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Asthma Mangement: Time for a New Approach

1. The document outlines the GINA treatment steps for asthma management, which involve a stepwise approach to treatment based on asthma severity and control. 2. It begins with Step 1 involving use of a short-acting beta 2 agonist as needed and considers adding regular low-dose inhaled corticosteroids. 3. Steps then involve adding controllers as symptoms are not well controlled, such as low-dose inhaled corticosteroids and long-acting beta 2 agonists in Step 2, and medium-dose controllers in Steps 3 and 4. Step 5 involves referral to specialist care for add-on treatments.

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Introduction to GINA and timeline from 1995 to 2018, highlighting the importance of asthma management.

Introduction to GINA and timeline from 1995 to 2018, highlighting the importance of asthma management.

Introduction to GINA and timeline from 1995 to 2018, highlighting the importance of asthma management.

Stepwise asthma management outlined, emphasizing education, control options, and treatment escalation.

Introduction to GINA and timeline from 1995 to 2018, highlighting the importance of asthma management.

Stepwise asthma management outlined, emphasizing education, control options, and treatment escalation.

Stepwise asthma management outlined, emphasizing education, control options, and treatment escalation.

Stepwise asthma management outlined, emphasizing education, control options, and treatment escalation.

Stepwise asthma management outlined, emphasizing education, control options, and treatment escalation.

Step 1 recommendation revisions for asthma management focusing on as-needed SABA and low-dose ICS.

Step 1 recommendation revisions for asthma management focusing on as-needed SABA and low-dose ICS.

Step 1 recommendation revisions for asthma management focusing on as-needed SABA and low-dose ICS.

Overview of Step 2 treatments including low-dose ICS and other controller medication options.

Overview of Step 2 treatments including low-dose ICS and other controller medication options.

Overview of Step 2 treatments including low-dose ICS and other controller medication options.

Overview of Step 2 treatments including low-dose ICS and other controller medication options.

Overview of Step 2 treatments including low-dose ICS and other controller medication options.

Changes in controller strategies for asthma treatment discussed for steps 3 and 4 including add-ons.

Changes in controller strategies for asthma treatment discussed for steps 3 and 4 including add-ons.

Changes in controller strategies for asthma treatment discussed for steps 3 and 4 including add-ons.

Step 5 management emphasizing specialized treatment, reviewing options like anti-IgE and anti-IL5 therapies.

Step 5 management emphasizing specialized treatment, reviewing options like anti-IgE and anti-IL5 therapies.

Guidelines for initiating asthma treatment and monitoring adjustments based on patient response.

Guidelines for initiating asthma treatment and monitoring adjustments based on patient response.

Significant updates in treatment guidelines from GINA regarding risks of SABA-only management and strategies for mild asthma.

Significant updates in treatment guidelines from GINA regarding risks of SABA-only management and strategies for mild asthma.

Significant updates in treatment guidelines from GINA regarding risks of SABA-only management and strategies for mild asthma.

Significant updates in treatment guidelines from GINA regarding risks of SABA-only management and strategies for mild asthma.

