ArticleDigestive diseases and sciences2015
Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series.
Article in Digestive diseases and sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 10 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
38 citing papers in PubMed, 10 syntheses or guidelines pooled it, 122 citations in OpenAlex.
- The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: a systematic review and meta-analysis.BMC gastroenterology · 2024Pooled it
- Discontinuation and Switchback After Non-Medical Switching from Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies from 2012 to 2018.Advances in therapy · 2022Pooled it
- Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease.Digestive diseases and sciences · 2020Pooled it
- An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease.International journal of colorectal disease · 2019Pooled it
- Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Alimentary pharmacology & therapeutics · 2019Pooled it
- The Biosimilar Nocebo Effect? A Systematic Review of Double-Blinded Versus Open-Label Studies.Journal of managed care & specialty pharmacy · 2018Pooled it
- Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to Their Biosimilars: Systematic Review of Randomized Controlled Trials and Real-World Studies.Advances in therapy · 2018Pooled it
- Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes.Drugs · 2018Pooled it
- Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Article
- Observational
- DCLK1 autoinhibition and activation in tumorigenesis.Innovation (Cambridge (Mass.)) · 2022Article
- Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases.Intestinal research · 2020Review
- Hemolytic anemia after switching from infliximab originator to biosimilar CT-P13 in a patient with inflammatory bowel disease: A case report.Clinical case reports · 2019Article
- Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective.Therapeutic advances in gastroenterology · 2019Review
- Positioning of old and new biologicals and small molecules in the treatment of inflammatory bowel diseases.World journal of gastroenterology · 2018Review
- Degree of prescriber's knowledge about variability in biological drugs "innovators" in manufacturing process.European journal of clinical pharmacology · 2018Article
- Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017.Current treatment options in gastroenterology · 2018Review
- A descriptive analysis of real-world treatment patterns of innovator (RemicadeBiologics : targets & therapy · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area.
aimWe aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center.
methodsSeventeen subjects diagnosed with Crohn's disease (CD, n = 8) or ulcerative colitis (UC, n = 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients' characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction.
resultsMale-female ratio was 1.8. Mean age was 35.4 years (range 15-57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period.
conclusionsCT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.
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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.