GINA 2022 uptaded concept of asthma management

1. Treatment strategies for asthma
Reshaping the concept of asthma management
Dr. Mohammad Zannatul Rayhan
MD( Pulmonology)
Chest Disease Hospital, Rajshahi
Presented By

2. Asthma
 Asthma is a major noncommunicable disease (NCD)
 Heterogeneous disease, characterized by chronic airway inflammation
 Defined by history of respiratory symptoms, such as wheeze, shortness of
breath, chest tightness and cough, that vary over time and intensity, together
with variable expiratory airflow limitation

3. Asthma
 Airway limitation may later become persistent
 2019: 262 million cases and 4,55,000 deaths
 Most deaths occur in low- and lower-middle income countries
 Asthma cannot be cured, but good management can control the disease

4. Journal of Allergy and Clinical Immunology. 2007;120(5):S94-S138.
Pathophysiology

5. Journal of Allergy and Clinical Immunology. 2007;120(5):S94-S138.

6. Measures of asthma control
Severity
Level of treatment
required to control
symptoms
Control
Extent to which
asthma symptoms
can be reduced by
treatment
Responsiveness
The ease with which
control is achieved by
therapy
Journal of Allergy and Clinical Immunology. 2007;120(5):S94-S138.

7. Consequences of uncontrolled asthma
Airway remodeling
Scarring of the lungs
Permanent decline in respiratory function
Journal of Allergy and Clinical Immunology. 2007;120(5):S94-S138.

8. GINA 2022
Treatment of asthma in adults and adolescents
GINA: Global Initiative for Asthma
For detailed description of GINA methodology, see www.ginasthma.com/aboutus/methodology

9.  NOT just about medications, NOT one-size-fits-all
Diagnostic algorithm
GINA 2021 Box 3-2

10. Diagnosis at low and middle income
countries
 Clinical findings
 PEF >10% adult, >13% child
diurnal variation over 2 weeks
 PEF ≥20% improvement after 2
puffs BD
 Improvement of symptoms and
PEF >20% after 4 weeks of anti-
inflammatory treatment Peak flow meter

11.  NOT just about medications, NOT one-size-fits-all
Asthma management cycle
GINA 2021 Box 3-2

12. GINA 2022 treatment for
Adults & Adolescents
GINA recommended two ‘tracks’ of treatment, based on evidence -
 Track 1: low dose ICS-formoterol (as reliever), is the preferred approach
 Track 2 : SABA (as reliever), is an alternative approach
Stepped up or down within a track or switched between tracks, according to needs and preferences

13. GINA 2021, Box 3-4Bi
RELIEVER: As-needed short-acting β2-agonist
RELIEVER: As-needed low-dose ICS-formoterol
STEP 1
Take ICS whenever
SABA taken
STEP 2
Low dose
maintenance ICS
STEP 3
Low dose
maintenance
ICS-LABA
STEP 4
Medium/high
dose maintenance
ICS-LABA
STEP 5
Add-on LAMA
Refer for phenotypic
assessment ± anti-IgE,
anti-IL5/5R, anti-IL4R
Consider high dose
ICS-LABA
STEPS 1 – 2
As-needed low dose ICS-formoterol
STEP 3
Low dose
maintenance
ICS-formoterol
STEP 4
Medium dose
maintenance
ICS-formoterol
STEP 5
Add-on LAMA
Refer for phenotypic
assessment ± anti-IgE,
anti-IL5/5R, anti-IL4R
Consider high dose
ICS-formoterol
Symptoms most
days, or waking
with asthma once
a week or more
START
HERE IF:
Symptoms less
than 4–5 days
a week
Daily symptoms,
or waking with
asthma once a
week or more,
and low lung
function
Short course OCS may also be
needed for patients presenting
With severely uncontrolled
asthma
Symptoms most
days, or waking
with asthma once
a week or more
Symptoms less
than twice
a month
Daily symptoms,
or waking with
asthma once a
week or more,
and low lung
function
Short course OCS may also be
needed for patients presenting
with severely uncontrolled
asthma
Symptoms twice
a month or more,
but less than 4–5
days a week
• Confirm diagnosis
• Symptom control and
modifiable risk factors,
including lung function
• Comorbidities
• Inhaler technique and
adherence
• Patient preferences and
goals
FIRST
ASSESS:
CONTROLLER and
PREFERRED RELIEVER
(Track 1). Using ICS-formoterol as
reliever reduces the risk of
exacerbations compared with
using a SABA reliever
CONTROLLER and
ALTERNATIVE RELIEVER
(Track 2). Before considering a
regimen with SABA reliever,
check if the patient is likely to be
adherent with daily controller
START
HERE IF:
Stepwise Approach
Asthma Medications options: treatment up & down for individual patient needs
Other controller options for
either track
Low dose ICS
whenever SABA
taken, or daily LTRA,
or add HDM SLIT
Medium dose ICS, or
add LTRA, or add
HDM SLIT
Add LAMA or LTRA or
HDM SLIT, or switch to
high dose ICS
Add azithromycin (adults)
or LTRA; add low dose
OCS but consider side-
effects