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1
By
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Global INitiative for Asthma www.ginasthma.com
1995 2002 2006 2014
Step 2 Step 3 Step 4 Step 5Step 1 Asthma Education Enviromental Control As needed rapid acting 2 agonists As needed rapid acting 2 agonists Controller options Select one Select one Add one or more Add one or both Low-dose ICS Low-dose ICS + LABA Medium or high dose ICS+ LABA Oral steroid LTRA Medium or high dose ICS LTRA Anti-IgE Low-dose ICS + LTRA Theophylline Low-dose ICS + Theophylline INCREASEREDUCE TREATMENT STEPS GINA 2013 As needed rapid acting B2-agonist
GINA 2014
10 GINA 2014
GINA 2018
GINA 2017, Box 3-2 Diagnosis Symptom control & risk factors (including lung function) Inhaler technique & adherence Patient preference Asthma medications Non-pharmacological strategies Treat modifiable risk factors Symptoms Exacerbations Side-effects Patient satisfaction Lung function The control-based asthma management cycle
14 • How? – Asthma severity is assessed retrospectively from the level of treatment required to control symptoms and exacerbations • When? – Assess asthma severity after patient has been on controller treatment for several months – Severity is not static – it may change over months or years, or as different treatments become available Assessment of Asthma Severity
15 Categories of asthma severity – Mild asthma: Well-controlled with Steps 1 or 2 (as-needed SABA or low dose ICS) – Moderate asthma: Well-controlled with Step 3 (low-dose ICS/LABA) – Severe asthma: Requires Step 4/5 (moderate or high dose ICS/LABA ± add-on), or remains uncontrolled despite this treatment
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Stepwise management
 Maintain control by stepping up treatment as necessary. How do we apply the stepwise approach?
Stepping down Ensure regular review of patients as treatment is stepped down Decide which drug to step down first and at what rate When control is good, step down.
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Step 1 treatment is for patients with symptoms <twice/month Previously, no controller was recommended for Step 1, i.e. SABA-only treatment was ‘preferred’ GINA 2018 – main treatment figure
 Preferred option: as-needed inhaled short-acting beta2-agonist (SABA)  SABAs are highly effective for relief of asthma symptoms  However …. there is insufficient evidence about the safety of treating asthma SABA alone  This option should be reserved for patients with infrequent symptoms (less than twice a month) of short duration, and with no risk factors for exacerbations  Other options  Consider adding regular low dose inhaled corticosteroid (ICS) for patients at risk of exacerbations Step 1 – as-needed reliever inhaler 2018 GINA 2017
 Daily Low dose ICS has been suggested by GINA since 2014 in step1 to reduce the risk of severe exacerbations .  However, patients with symptoms less than twice a month are unlikely to take ICS regularly, leaving them exposed to the risks of SABA-only treatment.
 Preferred option: regular low dose ICS with as-needed inhaled SABA  Low dose ICS reduces symptoms and reduces risk of exacerbations and asthma- related hospitalization and death  Other options  Leukotriene receptor antagonists (LTRA) with as-needed SABA  Less effective than low dose ICS  May be used for some patients with both asthma and allergic rhinitis, or if patient will not use ICS  Combination low dose ICS/long-acting beta2-agonist (LABA) with as-needed SABA  Reduces symptoms and increases lung function compared with ICS  More expensive, and does not further reduce exacerbations  Intermittent ICS with as-needed SABA for purely seasonal allergic asthma with no interval symptoms  Start ICS immediately symptoms commence, and continue for 4 weeks after pollen season ends Step 2 – Low dose controller + as-needed SABA 2018 GINA 2017
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GINA 2017, Box 3-5, Step 1 (4/8) Start controller treatment early – For best outcomes, initiate controller treatment as early as possible after making the diagnosis of asthma Indications for regular low-dose ICS - any of : – Asthma symptoms more than twice a month – Waking due to asthma more than once a month – Any asthma symptoms plus any risk factors for exacerbations Recommended Initial Treatment Step
Treatment Options for adult Patients Not Controlled on low dose Inhaled Steroids Patients not controlled on Low dose ICS Increase the dose of inhaled steroid Add leukotriene receptor antagonists Add long-acting beta2-agonists Add theophylline
35 Step 3 – one or two controllers + as-needed inhaled reliever
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Symbicort SMART Symbicort Maintenance And Reliever Therapy Formoterol Budesonide SABA
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43 Symbicort + Symbicort
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 Combination inhalers of salmeterol with an ICS, such as Seretide, are not suitable for single inhaler maintenance and reliever therapy.  Salmeterol should not be used for the relief of acute asthma symptoms because it has a significantly slower onset of action than either formoterol, salbutamol or terbutaline. 49
GINA 2015 – changes to Steps 4 and 5 © Global Initiative for AsthmaGINA 2015, Box 3-5, Steps 4 and 5 *For children 6-11 years, theophylline is not recommended, and preferred Step 3 is medium dose ICS **For patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy # Tiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years. Other controller options RELIEVER STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 Low dose ICS Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* Med/high dose ICS Low dose ICS+LTRA (or + theoph*) As-needed short-acting beta2-agonist (SABA) Low dose ICS/LABA* Med/high ICS/LABA Refer for add-on treatment e.g. anti-IgE PREFERRED CONTROLLER CHOICE Add tiotropium# High dose ICS + LTRA (or + theoph*) Add tiotropium# Add low dose OCS As-needed SABA or low dose ICS/formoterol**
55 • Add-on tiotropium by soft-mist inhaler is a new ‘other controller option’ for Steps 4 and 5, in patients ≥ 18 years with history of exacerbations What’s new in GINA 2015
