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Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Aug.

Cover of Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic)

Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet].

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Appendix 7Summary of Indirect Comparisons

Introduction and Background

Given the absence of head-to-head studies comparing abobotulinumtoxinA (AboBoNTA, Dysport Therapeutic) against other botulinum toxin type A (BoNTA) drugs in the study population relevant for this CADTH Common Drug Review (CDR), indirect treatment comparisons (ITCs) that include aboBoNTA can provide information on the effectiveness and safety of this drug compared with existing therapies. The objective of this appendix is to summarize and critically appraise the evidence available regarding the comparative efficacy and safety of any ITCs that compare aboBoNTA with onabotulinumtoxinA (onaBoNTA) in pediatric patients two years of age and older with lower-limb spasticity (LLS).

Methods

The manufacturer submitted one ITC64 that was reviewed, summarized, and critically appraised. CDR conducted an independent literature search for published ITCs that compared aboBoNTA with other relevant comparators for the treatment of LLS in pediatric patients two years of age and older; no published ITCs were identified.

Description of ITCs Identified

Table 52 presents the population, interventions, comparisons, outcomes, and study design (PICOS) criteria for the manufacturer-submitted ITC.

Table 52Inclusion and Exclusion Criteria for Selection of Studies

CriteriaInclusion CriteriaExclusion Criteria
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Comparator▬▬▬▬▬▬▬▬▬▬
Outcomes▬▬▬▬▬▬▬▬▬▬
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Source: Manufacturer-supplied indirect comparison.64

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Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK540252

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