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Drugs for Treatment of Ulcerative Colitis in IBD

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Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
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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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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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Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
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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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Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis.

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  • 1From the University of California San Diego, La Jolla (W.J.S.); Western University, London, ON, Canada (B.G.F.); the Inflammatory Bowel Disease Center, Academic Medical Center, Amsterdam (G.D.); the Center for Crohn's Disease and Ulcerative Colitis, Atlanta Gastroenterology Associates, Atlanta (D.C.W.); the Division of Gastroenterology, University Hospital Medical Center Bežanijska Kosa, Belgrade, Serbia (I.J.); the Feinberg School of Medicine, Chicago (S.B.H.); APC Microbiome Ireland, College of Medicine and Health, University College Cork, Cork, Ireland (S.G.); Bristol Myers Squibb, Princeton, NJ (A.P., S.Y.H., J.H.L., L.C., D.C., K.U.); the Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (J.-F.C.); Yale School of Medicine, New Haven, and the Veterans Affairs Connecticut Healthcare System, West Haven - both in Connecticut (L.L.); and IRCCS Humanitas Research Hospital and University Vita-Salute San Raffaele, Milan (S.D.).

The New England Journal of Medicine
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PubMed
Summary

Ozanimod demonstrated superior efficacy compared to placebo for inducing and maintaining remission in ulcerative colitis patients. This selective sphingosine-1-phosphate receptor modulator offers a promising treatment option for inflammatory bowel disease.

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Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) requiring effective therapeutic options.
  • Ozanimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, has been investigated for its immunomodulatory effects in IBD.
  • Current treatments for moderate to severe UC have limitations, necessitating novel therapeutic strategies.

Purpose of the Study:

  • To evaluate the efficacy and safety of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis.
  • To determine the rates of clinical remission and response with ozanimod compared to placebo.
  • To assess key secondary clinical, endoscopic, and histologic endpoints, as well as safety parameters.

Main Methods:

  • A phase 3, multicenter, randomized, double-blind, placebo-controlled trial was conducted.
  • Patients received oral ozanimod (1 mg daily) or placebo for a 10-week induction period.
  • Responders proceeded to a 52-week maintenance period, receiving either ozanimod or placebo in a double-blind manner.

Main Results:

  • Ozanimod significantly increased clinical remission rates during both induction (18.4% vs. 6.0%) and maintenance (37.0% vs. 18.5%) compared to placebo (P<0.001 for both).
  • Clinical response rates were also significantly higher with ozanimod during induction (47.8% vs. 25.9%) and maintenance (60.0% vs. 41.0%).
  • All key secondary endpoints favored ozanimod; infections were slightly more common during maintenance, and elevated liver enzymes were more frequent with ozanimod.

Conclusions:

  • Ozanimod is effective for both induction and maintenance therapy in patients with moderate to severe ulcerative colitis.
  • The drug demonstrated significant improvements across primary and secondary endpoints compared to placebo.
  • While generally well-tolerated, monitoring for infections and liver enzymes is advised.