© Global Initiative for Asthma© Global Initiative for Asthma Step 4 – two or more controllers + as-needed inhaled reliever GINA 2016, Box 3-5, Step 4 (7/8) Other controller options RELIEVER STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 Low dose ICS Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* Med/high dose ICS Low dose ICS+LTRA (or + theoph*) As-needed short-acting beta2-agonist (SABA) Low dose ICS/LABA** Med/high ICS/LABA PREFERRED CONTROLLER CHOICE *Not for children <12 years **For children 6-11 years, the preferred Step 3 treatment is medium dose ICS #For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy  Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations Refer for add-on treatment e.g. tiotropium,* omalizumab, mepolizumab* As-needed SABA or low dose ICS/formoterol# Add tiotropium* High dose ICS + LTRA (or + theoph*) Add low dose OCS
57 Consider adding sublingual immunotherapy (SLIT) in adult HDM-sensitive patients with allergic rhinitis and asthma who have exacerbations despite ICS treatment, provided FEV1 is 70% predicted In such patients with exacerbations despite taking step 3 or step 4 therapy (according to GINA), SLIT can now be considered as add on therapy UPDATED 2017
GINA 2018 – main treatment figure
© Global Initiative for Asthma Step 5 – higher level care and/or add-on treatment GINA 2016, Box 3-5, Step 5 (8/8) Other controller options RELIEVER STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 Low dose ICS Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* Med/high dose ICS Low dose ICS+LTRA (or + theoph*) As-needed short-acting beta2-agonist (SABA) Low dose ICS/LABA** Med/high ICS/LABA PREFERRED CONTROLLER CHOICE *Not for children <12 years **For children 6-11 years, the preferred Step 3 treatment is medium dose ICS #For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy  Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations Refer for add-on treatment e.g. tiotropium,* omalizumab, mepolizumab* As-needed SABA or low dose ICS/formoterol# Add tiotropium* High dose ICS + LTRA (or + theoph*) Add low dose OCS
© Global Initiative for Asthma Preferred option is referral for specialist investigation and consideration of add-on treatment  If symptoms uncontrolled or exacerbations persist despite Step 4 check inhaler technique and adherence before referring  Add-on tiotropium for patients ≥12 years with history of exacerbations  Add-on anti-IgE (omalizumab) for patients with severe allergic asthma  Add-on anti-IL5 (mepolizumab (SC) or reslizumab (IV)) for severe eosinophilic asthma (≥12 yrs) Other add-on treatment options at Step 5 include:  Sputum-guided treatment: this is available in specialized centers; reduces exacerbations and/or corticosteroid dose  Add-on low dose oral corticosteroids (≤7.5mg/day prednisone equivalent): this may benefit some patients, but has significant systemic side-effects. Assess and monitor for osteoporosis Step 5 – higher level care and/or add-on treatment GINA 2017 UPDATED 2017
ClAdd-on Controller Medication  Long-acting anticholinergic (At Step 4 or 5 with a history of exacerbations despite ICS ± LABA) : Tiotropium  Anti-IgE (with severe allergic asthma uncontrolled on high dose ICS- LABA): Omalizumab
ClAdd-on Controller Medication  Anti-IL5 & Anti-IL5R (Severe eosinophilic asthma uncontrolled on high dose ICS-LABA)  Mepolizumab & Reslizumab  Benralizumab  Anti-IL4R (Severe eosinophilic asthma uncontrolled on high dose ICS-LABA, or requiring maintenance OCS)  Dupilumab
Children’s Healthcare of Atlanta 66
ClStarting Asthma Treatment  ICS-containing treatment should be initiated as soon as possible after the diagnosis of asthma is made.  Consider starting at a higher step (e.g. medium/high dose ICS, or low-dose ICS-LABA) if on most days the patient has troublesome asthma symptoms; or is waking from asthma once or more a week.
ClStarting Asthma Treatment  If the initial asthma presentation is with severely uncontrolled asthma, or with an acute exacerbation, give a short course of OCS and start regular controller treatment (e.g. medium dose ICS-LABA).  Consider stepping down after asthma has been well controlled for 3 months. However, in adults and adolescents, ICS should not be completely stopped.
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CAfter Starting Initial Controller Treatment  Review response after 2–3 months, or according to clinical urgency.  Review for ongoing treatment and other key management issues.  Consider step down when asthma has been well controlled for 3 months.
C Reviewing response and adjusting treatment  Patients should preferably be seen 1–3 months after starting treatment  Every 3–12 months after that, but in pregnancy, asthma should be reviewed every 4–6 weeks.  After an exacerbation, a review visit within 1 week should be scheduled.
C Stepping up treatment  Sustained step-up (for at least 2–3 months): if symptoms and/or exacerbations persist despite 2–3 months of controller treatment, assess the following common issues before considering a step-up • Incorrect inhaler technique • Poor adherence • Modifiable risk factors • Comorbid conditions
C Stepping up treatment  Short-term step-up (for 1–2 weeks) by clinician or by patient with written asthma action plan, e.g. during viral infection or allergen exposure.  Day-to-day adjustment by patient for those who prescribed as-needed low dose ICS formoterol for mild asthma, or low dose ICS-formoterol as maintenance and reliever therapy.
C Stepping down treatment  Consider stepping down treatment once good asthma control has been achieved and maintained for 3 months, to find the lowest treatment that controls both symptoms and exacerbations, and minimizes side-effects.
C Stepping down treatment  Choose an appropriate time for step-down (no respiratory infection, patient not travelling, not pregnant).  Document baseline status (symptom control and lung function), provide a written asthma action plan, monitor closely and book a follow-up visit.