14. Low dose ICS whenever
SABA taken, or daily LTRA,
or add HDM SLIT
Medium dose ICS, or
add LTRA, or add
HDM SLIT
Add LAMA or LTRA or
HDM SLIT, or switch to
high dose ICS
Add azithromycin (adults) or
LTRA. As last resort consider
adding low dose OCS but
consider side-effects
RELIEVER: As-needed short-acting beta2-agonist
STEP 1
Take ICS whenever
SABA taken
STEP 2
Low dose
maintenance ICS
STEP 3
Low dose
maintenance
ICS-LABA
STEP 4
Medium/high
dose maintenance
ICS-LABA
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-LABA, ± anti-IgE,
anti-IL5/5R, anti-IL4R,
anti-TSLP
RELIEVER: As-needed low-dose ICS-formoterol
STEPS 1 – 2
As-needed low dose ICS-formoterol
STEP 3
Low dose
maintenance
ICS-formoterol
STEP 4
Medium dose
maintenance
ICS-formoterol
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-formoterol,
± anti-IgE, anti-IL5/5R,
anti-IL4R, anti-TSLP
Treatment of modifiable risk factors
and comorbidities
Non-pharmacological strategies
Asthma medications (adjust down/up/between tracks)
Education & skills training
Adults & adolescents
12+ years
Personalized asthma management
Assess, Adjust, Review
for individual patient needs
Symptoms
Exacerbations
Side-effects
Lung function
Patient satisfaction
Confirmation of diagnosis if necessary
Symptom control & modifiable
risk factors (see Box 2-2B)
Comorbidities
Inhaler technique & adherence
Patient preferences and goals
CONTROLLER and
PREFERRED RELIEVER
(Track 1). Using ICS-formoterol
as reliever reduces the risk of
exacerbations compared with
using a SABA reliever
Other controller options for either
track (limited indications, or less
evidence for efficacy or safety)
CONTROLLER and
ALTERNATIVE RELIEVER
(Track 2). Before considering a
regimen with SABA reliever,
check if the patient is likely to be
adherent with daily controller
See GINA
severe
asthma guide
RELIEVER: As-needed low-dose ICS-formoterol
CONTROLLER and
PREFERRED RELIEVER
STEPS 1 – 2
As-needed low dose ICS-
formoterol
STEP 3
Low dose
maintenance
ICS-
formoterol
STEP 4
Medium
dose
maintenance
ICS-
formoterol
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-formoterol,
± anti-IgE, anti-IL5/5R,
anti-IL4R, anti-TSLP
© Global Initiative for Asthma, www.ginasthma.org
Adults & adolescents
12+ years
Personalized asthma management
GINA 2022, Box 3-5A, 2/4
Symptoms less
than 4–5 days a
week
Symptoms
most days, or
waking with
asthma once a
week or more
Daily symptoms, or
waking with asthma
once a week or
more, and low lung
function
Short course OCS may
also be needed for
patients presenting
With severely
uncontrolled asthma
Track 1
AIR MART

