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Whats-new-in-GINA-2019 - V2-Power Point
Whats-new-in-GINA-2019 - V2-Power Point
■ Patients with apparently mild asthma are at risk of serious adverse events
▪ 30–37% of adults with acute asthma
▪ 16% of patients with near-fatal asthma had symptoms less than weekly in previous
3 months (Dusser, Allergy 2007)
▪ 15–20% of adults dying of asthma
■ Exacerbation triggers are variable (viruses, pollens, pollution, poor adherence)
■ Inhaled SABA has been first-line treatment for asthma for 50 years
▪ This dates from an era when asthma was thought to be a disease of
bronchoconstriction
▪ Patient satisfaction with, and reliance on, SABA treatment is reinforced by its rapid
relief of symptoms, its prominence in ED and hospital management of exacerbations,
and low cost
▪ Patients commonly believe that “My reliever gives me control over my asthma”, so
they often don’t see the need for additional treatment
Previously, no controller
was recommended for
Step 1, i.e. SABA-only
treatment was ‘preferred’
GINA 2018, Box 3-5 (2/8) (upper part) © Global Initiative for Asthma, www.ginasthma.org
GINA 2019 – landmark changes in asthma management
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Box 3-5A Confirmation of diagnosis if necessary
Adults & adolescents 12+ years Symptom control & modifiable
risk factors (including lung function)
Comorbidities
Inhaler technique & adherence
Personalized asthma management: Patient goals
Assess, Adjust, Review response
Symptoms
Exacerbations
Side-effects
Lung function
Patient satisfaction Treatment of modifiable risk
factors & comorbidities STEP 5
Non-pharmacological strategies
Education & skills training High dose
Asthma medication options: Asthma medications ICS-LABA
Adjust treatment up and down for STEP 4 Refer for
individual patient needs phenotypic
STEP 3 Medium dose assessment
STEP 2 ICS-LABA ± add-on
PREFERRED STEP 1
Low dose therapy,
CONTROLLER Daily low dose inhaled corticosteroid (ICS), ICS-LABA e.g.tiotropium,
to prevent exacerbations As-needed or as-needed low dose ICS-formoterol * anti-IgE,
and control symptoms low dose anti-IL5/5R,
ICS-formoterol * anti-IL4R
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Box 3-5A Confirmation of diagnosis if necessary
Adults & adolescents 12+ years Symptom control & modifiable
risk factors (including lung function)
Comorbidities
Inhaler technique & adherence
Personalized asthma management: Patient goals
Assess, Adjust, Review response
Symptoms
‘Controller’ treatment Exacerbations
Side-effects
means the treatment Lung function
taken to prevent Patient satisfaction Treatment of modifiable risk
factors & comorbidities STEP 5
exacerbations Non-pharmacological strategies
Education & skills training High dose
Asthma medication options: Asthma medications ICS-LABA
Adjust treatment up and down for STEP 4 Refer for
individual patient needs phenotypic
STEP 3 Medium dose assessment
STEP 2 ICS-LABA ± add-on
PREFERRED STEP 1
Low dose therapy,
CONTROLLER Daily low dose inhaled corticosteroid (ICS), ICS-LABA e.g.tiotropium,
to prevent exacerbations As-needed or as-needed low dose ICS-formoterol * anti-IgE,
and control symptoms low dose anti-IL5/5R,
ICS-formoterol * anti-IL4R
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options
taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Step 2 – rationale for changes
in GINA 2019
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Step 2 – there are two ‘preferred’ controller options
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Step 2 - other controller options
Low dose ICS taken whenever SABA taken (off-label, separate or combination inhalers)
■ Evidence
▪ Two RCTs showed reduced exacerbations compared with SABA-only treatment
• BEST, in adults, with combination ICS-SABA (Papi, NEJMed 2007)
• TREXA, in children/adolescents, with separate inhalers (Martinez, Lancet 2011)
▪ Three RCTs showed similar or fewer exacerbations compared with maintenance ICS
• TREXA, BEST
• BASALT in adults, separate inhalers, vs physician-adjusted treatment (Calhoun, JAMA 2012)
■ Values and preferences
▪ High importance given to preventing severe exacerbations
▪ Lower importance given to small differences in symptom control and the inconvenience
of needing to carry two inhalers
▪ Combination ICS-SABA inhalers are available in some countries, but approved only for
maintenance use
■ Another option: leukotriene receptor antagonist (less effective for exacerbations)
© Global Initiative for Asthma, www.ginasthma.org
