4.8 Letter

Ozanimod for Ulcerative Colitis

Journal

NEW ENGLAND JOURNAL OF MEDICINE
Volume 386, Issue 2, Pages 194-194

Publisher

MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMc2117224

Keywords

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Funding

  1. Pfizer
  2. AbbVie
  3. Janssen
  4. Merck Sharp and Dohme
  5. Takeda Pharmaceuticals
  6. Chiesi
  7. Galapagos
  8. Sofar

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The phase 3 trial of ozanimod for induction and maintenance therapy in patients with moderately to severely active ulcerative colitis raised concerns about the requirement for stable doses of oral aminosalicylates or glucocorticoids for eligible patients. Subsequent evaluation of treatment efficacy and safety measures should consider this aspect.
To the Editor: Regarding the phase 3 trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis (Sept. 30 issue)(1): there is an issue that we would like to raise. Eligible patients were required to have received stable doses of oral aminosalicylates or glucocorticoids (prednisone at a dose of <= 20 mg per day or budesonide) or both for at least 2 weeks before screening endoscopy and to continue receiving the same dose for the entire duration of the induction period. Although the proportion of patients in cohort 1 who received systemic glucocorticoids or . . .

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