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Vedolizumab is effective and safe in real-life treatment of inflammatory bowel diseases outpatients: A multicenter, observational study in primary inflammatory bowel disease centers

      Highlights

      • Vedolizumab (VDZ) is currently a chance to treat Inflammatory Bowel Diseases (IBD).
      • No data in using VDZ in primary gastroenterology centers were available until now.
      • VDZ reached significant remission in IBD patients, with low adverse events rate.
      • Significant percentage of mucosal healing and clinical response were also reached.

      Abstract

      Background

      Italian data currently available in managing ulcerative colitis (UC) and Crohn's disease (CD) patients with vedolizumab (VDZ) are coming just from secondary and tertiary centers. The present study aimed to assess the real-life efficacy and safety of VDZ to achieve remission in inflammatory bowel diseases (IBD) outpatients in primary gastroenterology centers.

      Methods

      Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), and steroid discontinuation.

      Results

      One hundred and thirty-six pts. were enrolled (91 UC and 45 CD pts). During an 18-month median follow-up, clinical remission was present in 63 (46.3%) pts.: in particular, it occurred in 48 (52.7%) patients in UC group and in 15 (33.3%) patients in CD group (p = 0.003).
      more in UC group. Fecal calprotectin ≥400 μg/g and presence of comorbidities were factors significantly related to the failure of remission in UC and CD, respectively.
      Ten (7.3%) cases of adverse events were recorded (2 required suspension of treatment).
      Clinical response was present in 105 (72.2%) pts.: 71 (78.0%) in UC and 34 (75.5%) in CD group. MH occurred in 47 (62.7%) UC and in 9 (50.0%) CD patients. Steroids discontinuation occurred in 92 (67.6%) pts.; 61 (67.0%) UC and 31 (68.9%) CD pts.

      Conclusion

      VDZ is effective and safe in IBD outpatients, especially in UC patients.

      Keywords

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