The objective of this review is to perform a systematic review of the beneficial and harmful effects of vedolizumab subcutaneous injection for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, loss of response to, or were intolerant to either conventional therapy or infliximab, a tumour necrosis factor alpha antagonist.

Contents

• Abbreviations
• Executive Summary
  • Introduction
  • Stakeholder Engagement
  • Clinical Evidence
  • Conclusions
• Introduction
  • Disease Background
  • Standards of Therapy
  • Drug
• Stakeholder Engagement
  • Patient Group Input
  • Clinician Input
• Clinical Evidence
  • Systematic Review (Pivotal and Protocol Selected Studies)
  • Findings From the Literature
  • Results
  • Indirect Evidence
  • Other Relevant Evidence
  • Conclusion
• Discussion
  • Summary of Available Evidence
  • Interpretation of Results
• Conclusions
• Appendix 1. Literature Search Strategy
• Appendix 2. Excluded Studies
• Appendix 3. Detailed Outcome Data
• Appendix 4. Description and Appraisal of Outcome Measures
• References

Version: Final (with redactions)

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