Observational studyEuropean journal of gastroenterology & hepatology2017
Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results.
Observational study in European journal of gastroenterology & hepatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 6 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
17 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- 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
- 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
- Long-term effectiveness and pharmacokinetics of the infliximab biosimilar CT-P13 after switching from the originator during the treatment of inflammatory bowel disease.European journal of hospital pharmacy : science and practice · 2022Observational
- Real-world data on the infliximab biosimilar CT-P13 (RemsimaWorld journal of clinical cases · 2021Article
- 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
- The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis.Alimentary pharmacology & therapeutics · 2019Article
- Implementation of CT-P13 via a Managed Switch Programme in Crohn's Disease: 12-Month Real-World Outcomes.Digestive diseases and sciences · 2019Article
- Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data.Therapeutic advances in gastroenterology · 2019Article
- Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective.Therapeutic advances in gastroenterology · 2019Review
- Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease.World journal of gastroenterology · 2018Observational
- Biosimilars in paediatric inflammatory bowel disease.World journal of gastroenterology · 2018Review
- Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017.Current treatment options in gastroenterology · 2018Review
- Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease.Therapeutic advances in gastroenterology · 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
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBiological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. MATERIALS AND
methodsThis was a prospective single-center observational study in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study.
resultsA total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey-Bradshaw score showed a significant change at 12 months (P=0.007) but no significant change was observed in median CRP at this timepoint (P=0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P=0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients.
conclusionSwitching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.
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.