ArticleAlimentary pharmacology & therapeutics2019
The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis.
Article in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- SYSTEMATIC REVIEW AND BRAZILIAN EXPERT CONSENSUS ON THE USE OF BIOSIMILARS IN INFLAMMATORY BOWEL DISEASE: BRAZILIAN ORGANIZATION FOR CROHN'S AND COLITIS.Arquivos de gastroenterologia · 2026Pooled it
- Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.Current drug research reviews · 2025Pooled it
- Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review.Journal of managed care & specialty pharmacy · 2024Pooled it
- Systematic review: societal cost of illness of inflammatory bowel disease is increasing due to biologics and varies between continents.Alimentary pharmacology & therapeutics · 2021Pooled it
- Computational definition of medical exclusion and feasibility of excluding people not eligible for French population-based colorectal cancer screening from the French medico-administrative database.BMC medical informatics and decision making · 2025Review
- Effectiveness and safety of biosimilars in pediatric inflammatory bowel diseases: an observational longitudinal study on the French National Health Data System.World journal of pediatrics : WJP · 2025Observational
- Safety outcomes in 2132 Danish patients with inflammatory arthritis treated with biosimilar infliximab (GP1111) in routine care.Therapeutic advances in musculoskeletal disease · 2025Article
- Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data.BMC rheumatology · 2024Article
- Observational
- Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease.Frontiers in immunology · 2024Article
- TNF-alpha inhibitors biosimilar use in France: a nationwide population-based study using the French National Health Data System.Scientific reports · 2022Article
- Efficacy and safety of biosimilar versus originator infliximab in patients with inflammatory bowel disease: A real-world cohort analysis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2022Article
- How to Choose the Biologic Therapy in a Bio-naïve Patient with Inflammatory Bowel Disease.Journal of clinical medicine · 2022Review
- Does Similarity Breed Contempt? A Review of the Use of Biosimilars in Inflammatory Bowel Disease.Digestive diseases and sciences · 2021Review
- Retrospective Cohort Study Comparing Infliximab-dyyb and Infliximab in Biologic-Naive Patients With Inflammatory Bowel Disease in the United States.Crohn's & colitis 360 · 2021Article
- Clinical Practice of Adalimumab and Infliximab Biosimilar Treatment in Adult Patients With Crohn's Disease.Inflammatory bowel diseases · 2021Article
- Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab.Pharmacology research & perspectives · 2020Article
- The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases.Drugs · 2020Review
- The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis.Alimentary pharmacology & therapeutics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundCT-P13, a biosimilar of the reference product infliximab, has been approved for the treatment of ulcerative colitis on the basis of the results of trials conducted in patients with spondyloarthritis and rheumatoid arthritis.
aimTo compare the effectiveness and safety of CT-P13 and the reference product in infliximab-naive patients with ulcerative colitis
methodsA comparative real-life equivalence cohort study was conducted using the French nationwide health administrative database. Infliximab-naive patients with ulcerative colitis over 15 years of age who started infliximab with no other indications for infliximab were included. The primary outcome was a composite endpoint (death, ulcerative colitis-related surgery, all-cause hospitalisation and reimbursement for other biologics). Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 vs the reference product, in a multivariable marginal Cox model situated within prespecified margins of (0.80-1.25).
resultsA total of 3112 patients were included between 1 January 2015 and 30 June 2017: 1434 received the reference product, 1678 received CT-P13. Overall, 710 patients in the reference product group and 743 patients in the CT-P13 group met the composite endpoint. In multivariable analysis of the primary outcome, CT-P13 was equivalent to the reference product (HR 1.04; 95% CI: 0.94-1.15). The number of serious infections was lower in the CT-P13 group (HR 0.65; 95% CI: 0.48-0.88). There was no difference in the incidence of solid or haematologic malignancy (HR 0.81; 95% CI: 0.41-1.60).
conclusionsThe effectiveness of CT-P13 is equivalent and the risk of serious infections could be lower than that of the reference product for infliximab-naive patients with ulcerative colitis.
Indexed as
Identifiers
What OpenQuestion holds
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.