Asthma Update. Disclosure. Marium Mariko Yabe-Gill, MD, MBBS Assistant Professor Pediatric Pulmonology/Allergy. No conflict of interest.

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1 Asthma Update Marium Mariko Yabe-Gill, MD, MBBS Assistant Professor Pediatric Pulmonology/Allergy Disclosure No conflict of interest Objective Asthma diagnosis and management ( National Asthma Education and Prevention Program 2007) New developments in asthma management

2 NAEPP 2007 Asthma Diagnosis Asthma Diagnosis (by history, the patient must meet three criteria): Symptoms of asthma occur in response to an allergen trigger or airway irritant (airway hyperreactivity) Repeated episodes of symptoms (recurrence) Response to treatment (reversibility) measured objectively by spirometry with a significant increase postbronchodilator or relief of symptoms (EPR3) 4 Components of Asthma Care Assessment and Monitoring Education Control Environmental Factors and Comorbid Conditions Use of Medications

3 Assessment and Monitoring Initial Visit: -Assess asthma severity to initiate treatment Assessment and Monitoring Initial Visit: -Assess asthma severity to initiate treatment Assessment and Monitoring Follow-Up Visits -Assess asthma control to determine if therapy should be adjusted -Assess proper inhalation technique, written asthma action plan, patient adherence and concerns -Obtain lung function measures by spirometry at least every 1-2 years; more frequently if asthma is not well controlled -Determine if therapy should be adjusted; step up or down Scheduling follow up care: -While gaining control q2-6 weeks -Monitoring control q1-6 months -Every 3 months if step down in therapy is anticipated

4 Assessing control and adjusting therapy Assessing control and adjusting therapy 4 Components of Asthma Care Assessment and Monitoring Education Control Environmental Factors and Comorbid Conditions Use of Medications

5 Asthma Education Teach patients how to manage their asthma -Recognize signs of worsening asthma -Taking medication correctly -Understanding long-term control and quick-relief medications -Avoiding environmental factors that worsen asthma Develop a written asthma action plan in partnership with the family -Teach patients how to use the action plan to take daily medications, adjust medications in response to worsening asthma, seek medical care -Encourage adherence to the asthma action plan -Boost confidence when good control has been achieved 4 Components of Asthma Care Assessment and Monitoring Education Control Environmental Factors and Comorbid Conditions Use of Medications Recommend ways to control exposure to allergens, irritants and pollutants that Control Environmental Factors and Comorbid Conditions make asthma worse Treat comorbid conditions that make asthma worse reflux, obesity, obstructive sleep apnea, rhinitis/sinusitis, stress, depression, allergic bronchopulmonary aspergillosis Consider flu vaccination in all patients > 6months of age

6 4 Components of Asthma Care Assessment and Monitoring Education Control Environmental Factors and Comorbid Conditions Use of Medications Use of Medications Select medications and delivery devices that meet patient s needs and circumstances Review medications, technique and adherence at each follow-up visit

7 Updates in the asthma world New guidelines regarding endocrine effects of long-term inhaled glucocorticoids in children ( Feb 2016) Safety of fluticasone-salmeterol combination therapy in asthma ( March 2016) New monoclonal antibody against IL-5 approved for severe eosinophilic asthma ( Nov 2015) Use of azithromycin to prevent or shorten duration of symptoms in young children with recurrent wheeze/asthma ( January 2016) New guidelines regarding endocrine effects of long-term inhaled glucocorticoids in children

8 Dose and Formulation Effects of ICS s Primary Recommendations -For most ICS s, respiratory effectiveness correlates with systemic bioavailability therefore, devices that result in greater lung deposition should be used at lower doses -Healthy lungs or healthier asthmatic lungs promote better absorption than in states of active disease and airflow obstruction therefore, step-down therapy is recommended once good control is achieved Effects on the HPA axis Primary Conclusions -HPA axis suppression is a rare but the most serious potential ICS adverse effect in children taking standard dosages ( level of evidence 1) Primary Recommendations -children taking ICS s with hypoglycemia or altered mental status should be urgently evaluated for adrenal insufficiency and treated, if necessary ( grade A recommendation) -Symptoms of AI in patients taking ICS s are similar to those seen with other forms of ACTH insufficiency anorexia, weight loss, growth failure, hypoglycemia -Symptoms of adrenal crisis hypotension, lethargy and hypoglycemia should provoke immediate testing and stress doses of corticosteroids