15. Low dose ICS whenever
SABA taken, or daily LTRA,
or add HDM SLIT
Medium dose ICS, or
add LTRA, or add
HDM SLIT
Add LAMA or LTRA or
HDM SLIT, or switch to
high dose ICS
Add azithromycin (adults) or
LTRA. As last resort consider
adding low dose OCS but
consider side-effects
RELIEVER: As-needed short-acting beta2-agonist
STEP 1
Take ICS whenever
SABA taken
STEP 2
Low dose
maintenance ICS
STEP 3
Low dose
maintenance
ICS-LABA
STEP 4
Medium/high
dose maintenance
ICS-LABA
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-LABA, ± anti-IgE,
anti-IL5/5R, anti-IL4R,
anti-TSLP
RELIEVER: As-needed low-dose ICS-formoterol
STEPS 1 – 2
As-needed low dose ICS-formoterol
STEP 3
Low dose
maintenance
ICS-formoterol
STEP 4
Medium dose
maintenance
ICS-formoterol
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-formoterol,
± anti-IgE, anti-IL5/5R,
anti-IL4R, anti-TSLP
Treatment of modifiable risk factors
and comorbidities
Non-pharmacological strategies
Asthma medications (adjust down/up/between tracks)
Education & skills training
Adults & adolescents
12+ years
Personalized asthma management
Assess, Adjust, Review
for individual patient needs
Symptoms
Exacerbations
Side-effects
Lung function
Patient satisfaction
Confirmation of diagnosis if necessary
Symptom control & modifiable
risk factors (see Box 2-2B)
Comorbidities
Inhaler technique & adherence
Patient preferences and goals
CONTROLLER and
PREFERRED RELIEVER
(Track 1). Using ICS-formoterol
as reliever reduces the risk of
exacerbations compared with
using a SABA reliever
Other controller options for either
track (limited indications, or less
evidence for efficacy or safety)
CONTROLLER and
ALTERNATIVE RELIEVER
(Track 2). Before considering a
regimen with SABA reliever,
check if the patient is likely to be
adherent with daily controller
See GINA
severe
asthma guide
RELIEVER: As-needed short-acting beta2-agonist
STEP 1
Take ICS whenever
SABA taken
STEP 2
Low dose
maintenance ICS
STEP 3
Low dose
maintenance
ICS-LABA
STEP 4
Medium/high
dose maintenance
ICS-LABA
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-LABA, ± anti-IgE,
anti-IL5/5R, anti-IL4R,
anti-TSLP
CONTROLLER and
ALTERNATIVE RELIEVER
© Global Initiative for Asthma, www.ginasthma.org
Adults & adolescents
12+ years
Personalized asthma management
GINA 2022, Box 3-5A, 3/4
Short course OCS
may also be needed
for patients
presenting With
severely
uncontrolled asthma
Daily symptoms, or
waking with asthma
once a week or more,
and low lung function
Symptoms most
days, or waking
with asthma once a
week or more
Symptoms less
than 4–5 days a
week
Symptoms less than
twice
a month
Track 2

