Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that is localized to the colon, and symptoms include diarrhea, pain, bloody stools, fatigue, and weight loss. If left untreated, inflammation may progress, leading to mucosal damage and potentially fatal complications such as perforation and sepsis. According to the Crohn’s and Colitis Foundation of Canada in 2012, there are approximately 233,000 Canadians living with IBD, with 104,000 diagnosed with UC. More than 10,200 new cases of IBD are diagnosed every year (5,700 with Crohn’s disease [CD] and 4,500 with UC), an incidence of 0.7%; 20% to 30% of people with IBD are diagnosed before the age of 20 years. Budesonide is a corticosteroid with anti-inflammatory properties, although the precise mechanism of action is not known. The oral and rectal formulations of budesonide have existing indications for the management of UC and CD. Budesonide MMX (Multi Matrix System) is a new formulation of budesonide that is available as 9 mg delayed- and extended-release tablets for oral administration. The Health Canada indication is for the induction of remission in patients with active, mild to moderate UC. The recommended dose is one tablet per day in the morning for up to 8 weeks.

The objective of this review is to perform a systematic review of the beneficial and harmful effects of budesonide MMX for the induction of remission in patients with active, mild to moderate UC.

Contents

• Clinical Review Report
  • ABBREVIATIONS
  • EXECUTIVE SUMMARY
    • Introduction
    • Results and interpretation
    • Conclusions
  • 1. INTRODUCTION
    • 1.1. Disease prevalence and incidence
    • 1.2. Standards of therapy
    • 1.3. Drug
  • 2. OBJECTIVES AND METHODS
    • 2.1. Objectives
    • 2.2. Methods
  • 3. RESULTS
    • 3.1. Findings from the literature
    • 3.2. Included studies
    • 3.3. Patient disposition
    • 3.4. Exposure to study treatments
    • 3.5. Critical appraisal
    • 3.6. Efficacy
    • 3.7. Harms
  • 4. DISCUSSION
    • 4.1. Summary of available evidence
    • 4.2. Interpretation of results
    • 4.3. Potential place in therapy
  • 5. CONCLUSIONS
  • APPENDIX 1. PATIENT INPUT SUMMARY
    • 1. Brief description of patient groups supplying input
    • 2. Condition-related information
    • 3. Current therapy–related information
    • 4. Expectations about the drug being reviewed
  • APPENDIX 2. LITERATURE SEARCH STRATEGY
  • APPENDIX 3. EXCLUDED STUDIES
  • APPENDIX 4. DETAILED OUTCOME DATA
    • Subgroup analyses
    • Histological healing
  • APPENDIX 5. VALIDITY OF OUTCOME MEASURES
    • Aim
    • Findings
    • Summary
  • APPENDIX 6. SUMMARY OF COCHRANE SYSTEMATIC REVIEW OF ORAL BUDESONIDE
    • 1. Objective
    • 2. Findings
  • APPENDIX 7. SUMMARY OF INDIRECT COMPARISONS
    • Introduction
    • Methods
    • Review and Appraisal of Indirect Comparisons
    • Discussion
    • Conclusion
  • REFERENCES
• Pharmacoeconomic Review Report
  • ABBREVIATIONS
  • EXECUTIVE SUMMARY
    • Background
    • Summary of identified limitations
    • Key results and conclusions
  • INFORMATION ON THE PHARMACOECONOMIC SUBMISSION
    • 1. SUMMARY OF THE MANUFACTURER’S PHARMACOECONOMIC SUBMISSION
    • 2. MANUFACTURER’S BASE CASE
      • Summary of manufacturer’s sensitivity analyses
    • 3. LIMITATIONS OF MANUFACTURER’S SUBMISSION
      • Uncertainty regarding clinical effectiveness data comparing budesonide MMX to 5-ASA based on manufacturer’s network meta-analysis
      • Omission of relevant comparators
      • CADTH Common Drug Review reanalyses
    • 4. ISSUES FOR CONSIDERATION
      • Patient input
    • 5. CONCLUSIONS
  • APPENDIX 1. COST COMPARISON
  • APPENDIX 2. SUMMARY OF KEY OUTCOMES
  • APPENDIX 3. ADDITIONAL INFORMATION
  • APPENDIX 4. SUMMARY OF OTHER HEALTH TECHNOLOGY ASSESSMENT REVIEWS OF DRUG
  • APPENDIX 5. REVIEWER WORKSHEETS
    • Manufacturer’s model structure
    • Manufacturer’s Results and CADTH Common Drug Review Reanalysis
    • Sensitivity analyses
  • REFERENCES
• CDEC FINAL RECOMMENDATION
  • Recommendation
  • Reasons for the Recommendation
  • Of Note
  • Discussion Points
  • Research Gaps
  • Background
  • Summary of CDEC Considerations

This review report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition to CADTH staff, the review team included a clinical expert in gastroenterology who provided input on the conduct of the review and the interpretation of findings.

The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.

While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.

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The statements, findings, conclusions, views, and opinions contained and expressed in this publication are based in part on data obtained under license from IMS Health Canada Inc. concerning the following information service: DeltaPA. All Rights Reserved. Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third-party data supplier.