9 Effects on the HPA axis Primary Recommendations -Testing is recommended in certain categories of asymptomatic patient s taking ICS s such as high dose daily ICS s, those requiring periodic oral steroids or additional long-term intra-nasal steroid treatment with a low BMI ( grade C recommendation) -Children with HPA axis suppression may need a daily corticosteroid, if symptomatic or only at times of illness or physical stress, if asymptomatic -Pulmonologist/allergist may consider decreasing ICS dose by adding a corticosteroid-sparing agent i.e. leukotriene receptor antagonist Effects on Linear Growth Primary Conclusions -ICS s have minor and short-term effects on growth. They may have very mild but persistent long-term effects ( level of evidence 2) Primary Recommendations - Minor growth risks are outweighed by the respiratory benefits of ICS s ( grade B recommendation) - Anthracopoulos et al performed a large, prospective, open-label study of both budesonide and fluticasone that found growth reduction in both groups in the first 6-12 mths. However, patient s heights returned to baseline by months - Most long-term studies have found that adult heights attained in treated and non-treated asthmatic children did not differ significantly - Few studies have found a minor effect on final height of ~1cm Anthracopoulos et al. Pediatric Pulmonology 42: ( 2007) Effects on Bone Mineral Density Primary Conclusions -ICS s have mild effects on bone mineral density that do not reach clinical significance ( level of evidence 2) -Measures to ensure Vit D sufficiency may ameliorate the negative BMD effects of ICS s ( level of evidence 4) Primary Recommendations -Routine dual energy X-ray absorptiometry screening in children taking ICS s without major risk factors is not indicated ( grade B recommendation) -Routine vitamin D supplementation of IU/day without monitoring serum Vit D levels and ensuring adequate dietary intake of calcium mg/d is indicated in lower risk ICS users ( grade C recommendation) -Threshold dose of ICS s that cause bone mineral loss has not been defined

10 Effects of Inhaled Corticosteroids on Glucose Metabolism Primary Conclusions -Effects of ICS s on glucose levels are dose-dependent -Effects of ICS s on glucose levels are of concern in patients who have a previous diagnosis of DM and are at high risk of type 2 DM ( level of evidence 4) Primary Recommendations -Patients at high risk of developing type 2 DM from obesity and another risk factor i.e. ethnicity and/or +ve family history, should be tested after ICS tx is initiated or increased ( grade D recommendation) -Referral to an endocrinologist if HbA1C >6.0% or fasting glucose > 100mg/dl -If there is worsening blood glucose control in a diabetic after initiation of an ICS, adjustment of DM medications may be needed Endocrine Effects of Inhaled Corticosteroids in Children.. In summary HPA axis suppression is a potentially life-threatening adverse effect of ICS s. Adrenal function should be tested in symptomatic patients, those with growth attenuation and, high risk asymptomatic patients Data on linear growth and BMD is reassuring but height attainment should be monitored Deteriorating blood glucose control in patients with preexisting diabetes type 1 and 2 is common with ICS s DM medication dose adjustments are likely required at the initiation of ICS tx and with dose increments Safety of fluticasone-salmeterol combination therapy in asthma

11 Serious Asthma Events with Fluticasone plus Salmeterol versus Background Fluticasone Alone -Safe and appropriate use of long-acting beta agonists ( LABA s) for the treatment of asthma is controversial -Two large clinical trials ( Serevent Nationwide Surveillance Trial, SNS and Salmeterol Multicenter Asthma Research Trial, SMART) found a potential risk of serious asthma-related events associated with LABAs -This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone Methods -Multicenter, randomized, double-blinded study -Adolescent ( > 12 years) and adult patients with persistent asthma were assigned to receive fluticasone with salmeterol or fluticasone alone for 26 weeks at 710 centers in 33 countries -All patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month -Exclusion criteria: life-threatening asthma, cigarette smoking for > 10 pack years or unstable asthma

12 Serious Asthma Events with Fluticasone plus Salmeterol versus Results Fluticasone Alone -11, 679 patients were enrolled -67 had serious asthma-related events -36 events in 34 patients in the fluticasone-salmeterol group -38 events in 33 patients in the fluticasone only group -No asthma related deaths ; 2 patients in the fluticasone only group underwent asthmarelated intubation -Risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone only group. This decreased risk was most prominent in adolescents in whom it was 35% lower -At least one severe asthma exacerbation occurred in 8% patients in the fluticasonesalmeterol group versus 10% in the fluticasone-only group ( P <0.001) Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone Conclusions - Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone - Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than those in the fluticasone only group New monoclonal antibody against IL-5 approved for severe eosinophilic asthma

13 New monoclonal antibody against IL-5 approved for severe eosinophilic asthma Mepolizumab- a monoclonal antibody that binds to and inactivates interleukin-5 has been FDA approved as an add-on, maintenance treatment for severe eosinophilic asthma in patients age 12 and older One marker of an eosinophilic phenotype is an absolute eosinophilic count in serum of >150/microL Mepolizumab is administered subcutaneously at 4 week intervals New monoclonal antibody against IL-5 approved for severe eosinophilic asthma New monoclonal antibody against IL-5 approved for severe eosinophilic asthma Oral glucocorticoid sparing effect of Mepolizumab in eosinophilic asthma -Randomized, double-blinded trial involving 135 patients with severe eosinophilic asthma who had at least a 6 mth history of maintenance tx with systemic glucocorticoids, 5-35mg/day -Mean age range Median percentage reduction from baseline in glucocorticoid dose was 50% in the mepolizumab group compared with no reduction in the placebo group ( P=0.007) -Patients in the mepolizumab group despite, being on a lower glucocorticoid dose had a reduction of 32% in the annual rate of exacerbations ( P=0.004) and a reduction of 0.52 points with respect to asthma symptoms as measured on the Asthma Control Questionnaire ( P=0.004) -Safety profile of mepolizumab was same as placebo