16. Low dose ICS whenever
SABA taken, or daily LTRA,
or add HDM SLIT
Medium dose ICS, or
add LTRA, or add
HDM SLIT
Add LAMA or LTRA or
HDM SLIT, or switch to
high dose ICS
Add azithromycin (adults) or
LTRA. As last resort consider
adding low dose OCS but
consider side-effects
RELIEVER: As-needed short-acting beta2-agonist
STEP 1
Take ICS whenever
SABA taken
STEP 2
Low dose
maintenance ICS
STEP 3
Low dose
maintenance
ICS-LABA
STEP 4
Medium/high
dose maintenance
ICS-LABA
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-LABA, ± anti-IgE,
anti-IL5/5R, anti-IL4R,
anti-TSLP
RELIEVER: As-needed low-dose ICS-formoterol
STEPS 1 – 2
As-needed low dose ICS-formoterol
STEP 3
Low dose
maintenance
ICS-formoterol
STEP 4
Medium dose
maintenance
ICS-formoterol
STEP 5
Add-on LAMA
Refer for assessment
of phenotype. Consider
high dose maintenance
ICS-formoterol,
± anti-IgE, anti-IL5/5R,
anti-IL4R, anti-TSLP
Treatment of modifiable risk factors
and comorbidities
Non-pharmacological strategies
Asthma medications (adjust down/up/between tracks)
Education & skills training
Adults & adolescents
12+ years
Personalized asthma management
Assess, Adjust, Review
for individual patient needs
Symptoms
Exacerbations
Side-effects
Lung function
Patient satisfaction
Confirmation of diagnosis if necessary
Symptom control & modifiable
risk factors (see Box 2-2B)
Comorbidities
Inhaler technique & adherence
Patient preferences and goals
CONTROLLER and
PREFERRED RELIEVER
(Track 1). Using ICS-formoterol
as reliever reduces the risk of
exacerbations compared with
using a SABA reliever
Other controller options for either
track (limited indications, or less
evidence for efficacy or safety)
CONTROLLER and
ALTERNATIVE RELIEVER
(Track 2). Before considering a
regimen with SABA reliever,
check if the patient is likely to be
adherent with daily controller
See GINA
severe
asthma guide
Other controller options for
either track (limited indications,
or less evidence for efficacy or
safety)
Low dose ICS whenever
SABA taken, or daily
LTRA, or add HDM SLIT
Medium dose ICS, or
add LTRA, or add
HDM SLIT
Add LAMA or LTRA or
HDM SLIT, or switch to
high dose ICS
Add azithromycin (adults)
or LTRA. As last resort
consider adding low dose
OCS but consider side-
effects
© Global Initiative for Asthma, www.ginasthma.org
Adults & adolescents
12+ years
Personalized asthma management
GINA 2022, Box 3-5A, 4/4

17. Medium/high
dose ICS-LABA
+ as-needed SABA
Low dose
ICS-LABA
+ as-needed SABA
Low dose ICS
+ as-needed SABA
Take low dose
ICS whenever
SABA is taken
Low dose
ICS-formoterol
maintenance and
reliever (MART)
As-needed low dose
ICS-formoterol
As-needed low dose
ICS-formoterol
Daily symptoms, waking at
night once a week or more
and low lung function?
Symptoms most days,
or waking at night once
a week or more?
Symptoms twice a
month or more?
YES
NO
YES
IF:
STEP 1
STEP 2
STEP 4
Short course OCS may
also be needed for patients
presenting with severely
uncontrolled asthma
NO
STEP 3
START WITH:
NO
YES
FIRST ASSESS:
Confirmation
of diagnosis
Symptom control
& modifiable risk
factors (including
lung function)
Comorbidities
Inhaler technique
& adherence
Patient preferences
& goals
TRACK 2
OR
As-needed ICS-formoterol
is preferred if the patient is
likely to be poorly adherent
with daily ICS
ICS-containing therapy
is recommended even if
symptoms are infrequent,
as it reduces the risk of
severe exacerbations and
need for OCS.
TRACK 1
(preferred)
Medium dose
ICS-formoterol
maintenance and
reliever (MART)
Stepwise Approach

18. GINA Track 1 (preferred):
Reliever is low dose ICS-formoterol
 Why preferred ?
 Reduces the risk of severe exacerbations( Vs SABA)
 How used?
 At any step, low dose ICS-formoterol as needed
 Steps 3–5, ICS-formoterol daily controller treatment along with as needed. Together, this
is called ‘Maintenance and Reliever Therapy’ or ‘MART’
 When should it not be used?
 Should not be used in other ICS-LABA controller therapy