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*Off-label; data only with budesonide-formoterol (bud-form) †Off-label; separate or combination ICS and SABA inhalers STEP 2 Daily low dose inhaled corticosteroid (ICS), or as-needed low dose ICS-formoterol * STEP 3 Low dose ICS-LABA STEP 4 Medium dose ICS-LABA Leukotriene receptor antagonist (LTRA), or low dose ICS taken whenever SABA taken † As-needed low dose ICS-formoterol * As-needed short-acting β2 -agonist (SABA) Medium dose ICS, or low dose ICS+LTRA # High dose ICS, add-on tiotropium, or add-on LTRA # Add low dose OCS, but consider side-effects As-needed low dose ICS-formoterol ‡ STEP 5 High dose ICS-LABA Refer for phenotypic assessment ± add-on therapy, e.g.tiotropium, anti-IgE, anti-IL5/5R, anti-IL4R Symptoms Exacerbations Side-effects Lung function Patient satisfaction Confirmation of diagnosis if necessary Symptom control & modifiable risk factors (including lung function) Comorbidities Inhaler technique & adherence Patient goals Treatment of modifiable risk factors & comorbidities Non-pharmacological strategies Education & skills training Asthma medications 1© Global Initiative for Asthma, www.ginasthma.org STEP 1 As-needed low dose ICS-formoterol * Low dose ICS taken whenever SABA is taken† ‡ Low-dose ICS-form is the reliever for patients prescribed bud-form or BDP-form maintenance and reliever therapy # Consider adding HDM SLIT for sensitized patients with allergic rhinitis and FEV >70% predicted PREFERRED CONTROLLER to prevent exacerbations and control symptoms Other controller options Other reliever option PREFERRED RELIEVER Box 3-5A Adults & adolescents 12+ years Personalized asthma management: Assess, Adjust, Review response Asthma medication options: Adjust treatment up and down for individual patient needs
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 Many guidelines over the past 50 years have recommended SABA as the first line to treat asthma and to move on to ICS when that proved to be unsuccessful in controlling symptoms.  For safety, GINA no longer recommends SABA only treatment for Step 1  This decision was based on evidence that SABA-only treatment increases the risk of severe exacerbations, and that adding any ICS significantly reduces the risk.
Background to changes in 2019 Risks of SABA-only treatment Regular or frequent use of SABA is associated with adverse effects  β-receptor downregulation, decreased bronchoprotection, rebound hyperresponsiveness, decreased bronchodilator response (Hancox, Respir Med 2000)  Increased allergic response, and increased eosinophilic airway inflammation (Aldridge, AJRCCM 2000).
 Higher use of SABA is associated with adverse clinical outcomes :  Dispensing of ≥3 canisters per year (average 1.7 puffs/day) is associated with higher risk of emergency department presentations (Stanford, AAAI 2012)  Dispensing of ≥12 canisters per year is associated with higher risk of death (Suissa, AJRCCM 1994)
Background to changes in 2019 Risks of Mild Asthma  Epidemiological data shows that mild asthma accounts for 50 -75% of the total population of asthma patients.  Mild asthma, often termed mild intermittent or mild persistent asthma, is defined by the Global Initiative in Asthma (GINA) management strategy as patients who meet the criteria for step 1 and step 2 treatment strategies.  Although these patients have fewer symptoms, they are the main and largest subgroup of asthma patients.
 “There is a perception that infrequent symptoms mean low-risk, but the evidence is that patients with mild asthma still have severe attacks”  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  15–20% of adults dying of asthma
 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 SABA-only treatment in patients eligible for Step 2 therapy (O’Byrne, NEJMed Step 1 – ‘preferred’ controller option
Low dose ICS taken whenever SABA is taken (off-label)  As Separate or Combination ICS and SABA inhalers Evidence  Indirect evidence from studies in patients eligible for Step 2 treatment (BEST, TREXA, BASALT) Daily Low dose ICS is no longer listed as a Step 1 option  This was included in GINA 2014 -2018, but with high probability of adherence  Now replaced by more feasible as-needed controller options for Step 1 Step 1 - other controller option
 The new GINA 2019 asthma treatment recommendations represent significant shifts in asthma management at Steps 1 and 2 of the 5 treatment steps.  The report acknowledges an emerging body of evidence suggesting the non safety of SABAs overuse in the absence of concomitant controller medications.
 The new GINA 2019 does not support SABA-only therapy in mild asthma and has included new off-label recommendations such as :  Symptom-driven (as-needed) low dose ICS-formoterol or  “Low dose ICS taken whenever SABA is taken”.  These recommendations represent a clear deviation from decades of clinical practice mandating the use of symptom-driven SABA treatment alone in those with mild asthma.
Step 2 – there are two ‘preferred’ controller options 1- Regular low dose ICS with as-needed SABA  For patients requiring Step 2 treatment, GINA 2019 has retained the previous recommendation for preferred controller treatment as daily low dose ICS with as needed SABA .  This is based on cumulative evidence demonstrating that regular low dose use substantially reduces asthma symptoms, increases lung function, improves QoL and reduces risks of severe exacerbations, hospitalizations or death.
Step 2 – there are two ‘preferred’ controller options 1- Regular low dose ICS with as-needed SABA  For patients requiring Step 2 treatment, GINA 2019 has retained the previous recommendation for preferred controller treatment as daily low dose ICS with as needed SABA .  This is based on cumulative evidence demonstrating that regular low dose use substantially reduces asthma symptoms, increases lung function, improves QoL and reduces risks of severe exacerbations, hospitalizations death.  Poor adherence with ICS is common in mild asthma , and that this would expose patients to the risks of SABA-only treatment .
Step 2 – there are two ‘preferred’ controller options 2- As-needed low dose ICS-formoterol (off-label; all evidence with budesonide- formoterol)  Another preferred controller option in Step 2 in the 2019 GINA recommendations is the newly included, as-needed low dose ICS-formoterol label) combination which reflects the clinical concern of non-adherence to low dose ICSs in people with milder forms of asthma (needing Step 1 and Step treatment) and resultant exposure to SABA monotherapy with such non- adherence,
Step 2 – other controller options 1- Low dose ICS taken whenever SABA taken (off-label, separate or combination inhalers) 2-Another option: leukotriene receptor antagonist (less effective for exacerbations)
113 Thank you

