Trial reportClinical drug investigation2023
Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial.
Trial report in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02883452 (An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Meta-Analysis: Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease.Alimentary pharmacology & therapeutics · 2025Pooled it
- Comparing Outcomes With Subcutaneous Infliximab (CT-P13 SC) by Baseline Immunosuppressant Use: A Post Hoc Analysis of the LIBERTY-CD and LIBERTY-UC Studies.Inflammatory bowel diseases · 2025Trial
- Practical guidelines on medical management of adults with moderate-to-severe inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026Article
- Persistence and safety of subcutaneous infliximab up to 1 year after switching from intravenous infliximab in pediatric inflammatory bowel disease: a multicenter real-world cohort study.Inflammatory bowel diseases · 2026Article
- Is it time to move away from legacy inflammatory bowel disease drugs?Singapore medical journal · 2026Article
- Therapeutic Drug Monitoring of the Subcutaneous Formulations of Infliximab and Vedolizumab-Current Knowledge and Future Directions.Journal of clinical medicine · 2026Review
- Subcutaneous infliximab in inflammatory bowel disease: bridging the gap between theory and practice.Crohn's & colitis 360 · 2026Article
- Therapeutic Drug Monitoring in Special Circumstances in Inflammatory Bowel Disease.Journal of clinical medicine · 2025Review
- 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
- Insights into the Molecular Mechanisms and Novel Therapeutic Strategies of Stenosis Fibrosis in Crohn's Disease.Biomedicines · 2025Review
- Understanding the therapeutic toolkit for inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2025Review
- A Comparison of Intravenous Infliximab Versus Subcutaneous Infliximab on Remission Rates, Safety, Costs, Patient Preferences in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.Gastro hep advances · 2025Article
- Combination treatment of inflammatory bowel disease: Present status and future perspectives.World journal of gastroenterology · 2024Article
- Raising the bar in ulcerative colitis management.Therapeutic advances in gastroenterology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 8 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveWhether benefits and risks of intravenous (IV) infliximab combotherapy with immunosuppressants versus infliximab monotherapy apply to subcutaneous (SC) infliximab is unknown. This post hoc analysis of a pivotal randomised CT-P13 SC 1.6 trial aimed to compare SC infliximab monotherapy with combotherapy in inflammatory bowel disease (IBD).
methodsBiologic-naïve patients with active Crohn's disease or ulcerative colitis received CT-P13 IV 5 mg/kg at Week (W) 0 and 2 (dose-loading phase). At W6, patients were randomised (1:1) to receive CT-P13 SC 120 or 240 mg (patients < 80 or ≥ 80 kg) every 2 weeks until W54 (maintenance phase), or to continue CT-P13 IV every 8 weeks until switching to CT-P13 SC from W30. The primary endpoint-non-inferiority of trough serum concentrations-was assessed at W22. We report a post hoc analysis comparing pharmacokinetic, efficacy, safety and immunogenicity outcomes up to W54 for patients randomised to CT-P13 SC, stratified by concomitant immunosuppressant use.
resultsSixty-six patients were randomised to CT-P13 SC (37 monotherapy, 29 combotherapy). At W54, there were no significant differences in the proportions of patients achieving target exposure (5 µg/mL; 96.6% monotherapy vs 95.8% combotherapy; p > 0.999) or meeting efficacy or biomarker outcomes including clinical remission (62.9% vs 74.1%; p = 0.418). Monotherapy and combotherapy groups had comparable immunogenicity (anti-drug antibodies [ADAs]: 65.5% vs 48.0% [p = 0.271], neutralising antibodies [in ADA-positive patients]: 10.5% vs 16.7% [p = 0.630], respectively).
conclusionsPharmacokinetics, efficacy and immunogenicity were potentially comparable between SC infliximab monotherapy and combotherapy in biologic-naïve IBD patients.
trial registrationClinicalTrials.gov: NCT02883452.
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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.