Asthma is a common chronic respiratory disorder characterized by reversible airway obstruction, pulmonary inflammation, airway hyper-responsiveness, and airway remodelling.^1,2 Patients with asthma typically present with paroxysmal or persistent symptoms of wheezing, dyspnea, chest tightness, sputum production, and coughing that are associated with airflow limitation and airway hyper-responsiveness to endogenous and exogenous stimuli (e.g., exercise; viral respiratory infections; or exposure to certain allergens, irritants, or gases).² Severe eosinophilic asthma is an asthma phenotype characterized by the presence of eosinophils in the airways and sputum, despite compliance with conventional asthma therapy.³ Severe asthma can have a profound effect on patients’ day-to-day lives, such as limiting physical activity, reducing performance at work or school, restricting social interactions, and leading to stigma. It may also necessitate frequent physician and emergency room visits.

Reslizumab is a humanized immunoglobulin G (IgG)4 kappa monoclonal antibody that binds to human interleukin-5, thereby reducing the production and survival of eosinophils. Reslizumab was approved by Health Canada as add-on maintenance treatment for adult patients with severe eosinophilic asthma who are inadequately controlled with medium- to high-dose inhaled corticosteroids (ICSs) and an additional asthma controller(s) (e.g., long-acting beta-agonist [LABA]) and who have a blood eosinophil count of ≥ 400 cells/μL at initiation of the treatment. The recommended dose is 3 mg/kg administered by intravenous (IV) infusion every four weeks.⁴

The objective of this report was to perform a systematic review of the beneficial and harmful effects of reslizumab for the treatment of severe eosinophilic asthma in adults whose symptoms are inadequately controlled with medium- to high-dose ICS and an additional asthma controller(s) and who have a blood eosinophil count of ≥ 400 cells/μL.

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 Group(s) 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
  • APPENDIX 5. VALIDITY OF OUTCOME MEASURES
    • Aim
    • Findings
    • Asthma Quality of Life Questionnaire
    • Forced Expiratory Volume
    • Asthma Control Questionnaire 7
    • Asthma Symptom Utility Index
    • Conclusion
  • APPENDIX 6. SUMMARY OF THE EXTENSION STUDY (Study 3085)
    • Aim
    • Findings
    • Patient Disposition
    • Exposure
    • Safety
    • Efficacy
    • Conclusion
  • APPENDIX 7. SUMMARY OF INDIRECT COMPARISONS
    • Introduction
    • Review of Manufacturer’s Network Meta-Analysis
    • Conclusion
  • REFERENCES
• Clinical Pharmacoeconomic Report
  • ABBREVIATIONS
  • EXECUTIVE SUMMARY
    • Background
    • Summary of Key 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
    • 4. CADTH COMMON DRUG REVIEW REANALYSES
    • 5. ISSUES FOR CONSIDERATION
    • 6. PATIENT INPUT
    • 7. 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
    • Manufacturer’s Cost-Minimization Analysis
    • CADTH Common Drug Review Reanalyses
  • REFERENCES
• CDEC FINAL RECOMMENDATION
  • Recommendation
  • Reasons for the Recommendation
  • Of Note
  • Other Discussion Points
  • 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 allergy and clinical immunology 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.

CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.

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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.

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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.