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Asthma Mangement: Time for a New Approach

  • 1.
  • 3.
  • 4.
  • 5.
  • 7.
  • 8.
    Step 2 Step3 Step 4 Step 5Step 1 Asthma Education Enviromental Control As needed rapid acting 2 agonists As needed rapid acting 2 agonists Controller options Select one Select one Add one or more Add one or both Low-dose ICS Low-dose ICS + LABA Medium or high dose ICS+ LABA Oral steroid LTRA Medium or high dose ICS LTRA Anti-IgE Low-dose ICS + LTRA Theophylline Low-dose ICS + Theophylline INCREASEREDUCE TREATMENT STEPS GINA 2013 As needed rapid acting B2-agonist
  • 9.
  • 10.
  • 11.
  • 12.
    GINA 2017, Box3-2 Diagnosis Symptom control & risk factors (including lung function) Inhaler technique & adherence Patient preference Asthma medications Non-pharmacological strategies Treat modifiable risk factors Symptoms Exacerbations Side-effects Patient satisfaction Lung function The control-based asthma management cycle
  • 14.
    14 • How? – Asthmaseverity is assessed retrospectively from the level of treatment required to control symptoms and exacerbations • When? – Assess asthma severity after patient has been on controller treatment for several months – Severity is not static – it may change over months or years, or as different treatments become available Assessment of Asthma Severity
  • 15.
    15 Categories of asthmaseverity – Mild asthma: Well-controlled with Steps 1 or 2 (as-needed SABA or low dose ICS) – Moderate asthma: Well-controlled with Step 3 (low-dose ICS/LABA) – Severe asthma: Requires Step 4/5 (moderate or high dose ICS/LABA ± add-on), or remains uncontrolled despite this treatment
  • 16.
  • 17.
  • 18.
     Maintain control by steppingup treatment as necessary. How do we apply the stepwise approach?
  • 19.
    Stepping down Ensure regularreview of patients as treatment is stepped down Decide which drug to step down first and at what rate When control is good, step down.
  • 20.
  • 21.
    Step 1 treatmentis for patients with symptoms <twice/month Previously, no controller was recommended for Step 1, i.e. SABA-only treatment was ‘preferred’ GINA 2018 – main treatment figure
  • 23.
     Preferred option:as-needed inhaled short-acting beta2-agonist (SABA)  SABAs are highly effective for relief of asthma symptoms  However …. there is insufficient evidence about the safety of treating asthma SABA alone  This option should be reserved for patients with infrequent symptoms (less than twice a month) of short duration, and with no risk factors for exacerbations  Other options  Consider adding regular low dose inhaled corticosteroid (ICS) for patients at risk of exacerbations Step 1 – as-needed reliever inhaler 2018 GINA 2017
  • 25.
     Daily Lowdose ICS has been suggested by GINA since 2014 in step1 to reduce the risk of severe exacerbations .  However, patients with symptoms less than twice a month are unlikely to take ICS regularly, leaving them exposed to the risks of SABA-only treatment.
  • 28.
     Preferred option:regular low dose ICS with as-needed inhaled SABA  Low dose ICS reduces symptoms and reduces risk of exacerbations and asthma- related hospitalization and death  Other options  Leukotriene receptor antagonists (LTRA) with as-needed SABA  Less effective than low dose ICS  May be used for some patients with both asthma and allergic rhinitis, or if patient will not use ICS  Combination low dose ICS/long-acting beta2-agonist (LABA) with as-needed SABA  Reduces symptoms and increases lung function compared with ICS  More expensive, and does not further reduce exacerbations  Intermittent ICS with as-needed SABA for purely seasonal allergic asthma with no interval symptoms  Start ICS immediately symptoms commence, and continue for 4 weeks after pollen season ends Step 2 – Low dose controller + as-needed SABA 2018 GINA 2017
  • 30.
  • 31.
    GINA 2017, Box3-5, Step 1 (4/8) Start controller treatment early – For best outcomes, initiate controller treatment as early as possible after making the diagnosis of asthma Indications for regular low-dose ICS - any of : – Asthma symptoms more than twice a month – Waking due to asthma more than once a month – Any asthma symptoms plus any risk factors for exacerbations Recommended Initial Treatment Step
  • 32.
    Treatment Options foradult Patients Not Controlled on low dose Inhaled Steroids Patients not controlled on Low dose ICS Increase the dose of inhaled steroid Add leukotriene receptor antagonists Add long-acting beta2-agonists Add theophylline
  • 34.
    35 Step 3 –one or two controllers + as-needed inhaled reliever
  • 36.
  • 38.
  • 39.
  • 40.
    Symbicort SMART Symbicort MaintenanceAnd Reliever Therapy Formoterol Budesonide SABA
  • 41.
  • 42.
  • 43.
  • 44.
  • 45.
  • 47.
  • 48.
