Five-year Safety Data From OPUS, a European Observational Safety Registry for Adults With Ulcerative Colitis Treated With Originator Infliximab [Remicade®] or Conventional Therapy

Journal of Crohn's & Colitis
Julian PanesWalter Reinisch

Abstract

The Observational Postmarketing Ulcerative colitis Study [OPUS] was conducted to obtain the first long-term [5 years] safety data assessing treatment with originator infliximab versus conventional therapies in patients with ulcerative colitis [UC] in real-world clinical practice. The OPUS registry was a prospective, non-randomised, observational study that measured adverse events in nine prespecified categories of interest in UC patients whose treatment with either originator infliximab or conventional therapy [defined as initiation or dose-increase of corticosteroids and/or immunosuppressants] was determined by their treating physician. Data for 2239 patients were available: N = 1180 enrolled to conventional therapy [including N = 296 who switched to originator infliximab during follow-up] and N = 1059 enrolled to originator infliximab. Patients in the originator infliximab group, compared with the conventional therapy group, had more severe disease at baseline, based on partial Mayo score [PMS]: 46.0% of patients in the originator infliximab group had severe disease (PMS of 7-9 [out of 9]), compared with 30.5% in the conventional therapy group. In adjusted time-to-event analyses, enrolment into the originator infliximab group...Continue Reading

Associated Clinical Trials

References

Sep 1, 2008·Journal of Crohn's & Colitis·Marc FerrantePaul Rutgeerts
Aug 15, 2012·The American Journal of Gastroenterology·Gary R LichtensteinWilliam J Sandborn
Jan 8, 2014·The American Journal of Gastroenterology·Gary R LichtensteinWilliam J Sandborn
Apr 16, 2018·Gastroenterology·Julien KirchgesnerRosemary Dray-Spira

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Citations

May 23, 2020·Expert Opinion on Drug Safety·Ferdinando D'AmicoSilvio Danese
May 2, 2020·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Sang Joon LeeSeul Gi Lee
Sep 12, 2020·Journal of Crohn's & Colitis·Marie MullerLaurent Peyrin-Biroulet

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