SynthesisArquivos de gastroenterologia2026
SYSTEMATIC REVIEW AND BRAZILIAN EXPERT CONSENSUS ON THE USE OF BIOSIMILARS IN INFLAMMATORY BOWEL DISEASE: BRAZILIAN ORGANIZATION FOR CROHN'S AND COLITIS.
Synthesis in Arquivos de gastroenterologia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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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.
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Authors and funding
22 authors.
Funding
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Abstract
backgroundBiologics improve outcomes in inflammatory bowel disease, but high costs restrict access and strain healthcare resources. Biosimilars lower costs, expand access, and support sustainable IBD care.
objectiveProvide clear, evidence-based answers on biosimilar use in IBD across clinical, therapeutic, and economic domains to guide safe implementation and informed decision-making.
methodsGEDIIB conducted a PICO-structured systematic review across multiple databases and trial registries. We extracted clinically relevant outcomes and performed systematic review. We assessed risk of bias with RoB 2.0 and ROBINS-I and graded certainty using GRADE. A structured Delphi process with two voting rounds and external validation finalized recommendations, with consensus predefined at 85 percent or higher.
resultsAnti-TNF biosimilars and originator biologics have similar efficacy, safety, immunogenicity, treatment persistence, and mucosal healing in biologic-naive patients and after switching, with no clinically meaningful differences in adverse events, loss of response, or discontinuation. Data on multiple switches do not indicate harm, though evidence remains limited. Pediatric studies suggest similar profiles, with lower precision. Economic evaluations show substantial cost savings and improved access, supporting the sustainability of the health system.
conclusionBiosimilars represent a viable, safe, and cost-effective option for IBD management. We recommend structured switching strategies, clear communication with patients, and continuous clinical monitoring. Additional robust studies should strengthen evidence in specific populations and clinical scenarios.
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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.