     Combination inhalersof salmeterol with an ICS, such as Seretide, are not suitable for single inhaler maintenance and reliever therapy.  Salmeterol should not be used for the relief of acute asthma symptoms because it has a significantly slower onset of action than either formoterol, salbutamol or terbutaline. 49
  • 50.
    GINA 2015 –changes to Steps 4 and 5 © Global Initiative for AsthmaGINA 2015, Box 3-5, Steps 4 and 5 *For children 6-11 years, theophylline is not recommended, and preferred Step 3 is medium dose ICS **For patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy # Tiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years. Other controller options RELIEVER STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 Low dose ICS Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* Med/high dose ICS Low dose ICS+LTRA (or + theoph*) As-needed short-acting beta2-agonist (SABA) Low dose ICS/LABA* Med/high ICS/LABA Refer for add-on treatment e.g. anti-IgE PREFERRED CONTROLLER CHOICE Add tiotropium# High dose ICS + LTRA (or + theoph*) Add tiotropium# Add low dose OCS As-needed SABA or low dose ICS/formoterol**
  • 53.
    55 • Add-on tiotropiumby soft-mist inhaler is a new ‘other controller option’ for Steps 4 and 5, in patients ≥ 18 years with history of exacerbations What’s new in GINA 2015
  • 54.
    © Global Initiativefor Asthma© Global Initiative for Asthma Step 4 – two or more controllers + as-needed inhaled reliever GINA 2016, Box 3-5, Step 4 (7/8) Other controller options RELIEVER STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 Low dose ICS Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* Med/high dose ICS Low dose ICS+LTRA (or + theoph*) As-needed short-acting beta2-agonist (SABA) Low dose ICS/LABA** Med/high ICS/LABA PREFERRED CONTROLLER CHOICE *Not for children <12 years **For children 6-11 years, the preferred Step 3 treatment is medium dose ICS #For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy  Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations Refer for add-on treatment e.g. tiotropium,* omalizumab, mepolizumab* As-needed SABA or low dose ICS/formoterol# Add tiotropium* High dose ICS + LTRA (or + theoph*) Add low dose OCS
  • 55.
    57 Consider adding sublingualimmunotherapy (SLIT) in adult HDM-sensitive patients with allergic rhinitis and asthma who have exacerbations despite ICS treatment, provided FEV1 is 70% predicted In such patients with exacerbations despite taking step 3 or step 4 therapy (according to GINA), SLIT can now be considered as add on therapy UPDATED 2017
  • 56.
    GINA 2018 –main treatment figure
  • 57.
    © Global Initiativefor Asthma Step 5 – higher level care and/or add-on treatment GINA 2016, Box 3-5, Step 5 (8/8) Other controller options RELIEVER STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 Low dose ICS Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* Med/high dose ICS Low dose ICS+LTRA (or + theoph*) As-needed short-acting beta2-agonist (SABA) Low dose ICS/LABA** Med/high ICS/LABA PREFERRED CONTROLLER CHOICE *Not for children <12 years **For children 6-11 years, the preferred Step 3 treatment is medium dose ICS #For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy  Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations Refer for add-on treatment e.g. tiotropium,* omalizumab, mepolizumab* As-needed SABA or low dose ICS/formoterol# Add tiotropium* High dose ICS + LTRA (or + theoph*) Add low dose OCS
  • 58.
    © Global Initiativefor Asthma Preferred option is referral for specialist investigation and consideration of add-on treatment  If symptoms uncontrolled or exacerbations persist despite Step 4 check inhaler technique and adherence before referring  Add-on tiotropium for patients ≥12 years with history of exacerbations  Add-on anti-IgE (omalizumab) for patients with severe allergic asthma  Add-on anti-IL5 (mepolizumab (SC) or reslizumab (IV)) for severe eosinophilic asthma (≥12 yrs) Other add-on treatment options at Step 5 include:  Sputum-guided treatment: this is available in specialized centers; reduces exacerbations and/or corticosteroid dose  Add-on low dose oral corticosteroids (≤7.5mg/day prednisone equivalent): this may benefit some patients, but has significant systemic side-effects. Assess and monitor for osteoporosis Step 5 – higher level care and/or add-on treatment GINA 2017 UPDATED 2017
  • 60.
    ClAdd-on Controller Medication Long-acting anticholinergic (At Step 4 or 5 with a history of exacerbations despite ICS ± LABA) : Tiotropium  Anti-IgE (with severe allergic asthma uncontrolled on high dose ICS- LABA): Omalizumab
  • 61.
    ClAdd-on Controller Medication Anti-IL5 & Anti-IL5R (Severe eosinophilic asthma uncontrolled on high dose ICS-LABA)  Mepolizumab & Reslizumab  Benralizumab  Anti-IL4R (Severe eosinophilic asthma uncontrolled on high dose ICS-LABA, or requiring maintenance OCS)  Dupilumab
