ArticleAlimentary pharmacology & therapeutics2021
Population pharmacokinetics of subcutaneous infliximab CT-P13 in Crohn's disease and ulcerative colitis.
Article in Alimentary pharmacology & therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Meta-Analysis: Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease.Alimentary pharmacology & therapeutics · 2025Pooled it
- Infliximab Pharmacokinetics, Dosing, and Response in Hospitalized Patients with COVID-19 Pneumonia: A Secondary Analysis of a Multinational Randomized Clinical Trial (ACTIV-1 IM).Journal of clinical pharmacology · 2025Trial
- Pharmacokinetic comparison of subcutaneously administered CT-P13 (biosimilar of infliximab) via autoinjector and pre-filled syringe in healthy participants.Clinical and translational science · 2024Trial
- Perianal fistulizing Crohn's disease increases infliximab clearance and causes low infliximab exposure (ATLANTIC).Journal of Crohn's & colitis · 2026Article
- Population Pharmacokinetics of Subcutaneous Infliximab: A Real-World Study of Naïve and Switch Patients.Pharmaceutics · 2026Article
- Ulcerative colitis: signaling pathways, therapeutic targets and interventional strategies.Signal transduction and targeted therapy · 2026Review
- Therapeutic Drug Monitoring of the Subcutaneous Formulations of Infliximab and Vedolizumab-Current Knowledge and Future Directions.Journal of clinical medicine · 2026Review
- Article
- Simulated Dosing Regimens of Subcutaneous Infliximab in Adults and Children with Inflammatory Bowel Disease: Exploring Switch and Initiation Strategies.European journal of drug metabolism and pharmacokinetics · 2025Article
- Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study.Gut and liver · 2025Article
- Optimizing Infliximab Use in Real-World Inflammatory Bowel Disease: Insights from a Population Pharmacokinetic Model Integrating Intravenous and Subcutaneous Formulations.Gut and liver · 2025Article
- Pharmacokinetics-Based Design of Subcutaneous Controlled Release Systems for Biologics.CPT: pharmacometrics & systems pharmacology · 2025Article
- Role of Mirikizumab in the Treatment of Inflammatory Bowel Disease-From Bench to Bedside.Journal of clinical medicine · 2025Review
- Infliximab in Inflammatory Bowel Disease: Leveraging Physiologically Based Pharmacokinetic Modeling in the Clinical Context.Biomedicines · 2024Article
- Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure.Gut and liver · 2024Article
- Integrating Nanotechnological Advancements of Disease-Modifying Anti-Rheumatic Drugs into Rheumatoid Arthritis Management.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics.Journal of clinical medicine · 2023Review
- Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and RemicadeAdvances in therapy · 2023Article
- Therapeutic Drug Monitoring of Subcutaneous Infliximab in Inflammatory Bowel Disease-Understanding Pharmacokinetics and Exposure Response Relationships in a New Era of Subcutaneous Biologics.Journal of clinical medicine · 2022Review
- Ulcerative Colitis and Acute Severe Ulcerative Colitis Patients Are Overlooked in Infliximab Population Pharmacokinetic Models: Results from a Comprehensive Review.Pharmaceutics · 2022Review
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInfliximab is a chimeric monoclonal antibody against tumour necrosis factor-alpha for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Recently, a subcutaneous formulation of CT-P13, an infliximab biosimilar, was approved for clinical use.
aimsTo characterise CT-P13 pharmacokinetics (PK) and its clinically relevant determinants after subcutaneous administration through population PK modelling.
methodsData from a two-part Phase I study with intravenous (5 mg/kg) and variable maintenance subcutaneous dosing of CT-P13 with frequent PK sampling in patients with CD or UC were used. Population PK analysis was conducted by non-linear mixed effects modelling. Covariates affecting PK parameters were chosen based on their clinical relevance (effect size of ≥20%) using a full fixed-effect modelling approach.
resultsCT-P13 PK was described by a two-compartment model with linear elimination. The half-life in a typical 70 kg patient with serum albumin of 44 g/L was 10.8 days. The typical value for clearance was 0.355 L/d, absorption constant 0.273/d, bioavailability 79.1%, central volume of distribution 3.10 L and peripheral volume of distribution 1.93 L. Clinically relevant covariates affecting clearance were body weight (+43.2% from 70 to 120 kg), the presence of anti-drug antibodies (+39%) and serum albumin concentration (+30.1% from 44 to 32 g/L). Simulated drug exposure was comparable between routes of administration for patients weighing 50 or 70 kg, but lower with subcutaneous dosing in patients weighing 120 kg.
conclusionsThis first population PK model for subcutaneous CT-P13 supports fixed subcutaneous maintenance dosing, although heavy patients had lower cumulative drug exposure.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.