SynthesisDigestive diseases and sciences2020
Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease.
Synthesis in Digestive diseases and sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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
18 citing papers in PubMed, 33 citations in OpenAlex.
- Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease.Intestinal research · 2026Article
- Outcomes of a mandatory non-medical switch of infliximab to a biosimilar for inflammatory bowel disease in British Columbia, Canada.Journal of the Canadian Association of Gastroenterology · 2024Article
- Benefits of Biosimilars in the Management of Patients with Inflammatory Bowel Disease: An International Survey.Journal of clinical medicine · 2024Article
- Does the introduction of an infliximab biosimilar always result in savings for hospitals? A descriptive study using real-world data.Health economics review · 2024Article
- An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024Article
- Treatment persistence and switching patterns of ABP 501 in European patients with inflammatory bowel disease.Therapeutic advances in gastroenterology · 2024Article
- Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus.Journal of clinical medicine · 2023Article
- PERFUSE: a French non-interventional study of patients with inflammatory bowel disease receiving infliximab biosimilar SB2: a 12-month analysis.Therapeutic advances in gastroenterology · 2023Article
- Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study.Gastroenterology research and practice · 2023Article
- Exploring the Reasons Behind the Substantial Discontinuation Rate Among Patients Taking CT-P13 in a Large Tertiary Hospital in Western Switzerland: A Retrospective Cohort Study Using Routinely Collected Medical Data.Drugs - real world outcomes · 2022Article
- Multiple Switches From the Originator Infliximab to Biosimilars Is Effective and Safe in Inflammatory Bowel Disease: A Prospective Multicenter Cohort Study.Inflammatory bowel diseases · 2022Article
- Biosimilars in Pediatric IBD: Updated Considerations for Disease Management.Biologics : targets & therapy · 2022Review
- Article
- The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics.Crohn's & colitis 360 · 2021Review
- The Great Debate With IBD Biosimilars: Con: Biosimilars Should Not Be Routinely Used as a First Line Biologic and Not Switched From Reference Biologics.Crohn's & colitis 360 · 2021Review
- The Efficacy and Safety of Switching From Originator Infliximab to Single or Double Switch Biosimilar Among a Nationwide Cohort of Inflammatory Bowel Disease Patients.Crohn's & colitis 360 · 2021Article
- Non-medical Switching of Infliximab to CT-P13 Biosimilar in Inflammatory Bowel Disease: A Focus on the Definition of "Non-medical Switch".Digestive diseases and sciences · 2020Article
- Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?Digestive diseases and sciences · 2020Article
Corrections and comments
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Authors and funding
3 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsBiosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn's disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13.
methodsA literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed to contextualize data relevance.
resultsA total of 49 reports (3 randomized controlled trials, 40 observational trials, and 1 case series) were included. Most studies revealed no efficacy, safety, or immunogenicity concerns with non-medical switch. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of appropriate controls; and scarcity of research on biosimilar switch long-term effects.
conclusionsThe majority of studies suggested non-medical switch is safe. However, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable IBD patients to biosimilars.
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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.