  • 64.
  • 65.
    ClStarting Asthma Treatment ICS-containing treatment should be initiated as soon as possible after the diagnosis of asthma is made.  Consider starting at a higher step (e.g. medium/high dose ICS, or low-dose ICS-LABA) if on most days the patient has troublesome asthma symptoms; or is waking from asthma once or more a week.
  • 66.
    ClStarting Asthma Treatment If the initial asthma presentation is with severely uncontrolled asthma, or with an acute exacerbation, give a short course of OCS and start regular controller treatment (e.g. medium dose ICS-LABA).  Consider stepping down after asthma has been well controlled for 3 months. However, in adults and adolescents, ICS should not be completely stopped.
  • 67.
  • 68.
    CAfter Starting InitialController Treatment  Review response after 2–3 months, or according to clinical urgency.  Review for ongoing treatment and other key management issues.  Consider step down when asthma has been well controlled for 3 months.
  • 69.
    C Reviewing response andadjusting treatment  Patients should preferably be seen 1–3 months after starting treatment  Every 3–12 months after that, but in pregnancy, asthma should be reviewed every 4–6 weeks.  After an exacerbation, a review visit within 1 week should be scheduled.
  • 70.
    C Stepping up treatment Sustained step-up (for at least 2–3 months): if symptoms and/or exacerbations persist despite 2–3 months of controller treatment, assess the following common issues before considering a step-up • Incorrect inhaler technique • Poor adherence • Modifiable risk factors • Comorbid conditions
  • 71.
    C Stepping up treatment Short-term step-up (for 1–2 weeks) by clinician or by patient with written asthma action plan, e.g. during viral infection or allergen exposure.  Day-to-day adjustment by patient for those who prescribed as-needed low dose ICS formoterol for mild asthma, or low dose ICS-formoterol as maintenance and reliever therapy.
  • 72.
    C Stepping down treatment Consider stepping down treatment once good asthma control has been achieved and maintained for 3 months, to find the lowest treatment that controls both symptoms and exacerbations, and minimizes side-effects.
  • 73.
    C Stepping down treatment Choose an appropriate time for step-down (no respiratory infection, patient not travelling, not pregnant).  Document baseline status (symptom control and lung function), provide a written asthma action plan, monitor closely and book a follow-up visit.
  • 74.
  • 75.
  • 76.
  • 77.
  • 80.
  • 82.
    *Off-label; data onlywith budesonide-formoterol (bud-form) †Off-label; separate or combination ICS and SABA inhalers STEP 2 Daily low dose inhaled corticosteroid (ICS), or as-needed low dose ICS-formoterol * STEP 3 Low dose ICS-LABA STEP 4 Medium dose ICS-LABA Leukotriene receptor antagonist (LTRA), or low dose ICS taken whenever SABA taken † As-needed low dose ICS-formoterol * As-needed short-acting β2 -agonist (SABA) Medium dose ICS, or low dose ICS+LTRA # High dose ICS, add-on tiotropium, or add-on LTRA # Add low dose OCS, but consider side-effects As-needed low dose ICS-formoterol ‡ STEP 5 High dose ICS-LABA Refer for phenotypic assessment ± add-on therapy, e.g.tiotropium, anti-IgE, anti-IL5/5R, anti-IL4R Symptoms Exacerbations Side-effects Lung function Patient satisfaction Confirmation of diagnosis if necessary Symptom control & modifiable risk factors (including lung function) Comorbidities Inhaler technique & adherence Patient goals Treatment of modifiable risk factors & comorbidities Non-pharmacological strategies Education & skills training Asthma medications 1© Global Initiative for Asthma, www.ginasthma.org STEP 1 As-needed low dose ICS-formoterol * Low dose ICS taken whenever SABA is taken† ‡ Low-dose ICS-form is the reliever for patients prescribed bud-form or BDP-form maintenance and reliever therapy # Consider adding HDM SLIT for sensitized patients with allergic rhinitis and FEV >70% predicted PREFERRED CONTROLLER to prevent exacerbations and control symptoms Other controller options Other reliever option PREFERRED RELIEVER Box 3-5A Adults & adolescents 12+ years Personalized asthma management: Assess, Adjust, Review response Asthma medication options: Adjust treatment up and down for individual patient needs
  • 83.
  • 86.
     Many guidelinesover the past 50 years have recommended SABA as the first line to treat asthma and to move on to ICS when that proved to be unsuccessful in controlling symptoms.  For safety, GINA no longer recommends SABA only treatment for Step 1  This decision was based on evidence that SABA-only treatment increases the risk of severe exacerbations, and that adding any ICS significantly reduces the risk.
