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• W2978463335 abstract "Introduction: Vedolizumab, an alpha 4 beta 7 integrin antagonist, was approved by the FDA for treatment of Crohn's disease (CD) in May 2014 on the efficacy and safety demonstrated in a large randomized controlled clinical trial (NEJM 2013; 369:711-721). However, less than one third of patients evaluated in routine clinical practice would qualify for enrollment in large RCT of biologics in inflammatory bowel disease (Clin Gastroenterol Hepatol. 2012 Sep;10(9):1002-7). Therefore, we evaluated the safety and efficacy of vedolizumab for the treatment of CD in a real world inflammatory bowel disease clinical practice. Methods: Patients with CD who received vedolizumab for more than 14 weeks were identified through a prospective vedolizumab patient registry. The cohort was evaluated based on clinical assessment and laboratory findings. Results: Between August 2014 and December 2015 26 patients with Crohn's disease started vedolizumab and were followed for at least 14 weeks (54% male; mean age, 47 +/- 15.1 years). The patients exhibited a significant decrease in HBAI, from 9.9 at baseline, 7.8 after 14 weeks, and 7.0 after 6 months (P < 0.001 and P=0.01 respectively). Thirty-six percent of patients were completely off steroids after 4 weeks and 63% were completely off steroids after 6 months. Clinical response, defined as improvement in disease severity as measured by HBAI, was achieved in 36% (8/22) and 50% (8/16) of patients after 14 weeks and 6 months of vedolizumab treatment, respectively. Clinical remission, defined as HBAI < 5, was achieved in 18% (4/22) and 31% (5/16) of patients after 14 weeks and 6 months of vedolizumab treatment, respectively (Figure 1). Additionally, C-reactive protein levels declined at 14 weeks and at 6 months (P < 0.01) (Figure 2). The most common side effect recorded was arthralgia, affecting 15% of participants. Notable serious adverse events were hospitalization (2/26) and colectomy (1/26). Eighty-eight percent of patients followed for at least 6 months remained on vedolizumab.Figure 1Figure 2Conclusion: In this real world CD cohort, vedolizumab was effective and had a favorable safety profile. Patients with longer treatment duration were more likely to have clinical improvement. Serum CRP levels decreased in aggregate during treatment, mirroring clinical improvement. Serious adverse events were uncommon and may reflect a refractory disease state rather than a drug reaction." @default.
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• W2978463335 date "2016-10-01" @default.
• W2978463335 modified "2023-09-27" @default.
• W2978463335 title "Vedolizumab for the Treatment of Crohnʼs Disease: Experience in an Inflammatory Bowel Disease Clinical Practice" @default.
• W2978463335 doi "https://doi.org/10.14309/00000434-201610001-00600" @default.
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