Trial reportBritish journal of clinical pharmacology2015
Pharmacokinetics and concentration-effect relationship of adalimumab in rheumatoid arthritis.
Trial report in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 92 citations in OpenAlex.
- An Overview of Adalimumab Therapy for Ankylosing Spondylitis.Current rheumatology reviews · 2024Pooled it
- Pooled it
- Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events.International journal of colorectal disease · 2020Pooled it
- Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants.BMC pharmacology & toxicology · 2022Trial
- Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects.British journal of clinical pharmacology · 2021Trial
- Population Pharmacokinetics and Immunogenicity of Adalimumab in Adult Patients with Moderate-to-Severe Hidradenitis Suppurativa.Clinical pharmacokinetics · 2017Trial
- A possible influence of age on absorption and elimination of adalimumab in focal segmental glomerulosclerosis (FSGS).European journal of clinical pharmacology · 2016Trial
- Unlocking the Potential of Population Pharmacokinetic Models of Adalimumab in Patients with Crohn's Disease.Pharmaceutics · 2026Article
- Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study.Rheumatology and therapy · 2026Article
- Clinical Management of Antirheumatic Drug Exposure During Therapeutic Plasma Exchange.Clinical reviews in allergy & immunology · 2026Review
- Evaluation of a Therapeutic Drug Monitoring Strategy for Adalimumab in Psoriasis: A Prospective Pharmacokinetic-Pharmacodynamic Study.Clinical and translational science · 2026Observational
- Article
- Evaluating the Effectiveness of Escalating to Weekly Adalimumab Dosing for the Treatment of Noninfectious Uveitis: A Multicenter Study.Ophthalmology · 2026Article
- Association of serum adalimumab levels and immunogenicity with clinical response in non-infectious uveitis: a real-world cohort study.Frontiers in immunology · 2026Observational
- Article
- The Association Between Serum Drug Concentration and a Flare in Rheumatoid Arthritis Patients Tapering TNF Inhibitors.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress.Journal of biological engineering · 2025Review
- Comprehensive Parent-Metabolite PBPK/PD Modeling Insights Into Methotrexate Personalized Dosing Strategies in Patients With Rheumatoid Arthritis.CPT: pharmacometrics & systems pharmacology · 2025Article
- Assessing early therapeutic drug monitoring of adalimumab as a predictor of treatment efficacy and immunogenicity in rheumatic diseases: "early therapeutic drug monitoring of adalimumab".Clinical rheumatology · 2025Article
- Multiscale, mechanistic model of Rheumatoid Arthritis to enable decision making in late stage drug development.NPJ systems biology and applications · 2024Article
Corrections and comments
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Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThis study aimed at describing adalimumab pharmacokinetics (PK) and the concentration-effect relationship of adalimumab using pharmacokinetic-pharmacodynamic (PK-PD) modelling in patients with rheumatoid arthritis (RA).
methodsAdalimumab PK and PK-PD data were obtained from a multicentric observational study. Adalimumab (40 mg) was administered subcutaneously every other week, and its pharmacokinetics was described using a one-compartment model. The relationship between adalimumab concentration and C-reactive protein (CRP) concentration was described using an indirect response model with inhibition of CRP input, whereas the relationship between adalimumab concentration and disease activity score in 28 joints (DAS28) was described using a direct inhibition model. Dose regimens that included a loading dose of adalimumab were simulated.
resultsThirty patients treated for RA were analysed. The following pharmacokinetic and PK-PD parameters were estimated (interidividual coefficient of variation): apparent volume of distribution (Vd /F) = 10.8 l (92%); apparent clearance (CL/F) = 0.32 l day(-1) (17%); first-order absorption rate (ka ) = 0.28 day(-1) ; CRP input (kin ) = 22.0 mg l(-1) day(-1) (65%); adalimumab concentration leading to a 50% decrease in kin (C50 ) = 3.6 mg l(-1) (88%); baseline DAS28 (DAS0 ) = 5.5 mg l(-1) (11%); and adalimumab concentration leading to 50% decrease of DAS0 (IC50 ) = 11.0 mg l(-1) (71%). Simulations showed that a 160 mg loading dose should reduce the time to reach efficacy in terms of both CRP and DAS28 after the first injection.
conclusionsThis is the first study to describe adalimumab pharmacokinetics and the concentration-effect relationship in RA. A 160 mg loading dose may lead to an increased benefit from treatment in RA patients.
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