  • 87.
    Background to changesin 2019 Risks of SABA-only treatment Regular or frequent use of SABA is associated with adverse effects  β-receptor downregulation, decreased bronchoprotection, rebound hyperresponsiveness, decreased bronchodilator response (Hancox, Respir Med 2000)  Increased allergic response, and increased eosinophilic airway inflammation (Aldridge, AJRCCM 2000).
  • 88.
     Higher useof SABA is associated with adverse clinical outcomes :  Dispensing of ≥3 canisters per year (average 1.7 puffs/day) is associated with higher risk of emergency department presentations (Stanford, AAAI 2012)  Dispensing of ≥12 canisters per year is associated with higher risk of death (Suissa, AJRCCM 1994)
  • 89.
    Background to changesin 2019 Risks of Mild Asthma  Epidemiological data shows that mild asthma accounts for 50 -75% of the total population of asthma patients.  Mild asthma, often termed mild intermittent or mild persistent asthma, is defined by the Global Initiative in Asthma (GINA) management strategy as patients who meet the criteria for step 1 and step 2 treatment strategies.  Although these patients have fewer symptoms, they are the main and largest subgroup of asthma patients.
  • 90.
     “There isa perception that infrequent symptoms mean low-risk, but the evidence is that patients with mild asthma still have severe attacks”  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  15–20% of adults dying of asthma
  • 93.
     Step 1is 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 SABA-only treatment in patients eligible for Step 2 therapy (O’Byrne, NEJMed Step 1 – ‘preferred’ controller option
  • 94.
    Low dose ICStaken whenever SABA is taken (off-label)  As Separate or Combination ICS and SABA inhalers Evidence  Indirect evidence from studies in patients eligible for Step 2 treatment (BEST, TREXA, BASALT) Daily Low dose ICS is no longer listed as a Step 1 option  This was included in GINA 2014 -2018, but with high probability of adherence  Now replaced by more feasible as-needed controller options for Step 1 Step 1 - other controller option
  • 95.
     The newGINA 2019 asthma treatment recommendations represent significant shifts in asthma management at Steps 1 and 2 of the 5 treatment steps.  The report acknowledges an emerging body of evidence suggesting the non safety of SABAs overuse in the absence of concomitant controller medications.
  • 96.
     The newGINA 2019 does not support SABA-only therapy in mild asthma and has included new off-label recommendations such as :  Symptom-driven (as-needed) low dose ICS-formoterol or  “Low dose ICS taken whenever SABA is taken”.  These recommendations represent a clear deviation from decades of clinical practice mandating the use of symptom-driven SABA treatment alone in those with mild asthma.
  • 98.
    Step 2 –there are two ‘preferred’ controller options 1- Regular low dose ICS with as-needed SABA  For patients requiring Step 2 treatment, GINA 2019 has retained the previous recommendation for preferred controller treatment as daily low dose ICS with as needed SABA .  This is based on cumulative evidence demonstrating that regular low dose use substantially reduces asthma symptoms, increases lung function, improves QoL and reduces risks of severe exacerbations, hospitalizations or death.
  • 99.
    Step 2 –there are two ‘preferred’ controller options 1- Regular low dose ICS with as-needed SABA  For patients requiring Step 2 treatment, GINA 2019 has retained the previous recommendation for preferred controller treatment as daily low dose ICS with as needed SABA .  This is based on cumulative evidence demonstrating that regular low dose use substantially reduces asthma symptoms, increases lung function, improves QoL and reduces risks of severe exacerbations, hospitalizations death.  Poor adherence with ICS is common in mild asthma , and that this would expose patients to the risks of SABA-only treatment .
  • 100.
    Step 2 –there are two ‘preferred’ controller options 2- As-needed low dose ICS-formoterol (off-label; all evidence with budesonide- formoterol)  Another preferred controller option in Step 2 in the 2019 GINA recommendations is the newly included, as-needed low dose ICS-formoterol label) combination which reflects the clinical concern of non-adherence to low dose ICSs in people with milder forms of asthma (needing Step 1 and Step treatment) and resultant exposure to SABA monotherapy with such non- adherence,
  • 101.
    Step 2 –other controller options 1- Low dose ICS taken whenever SABA taken (off-label, separate or combination inhalers) 2-Another option: leukotriene receptor antagonist (less effective for exacerbations)
  • 111.