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

doi:10.12092/j.issn.1009-2501.2026.07.008

Abstract

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

CLC Number:

R758.63
R969

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.

Figures/Tables 2

References 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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