Step 1 – rationale for changes
in GINA 2019
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Step 1 – ‘preferred’ controller option
■ Step 1 is for patients with symptoms less than twice a month, and with
no exacerbation risk factors
As-needed low dose ICS-formoterol (off-label)
■ Evidence
▪ Indirect evidence from SYGMA 1 of large reduction in severe exacerbations vs
SABA-only treatment in patients eligible for Step 2 therapy (O’Byrne, NEJMed 2018)
■ Values and preferences
▪ High importance given to reducing exacerbations
▪ High importance given to avoiding conflicting messages about goals of asthma
treatment between Step 1 and Step 2
▪ High importance given to poor adherence with regular ICS in patients with infrequent
symptoms, which would expose them to risks of SABA-only treatment
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Box 3-5A Confirmation of diagnosis if necessary
Adults & adolescents 12+ years Symptom control & modifiable
risk factors (including lung function)
Comorbidities
Inhaler technique & adherence
Personalized asthma management: Patient goals
Assess, Adjust, Review response
See severe asthma
Symptoms Pocket Guide for
Exacerbations
Side-effects
details about Step 5
Lung function
Patient satisfaction Treatment of modifiable risk
factors & comorbidities STEP 5
Non-pharmacological strategies
Education & skills training High dose
Asthma medication options: Asthma medications ICS-LABA
Adjust treatment up and down for STEP 4 Refer for
individual patient needs phenotypic
STEP 3 Medium dose assessment
STEP 2 ICS-LABA ± add-on
PREFERRED STEP 1
Low dose therapy,
CONTROLLER Daily low dose inhaled corticosteroid (ICS), ICS-LABA e.g.tiotropium,
to prevent exacerbations As-needed or as-needed low dose ICS-formoterol * anti-IgE,
and control symptoms low dose anti-IL5/5R,
ICS-formoterol * anti-IL4R
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Medium dose High dose ICS, Add low dose
controller options taken whenever low dose ICS taken whenever SABA taken † ICS, or low dose add-on OCS, but
SABA is taken † ICS+LTRA # tiotropium, or consider
add-on LTRA # side-effects
PREFERRED As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
RELIEVER
Other
reliever option As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form) ‡ Low-dose ICS-form is the reliever for patients prescribed bud-
† Off-label; separate or combination ICS and SABA inhalers form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with allergic
© Global Initiative for Asthma, www.ginasthma.org rhinitis and FEV >70%
1 predicted
Changes in GINA 2019 –
children 6-11 years
Other Low dose ICS Leukotriene receptor antagonist (LTRA), or Low dose High dose ICS- Add-on anti-IL5,
controller options taken whenever low dose ICS taken whenever SABA taken* ICS+LTRA LABA, or add- or add-on low
SABA taken*; or on tiotropium, or dose OCS,
daily low dose ICS add-on LTRA but consider
side-effects
* Off-label; separate ICS and SABA inhalers; only one study in children
Children 6-11 years
■ Step 4
▪ Medium dose ICS-LABA, but refer for expert advice
■ Step 3
▪ Low dose ICS-LABA and medium dose ICS are ‘preferred’ controller treatments
▪ No safety signal with ICS-LABA in children 4-11 years (Stempel, NEJMed 2017)
■ Step 2
▪ Preferred controller is daily low dose ICS
▪ Other controller options include as-needed low dose ICS taken whenever SABA is
taken, but only one study in children (Martinez, Lancet 2011)
▪ Studies of as-needed ICS-formoterol are needed; maintenance and reliever therapy
with low dose budesonide-formoterol in children 4-11 years reduced exacerbations by
70-79% compared with ICS and ICS-LABA (Bisgaard, Chest 2006)
■ Step 1
▪ Low dose ICS whenever SABA taken (indirect evidence), or daily low dose ICS
© Global Initiative for Asthma, www.ginasthma.org
Other changes in GINA 2019
■ Updated strategies for ‘yellow zone’ of action plans, with new evidence
▪ 4x increase in ICS dose decreased severe exacerbations in pragmatic study in adults
(McKeever, NEJMed 2018)
▪ 5x increase in ICS dose did not decrease severe exacerbations in children with good
symptom control and high adherence (Jackson, NEJMed 2018)
■ Pre-school asthma
▪ Additional suggestions for investigating history of wheezing episodes
▪ Early referral recommended if child fails to respond to controller treatment
▪ For exacerbations, OCS not generally recommended except in ED setting
▪ Follow-up after ED or hospital: within 1-2 working days and 3-4 weeks later
▪ Pocket guide on management of asthma in children 5 years and younger will be
updated in 2019