GINA Pocket Guide Difficult to treat and severe asthma in adults and adolescents

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GINA Pocket Guide Difficult to treat and severe asthma in adults and adolescents

V2.0 April 2019

is supported only by the sale and licensing of GINA

resources

Declaration of interest

guidelines undergo a thorough initial development, with infrequent updates
Conventional

evaluation of evidence places a high importance on internal validity
Low importance is given to external validity, despite study populations being highly selected
Recommendations may not be generalizable to patients seen in normal clinical practice
Guidelines are often written in academic language
Evidence is typically compiled as answers to individual PICOT* questions
May have limited relevance to day-to-day clinical practice
Much of current literature on severe asthma focuses on biologic therapies
There are many more patients with difficult-to-treat asthma than with severe asthma, and clinicians need practical advice about how to distinguish these patients, including in primary care
Advice is also needed by clinicians in areas where biologics are not available or affordable

Limitations of current resources about severe asthma

*PICOT: a framework for constructing research questions – what is the Population, Intervention, Control, Outcome, Time period?

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evidence-based strategy focusing on translation into clinical practice
Recommendations are framed,

not as answers to isolated PICOT questions, but as part of an integrated strategy, in relation to:
The GINA goals of preventing asthma deaths and exacerbations, as well as improving symptom control
Current understanding of underlying disease processes
Human behavior (of health professionals and patients/carers)
Implementation in clinical practice
Global variation in populations, health systems and medication access
GINA provides practical resources for clinicians
Figures and tables about implementation in clinical practice: not just ‘what’, but ‘how to’
A survey of GINA Assembly members in 2017 strongly encouraged development of a practical resource about severe asthma

About the GINA strategy

© Global Initiative for Asthma, www.ginasthma.org

normal lung function
Prevent flare-ups (exacerbations)
Prevent asthma deaths
Avoid medication side-effects

The

patient’s goals may be different from these
Symptoms and risk may be discordant – need to assess both

Symptom control

Risk reduction

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may potentially have mild asthma, i.e. their asthma could be

well-controlled with low dose ICS, if taken regularly
Difficult-to-treat asthma
(not difficult patients!)
Asthma uncontrolled despite prescribing high dose preventer treatment
Contributory factors may include incorrect diagnosis, incorrect inhaler technique, poor adherence, comorbidities
Severe asthma
“Severe asthma” has had many different meanings (Taylor, ERJ 2008; Reddel AJRCCM 2009)
Now defined as asthma that is uncontrolled despite maximal optimised therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased (Chung, ERJ 2014)
i.e. relatively refractory to corticosteroids (rarely completely refractory)
A retrospective definition, dependent on how thoroughly contributory factors are excluded

© Global Initiative for Asthma, www.ginasthma.org

development, biochemical or physiological properties, or behaviour.
Patients with an

identified phenotype of obstructive lung disease may share a cluster of clinical, functional and/or inflammatory features, without any implication of a common underlying mechanism
Examples: allergic asthma, aspirin-exacerbated respiratory disease, severe eosinophilic asthma
Endotype: A subtype of disease, defined functionally and pathologically by a distinct molecular mechanism or by distinct treatment responses (Anderson, Lancet 2008)
Among patients with obstructive lung disease, there are likely to be several specific endotypes associated with divergent underlying molecular causes, and with distinct treatment responses. These endotypes may or may not align with clinical or inflammatory phenotypes identified from studies limited to asthma or to COPD
Examples: emphysema due to alpha1-antitrypsin deficiency
Biomarker: A defined characteristic measured as an indicator of normal biologic processes, pathogenic processes or response to an intervention
Potential examples: FeNO, blood eosinophils – but these may not meet quality criteria for biomarkers

Terminology

Anderson, Lancet 2008; Reddel, ERJ Open Res 2019

© Global Initiative for Asthma, www.ginasthma.org

Illinois
Hugh Musick, Associate Director, Program for Healthcare Delivery Design, University

of Illinois
Helen Reddel, Chair of GINA Science committee
Members of the GINA Science Committee

Team who developed pocket guide

© Global Initiative for Asthma, www.ginasthma.org

prominent authors in the field)
Developed interview protocols
Interviewed key GINA

members and external experts/GPs previously identified as advisors for input
Transcribed interviews
Aligned content with GINA’s existing key messages
Collected existing published guidelines for reference
Researched printing possibilities and limitations

Methods used to develop v1.0 of pocket guide

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into pocket guide outline provided by content expert
Parsed textual outline

into diagrammatic decision tree structures
Integrated additional inputs from experts and literature
Incorporated feedback from experts, iterated
Incorporated color
Booklet design overall: (20 hrs, 5 versions)
Integrated decision tree to fit booklet format
Formatted detailed text pages to complete the pocket guide
Designed Table of Contents to represent at-a-glance algorithm
Increased total length of pocket guide to 36 pages
V2.0 published in April 2019

Methods used to develop V1.0 of pocket guide

© Global Initiative for Asthma, www.ginasthma.org

blood/sputum eosinophils and FeNO listed here are the lowest levels

associated with good response to any of the included biologics
These are not the criteria for individual biologic therapies, which come later in the decision tree, and for which local regulator/payer criteria need to be checked
Addition of need for maintenance OCS, as this may have suppressed evidence of T2 inflammation
Section 6b: Additional class of T2-targeted treatment: anti-IL4 receptor alpha (dupilumab)
For patients with severe eosinophilic asthma or need for maintenance OCS
Section 6b: review response to initial trial of biologic
Consider increasing trial of biologic to 6-12 months if initial response is unclear
Section 7: review response
Process of reviewing need for add-on therapy in patients with good and poor response to biologic therapy has been clarified

Severe Asthma Pocket Guide v2.0: key changes