19. GINA Track 2 (alternative):
Reliever is SABA
 When should this be used?
 If Track 1 is not possible, or is not preferred by a patient
 How is it used?
 In Step 1, take ICS whenever SABA is taken
 In Steps 2–5, ICS-containing controller medication every day and SABA as needed
 When should it not be used?
 If poorly adherent to controller, will be at higher risk of exacerbations

20. Common problems
I have mild
symptoms.
Why not blue
Inhaler?

21. The risks of ‘mild’ asthma
 Risk
 30–37% of acute asthma
 16% of near-fatal asthma
 15–20% of dying of asthma
 Often triggers are unpredictable
 Inhaled SABA has been first-line treatment for mild asthma (50 years)
 Theory: bronchoconstriction
 rapid relief and low cost
 Starting treatment with SABA trains the patient
had symptoms less than weekly in previous
3 months (Dusser, Allergy 2007)

22. Kuprys-Lipinska et al. Clin Transl Allergy (2020) 10:19

23. Why did GINA extend as-needed
ICS-formoterol to Step 1?
 No evidence for safety or efficacy of SABA-only
 Patient with Infrequent symptoms: still have severe or fatal exacerbations
 Indirect evidence about safety and efficacy of as-needed ICS-formoterol
from four large RCTs
 The distinction between symptoms < and ≥ twice/month (or twice/week) is
arbitrary (not evidence-based)
 Starting with SABA alone habituated the patient with blue inhaler

24. Evidence for as-needed ICS-formoterol in Step 2
(n=9,565)
Vs SABA alone
 Severe exacerbations reduced by about two-thirds in a large double-blind study (O’Byrne,
NEJMed 2018) and in an open-label study in patients previously taking SABA alone (Beasley,
NEJMed 2019)
 Exercise-induced bronchoconstriction: greater reduction (Lazarinis, Thorax 2014)

25. Evidence for as-needed ICS-formoterol in Step 2
(n=9,565)
Vs daily low dose ICS with as-needed SABA
 Severe exacerbations: non-inferior in 2 large double-blind studies (O’Byrne NEJMed 2018;
Bateman NEJMed 2018) and superior in 2 open-label RCTs (Beasley NEJMed 2019; Hardy Lancet 2019)
 ICS dose: approx. 25–50% of dose
 Symptom control: very small difference in ACQ-5 (~0.1 vs MCID 0.5)
 Lung function: very small difference (~30–50 mL)
 FeNO: very small difference
 Exercise-induced bronchoconstriction: no significant difference (Lazarinis, Thorax 2014)
FeNO: fractional exhaled nitric oxide; ICS: inhaled corticosteroids; MCID: minimal clinically important difference; SABA: short-acting beta2-agonist

26. Other considerations
 Severe exacerbations can occur in mild asthma, often unpredictable
 ICS are highly effective in mild asthma, but patients are often poorly
adherent
 Short courses of OCS: risk of Osteoporosis, diabetes, cataract etc
 Differences in symptom control and lung function were not clinically
important

27. More

28. Mean use of SABA
Grouped according to maintenance therapy
Papi et al. Allergy Asthma Clin Immunol (2020) 16:75 https://doi.org/10.1186/s13223-020-00472-8

29. Steroid load
Papi et al. Allergy Asthma Clin Immunol (2020) 16:75 https://doi.org/10.1186/s13223-020-00472-8
Budesonide/formoterol MART Vs. ICS/LABA + SABA

30. Reduction of exacerbation
Bud/form reliever Vs SABA
Papi et al. Allergy Asthma Clin Immunol (2020) 16:75 https://doi.org/10.1186/s13223-020-00472-8

31. SABA Vs ICS- Formoterol reliever

32. Kuprys-Lipinska et al. Clin Transl Allergy (2020) 10:19

33. Blue inhaler

34. Soft reminder:
 ? Inhaler technique
 ? Adherence
 ? Environmental exposure
 ? Any D/D

35. SUMMARY
SABA is not preferred reliever
2022 GINA guidelines have been
updated to include using
budesonide-formoterol as-needed
first line for mild asthma
Budesonide-formoterol as-needed
lowers exacerbation rates