online:2026-07-26 Published:2026-08-04
Contact: Yunli YU E-mail:yangjx897@163.com;haoyyl0902@163.com

摘要/Abstract

摘要：

阿达木单抗作为全球首个获批上市的抗肿瘤坏死因子 α（tumor necrosis factor-α，TNF-α）单克隆抗体，已成为中重度银屑病的一线治疗选择。然而，该药物在银屑病患者群体中的药代动力学/药效动力学（pharmacokinetics/pharmacodynamics，PK/PD）特征尚未完全阐明。本文比较系统地综述了阿达木单抗在中重度银屑病治疗中的PK及其PD特性，重点探讨了抗药抗体形成和体质量等患者特异性因素对药物暴露的影响，并分析了治疗药物监测在银屑病治疗中的临床应用价值及优化策略，强调了建立银屑病特异性药物浓度-疗效关系模型和治疗窗的重要价值，以期为今后开展大样本临床研究提供明确方向，对银屑病个体化精准治疗策略的制定和实施提供指导。

关键词: 阿达木单抗, 银屑病, PK/PD, 治疗药物监测

Abstract:

As the first anti-TNF-α monoclonal antibody approved for clinical use worldwide, adalimumab has become a first-line treatment for moderate-to-severe psoriasis. However, this drug's pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in psoriasis patients have not yet been fully elucidated. This article systematically reviews the PK and PD properties of adalimumab in the treatment of moderate-to-severe psoriasis, with a focus on the impact of patient-specific factors such as anti-drug antibody formation and body weight on drug exposure. Additionally, it analyzes the clinical application value and optimization strategies of therapeutic drug monitoring (TDM) in psoriasis treatment. This review emphasizes the importance of establishing psoriasis-specific drug concentration-efficacy relationship models and therapeutic windows, aiming to provide clear directions for future large-scale clinical studies and to guide the development and implementation of personalized precision treatment strategies for psoriasis.

Key words: adalimumab, psoriasis, PK/PD, therapeutic drug monitoring

中图分类号:

R758.63
R969

杨建鑫, 俞蕴莉. 阿达木单抗治疗中重度银屑病的PK/PD特征与治疗药物监测应用[J]. 中国临床药理学与治疗学, 2026, 31(7): 921-927.

Jianxin YANG, Yunli YU. Pharmacokinetic/pharmacodynamic characteristics of adalimumab in moderate-to-severe psoriasis and its therapeutic drug monitoring applications[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(7): 921-927.

图/表 2

参考文献 37

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Parameter	Value	Source of variability
Dosage regimen	40 mg SC q2w	Body weight, injection site
Bioavailability	64%	Variability in subcutaneous absorption
T_max	5-7 d	Local blood flow
C_min	5 μg/mL	ADA, disease status
V_d	5-6 L	Body fluid distribution
t_1/2	approx. 14 d	Metabolic enzyme activity, target-mediated drug disposition

Parameter	Value	Source of variability
Dosage regimen	40 mg SC q2w	Body weight, injection site
Bioavailability	64%	Variability in subcutaneous absorption
T_max	5-7 d	Local blood flow
C_min	5 μg/mL	ADA, disease status
V_d	5-6 L	Body fluid distribution
t_1/2	approx. 14 d	Metabolic enzyme activity, target-mediated drug disposition

Category	Factor	Impact on PK/PD	Outcome	Clinical implications
Immunogenicity	ADA	- Accelerates drug clearance - Reduces serum concentration - Negative correlation with efficacy	- ADA incidence: 8.8%-44.8%^[23] - Clearance ↑2-fold in ADA+ patients ^[20] - Strong negative correlation between drug level and ADA ^[16]	ADA monitoring recommended; consider dose adjustment or combination with immunosuppressants
Immunogenicity	HLA-DQA1*05 allele	Increases ADA risk	Carriers show ↑ADA risk ^[24]	Genetic screening may identify high-risk populations
Concomitant Drugs	Methotrexate	- Reduces ADA formation - Increases serum concentration	- ADA rate: 22.6% (combination) vs. 60.0% (monotherapy) ^[25] - Trough: 6.8 mg/L vs. 5.9 mg/L ^[25]	Recommended combination therapy for optimal efficacy
Concomitant Drugs	Corticosteroids	Improves early efficacy	↑PASI 75 response rate at week 4 (40.7% vs. 32.4%) ^[26]	Suitable for rapid symptom control
Covariates	Body weight	Weight↑ → Clearance↑ → Higher dose required	Population PK models confirm weight as major covariate for clearance ^[12,22]	Weight-based dosing (especially in children/obese patients)
Covariates	Age/gender/ disease severity	Inconsistent effects requiring individualized evaluation	Significant variability across studies ^[12,21,22]	Comprehensive clinical judgment needed
Other Factors	Inflammatory markers	CRP↑ or albumin↓ → Clearance↑	Pediatric Crohn's: High CRP/low albumin → ↑clearance ^[27]	Monitor inflammatory status to predict PK changes
Other Factors	Rheumatoid factor (RF)	RF↑ → Adalimumab AUC↓	RA patients: High RF associated with ↓AUC (no effect on Fc-free drugs) ^[28]	Higher doses may be needed in RF+ patients

Category	Factor	Impact on PK/PD	Outcome	Clinical implications
Immunogenicity	ADA	- Accelerates drug clearance - Reduces serum concentration - Negative correlation with efficacy	- ADA incidence: 8.8%-44.8%^[23] - Clearance ↑2-fold in ADA+ patients ^[20] - Strong negative correlation between drug level and ADA ^[16]	ADA monitoring recommended; consider dose adjustment or combination with immunosuppressants
Immunogenicity	HLA-DQA1*05 allele	Increases ADA risk	Carriers show ↑ADA risk ^[24]	Genetic screening may identify high-risk populations
Concomitant Drugs	Methotrexate	- Reduces ADA formation - Increases serum concentration	- ADA rate: 22.6% (combination) vs. 60.0% (monotherapy) ^[25] - Trough: 6.8 mg/L vs. 5.9 mg/L ^[25]	Recommended combination therapy for optimal efficacy
Concomitant Drugs	Corticosteroids	Improves early efficacy	↑PASI 75 response rate at week 4 (40.7% vs. 32.4%) ^[26]	Suitable for rapid symptom control
Covariates	Body weight	Weight↑ → Clearance↑ → Higher dose required	Population PK models confirm weight as major covariate for clearance ^[12,22]	Weight-based dosing (especially in children/obese patients)
Covariates	Age/gender/ disease severity	Inconsistent effects requiring individualized evaluation	Significant variability across studies ^[12,21,22]	Comprehensive clinical judgment needed
Other Factors	Inflammatory markers	CRP↑ or albumin↓ → Clearance↑	Pediatric Crohn's: High CRP/low albumin → ↑clearance ^[27]	Monitor inflammatory status to predict PK changes
Other Factors	Rheumatoid factor (RF)	RF↑ → Adalimumab AUC↓	RA patients: High RF associated with ↓AUC (no effect on Fc-free drugs) ^[28]	Higher doses may be needed in RF+ patients

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阿达木单抗治疗中重度银屑病的PK/PD特征与治疗药物监测应用

Pharmacokinetic/pharmacodynamic characteristics of adalimumab in moderate-to-severe psoriasis and its therapeutic drug monitoring applications

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