14 Use of azithromycin to prevent or shorten duration of symptoms in young children with recurrent wheeze/asthma Use of azithromycin to prevent or shorten duration of symptoms in young children with recurrent wheeze/asthma The potential utility of macrolides in the treatment of recurrent wheeze/ asthma is under investigation, given their anti-inflammatory and antimicrobial effects against Mycoplasma pneumoniae and Chlamydia pneumonia Randomized, double-blind, placebo-controlled, parallel-group trial conducted across 9 academic US medical centers in the National Heart, Lung and Blood Institute s AsthmaNet network 607 children, aged months with histories of recurrent, severe LRTIs Children were randomly assigned to oral azithromycin ( 12mg/kg/day) or placebo for 5 days in addition to albuterol Primary outcome measure was the number of RTIs not progressing to a severe LRTI ( defined as needing a Rx of oral corticosteroids) Secondary outcome measure- adverse events and presence of azithromycin-resistant organisms in oropharyngeal samples

15 Azithromycin significantly reduced the risk of progressing to severe LRTI vs placebo ( hazard ratio 0.64) Induction of azithromycin-resistant organisms and adverse events were infrequently observed There was no difference in urgent care utilization, ER visits or hospitalizations Use of azithromycin to prevent or shorten duration of symptoms in young children with recurrent wheeze/asthma Lancet Respir Med 2016:4:19-26 Randomized, double blind, placebo-controlled trial 72 children, aged 1-3 years with recurrent asthma-like sx Each episode of asthma-like symptoms lasting at least 3 days was randomly allocated to a 3 day course of azithromycin( 10mg/kg/day) or placebo Mean duration of the episode was 3.4 days in azithromycin group versus 7.7 days in the placebo group Azithromycin caused a significant shortening of the episode 63.3%, p< Effect size increased with early initiation of treatment. Reduction in episode duration of 83% if tx was initiated before day 6 vs. 36% is initiated on day 6 or after ( p<0.0001) No difference in adverse effects for treatment versus placebo group ( p=0.30) Emergence of bacterial resistance patterns after treatment was not investigated Lancet Respir Med 2016:4:19-26

16 Use of azithromycin to prevent or shorten duration of symptoms in young children with recurrent wheeze/asthma Further studies are needed to understand the exact mechanisms by which azithromycin helps reduce the progression of a RTI to LRTI and decrease duration of a respiratory episode Also, further studies are needed to define subpopulations that would most benefit from use of azithromycin, given concerns of antibiotic resistance/adverse events with widespread use References Endocrine Effects of Inhaled Corticosteroids in Children. JAMA Pediatrics. Volume 170, Number 2 ( 2016) Growth Deceleration of Children on Inhaled Corticosteroids Is Compensated for After the First 12 months of Treatment. Pediatric Pulmonology 42: ( 2007) Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. NEJM oa ( 2016) Oral Glucocorticoid Sparing Effect of Mepolizumab in Eosinophilic Asthma. NEJM 4;317: ( 2014) Early Administration of azithromycin and prevention of severe lower respiratory tract illnesses in preschool children with a history of such illnesses. JAMA Volume 314, Number 19 ( 2015) Azithromycin for episodes with asthma-like symptoms in young children aged 1-3 years: A randomized, double-blind, placebo controlled trial. Lancet Respir Med 4:19-26 ( 2016) Mepolizumab versus placebo for asthma. Cochran database systematic review. 7: CD ( 2015) An update on emerging drugs for asthma. Expert Opin Emerg Drugs 17;37-42 ( 2012) Mepolizumab for severe eosinophilic asthma: Multicenter, double-blind, placebo control trial. Lancet. 380: ( 2012) International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Resp J 43: ( 2014) Regular treatment with Salmeterol for chronic asthma: Serious adverse events. Cochran database systematic review 3: CD ( 2008) The Salmeterol Multicenter Asthma Research Trial: A comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus Salmeterol. Chest 129:15-26 ( 2006) Serevent nationwide surveillance study: Comparison of salmeterol with salbutamol in asthmatic patients who require regular broncho-dilator treatment. BMJ 306: ( 1993) The use of beta agonists and the risk of death and near death from asthma. NEJM 326:501-6 ( 1992) Meta analysis of the risk of mortality with salmeterol and affect of concomitant neocortical steroid therapy. Thorax 65:39-43 ( 2010) Age and risks of FDA approved long-acting beta-2 adrenergic receptor agonist. Pediatrics 128(5):e ( 2011) Guidelines from the National Asthma Education and Prevention Program 2007

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