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Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
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Related Experiment Video

Updated: Mar 14, 2026

Evaluating Therapeutic Interventions in the SHIP-deficient Mouse Model of Crohn Disease-like Ileitis and Fibrosis
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[Biosimilars in inflammatory bowel disease].

B Siegmund1, R Atreya2, B Bokemeyer3

  • 1Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm, Berlin.

Zeitschrift Fur Gastroenterologie
|October 7, 2016
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Summary
This summary is machine-generated.

The biosimilar CT-P13 demonstrates comparable efficacy and safety to Infliximab for inflammatory bowel diseases like Crohn's disease. Its introduction as a primary therapy is supported by clinical data, warranting continued safety monitoring.

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Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Patent expiry of Infliximab in 2013 led to the development of biosimilars.
  • CT-P13 is an Infliximab biosimilar approved for Crohn's disease and ulcerative colitis in adults and children.
  • Initial approval was based on randomized clinical studies demonstrating equivalence.

Purpose of the Study:

  • To evaluate the efficacy and safety of the Infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD).
  • To assess the long-term clinical experience and immunogenicity of CT-P13 post-approval.
  • To determine the justification for using CT-P13 as a primary therapy in IBD.

Main Methods:

  • Review of two randomized clinical studies comparing CT-P13 to Infliximab.
  • Analysis of post-approval clinical experience from multiple non-randomized studies.
  • Assessment of pharmacokinetic, efficacy, safety, and immunogenicity data.

Main Results:

  • Randomized studies indicated pharmacokinetic, efficacy, and safety equivalence between CT-P13 and Infliximab.
  • Subsequent clinical experience and non-randomized studies confirm comparable efficacy and immunogenicity.
  • CT-P13 shows a comparable safety profile to the reference Infliximab.

Conclusions:

  • The Infliximab biosimilar CT-P13 is a viable therapeutic option for inflammatory bowel disease.
  • Introduction of CT-P13 as primary therapy in IBD appears justified based on current evidence.
  • Ongoing monitoring of biosimilar safety, efficacy, and side effects is crucial.