Real-world efficacy and safety of vedolizumab among patients with inflammatory bowel disease: A single tertiary medical center experience in Central Taiwan

The incidence of IBD is increasing in Eastern countries. The anti-TNF-alpha biological agents are available in patients with severely active IBD. Recently, the vedolizumab was approved by Taiwan Food and Drug Administration (TFDA). The efficacy and safety of vedolizumab in real-world practice for Asia regions is uncertain. Our primary endpoint is to evaluate the efficacy of vedolizumab for TNF-alpha exposure and naive patients during induction phase. The secondary endpoints are adverse events, infection, and emergent surgery during induction. We conducted a retrospective observational cohort study from November 2017 to April 2019 in our hospital. We enrolled patients receiving vedolizumab with or without previous anti-TNF-alpha agent exposure. The study results of continuous and categorical variables are presented as median (interquartile range [IQR]), with the IQR presented as 25th percentile to 75th percentile, and number (percentage), respectively. Categorical variables were compared with Fisher's exact test or Pearson's chi-square test, and continuous variables were compared with a Mann-WhitneyUtest. Twenty-four patients received vedolizumab from November 2017 to April 2019. Sixteen patients had finished the postinduction phase of the clinical evaluation. None of the patients discontinued vedolizumab due to an adverse drug reaction. The study group all fulfilled the criteria for clinical response and two of them achieved clinical remission. 50% of the patients could successfully discontinue systemic and topical steroid treatment. Three patients from CD group had endoscopic remission. Compare CD to UC patients, the efficacy of vedolizumab is comparable to both groups, but endoscopic response is slightly better in CD group. One patient developed systemic infection (urinary tract infection). None of tuberculosis complex infection or hepatitis B flare up observed during follow-up period. In this study, we offer our real-world experience of vedolizumab and suggest that the use of vedolizumanb is safe and effective. Moreover, 50% of steroid-dependent patients can discontinue steroid after vedolizumab induction. This can be addressed in the future study.

Automated summary

The study aimed to evaluate the efficacy and safety of vedolizumab in patients with IBD. Results showed that vedolizumab was effective in inducing clinical response and some patients were able to discontinue steroid treatment. Endoscopic remission was achieved in some patients as well.