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Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Introduction
Inflammatory bowel disease, commonly known as IBD, refers to a collection of disorders that lead to persistent inflammation of the gastrointestinal tract. The two types of IBD are ulcerative colitis, which impacts the colon, and Crohn's disease, which can involve any part of the gastrointestinal segment.
Crohn's disease
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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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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Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational

Laixi Xue1,2, K van Bilsen3,4, M W J Schreurs2,5

  • 1Internal Medicine, Erasmus University Rotterdam, Rotterdam, Netherlands.

Frontiers in Medicine
|August 28, 2020
PubMed
Summary
This summary is machine-generated.

Switching from Remicade® to its biosimilar Remsima® showed no significant differences in patient outcomes for rare immune-mediated inflammatory diseases. However, some patients experienced disease relapse or adverse events, necessitating careful monitoring.

Keywords:
CTP 13Remicade®Remsima®anti-TNF-alphabiosimilarfucosylationinfliximabrare or orphan immune-mediated inflammatory diseases (IMIDs)

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Area of Science:

  • Immunology
  • Pharmacology
  • Rheumatology

Background:

  • Infliximab (Remicade®) has been a successful treatment for immune-mediated inflammatory diseases (IMIDs) since the late 1990s.
  • Infliximab biosimilars, such as Remsima®, are now available.
  • The interchangeability of originator infliximab and its biosimilars in rare IMIDs requires investigation.

Purpose of the Study:

  • To assess the interchangeability of Remicade® and Remsima® in patients with rare IMIDs.
  • To compare the efficacy and safety of Remicade® versus Remsima® after a switch.
  • To evaluate the impact of switching on quality of life and disease activity.

Main Methods:

  • A two-phased, prospective, open-label observational study.
  • Monitoring 48 patients with rare IMIDs switching from Remicade® to Remsima® over 2 years.
  • Assessing primary endpoints: quality of life and therapeutic efficacy (physician perception of disease activity [PPDA], patient self-reported outcomes [PSROs]).
  • Secondary outcomes: laboratory analysis, drug concentrations, and anti-drug antibodies.

Main Results:

  • No significant differences in PPDA, PSROs, clinical, or laboratory assessments between Remicade® and Remsima®.
  • Two patients developed de novo anti-drug antibodies.
  • Twelve patients (25%) experienced disease relapse or adverse events, leading to discontinuation in 10 cases.

Conclusions:

  • Switching from Remicade® to Remsima® did not show significant differences in patient-reported outcomes or physician-assessed disease activity.
  • A notable incidence of disease relapse or adverse events occurred in 12 out of 48 patients post-switch.
  • Careful consideration and monitoring are crucial when switching anti-TNF alpha biologics in rare IMIDs, especially sarcoidosis.