December 6, 2010 Pediatric Severe Asthma
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1 December 6, 2010 Pediatric Severe Asthma Lanny J. Rosenwasser, M.D. Dee Lyons/Missouri Endowed Chair in Immunology Research Professor of Pediatrics Allergy-Immunology Division Childrens Mercy Hospital Kansas City, Missouri Professor of Pediatrics, Medicine and Basic Science University of Missouri Kansas City School of Medicine
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3 Disclosure Statement Lanny J. Rosenwasser, MD RESEARCH STUDIES Alcon,A-Z, GlaxoSmithKline, MBBH/MacArthur Foundation, National Institutes of Health CONSULTANT Abbott Corp, Alcon, Alexion, Altana Pharmaceuticals, A-Z,Biogen Idec Corp, Genentech, GlaxoSmithKline, Merck, Novartis, Sanofi-Aventis SPEAKERS BUREAU Alcon, Banyu Pharmaceuticals, Genentech, Merck, Novartis
4 Characteristics of Asthma Narrowing of the airways Airway obstruction Airway inflammation Increased airway responsiveness NHLBI, NAEPP, 1997.
5 Immunohistopathologic Features of Asthma Denudation of airway epithelium Collagen deposition beneath basement membrane Edema Mast cell activation Inflammatory cell infiltration Neutrophils Eosinophils Lymphocytes (TH-2 like cells) NHLBI, NAEPP, 1997.
6 Airway Remodeling Airway Wall Thickening Subepithelial Fibrosis Increased Myocyte Mass Myofibroblast Hyperplasia Mucous Metaplasia
7 Airway Remodeling: Physiologic Consequences Irreversible/Partially Reversible Airway Obstruction Airway Hyper-responsiveness responsiveness Greater Decline in FEV1 than Controls (38ml/yr vs. 22ml/yr)
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10 Regulatory T Lymphocytes CD4 +, CD25 + T lymphocytes Regulatory Express TGFβ, IL-10 Suppressive to other T cells Express Foxp3 transcription factor IL-34, IL-35 growth factors
11 Complexity of Asthma Several orders of magnitude more complex Proteome, Transcriptome, Genome Tissues, Organs, Whole Body, Brain Third and Fourth Dimensions
12 Background First Asthma Guidelines Airway inflammation was central feature of asthma - Characteristics of asthma severity described - Asthma treatment based on disease severity - Proposed outcomes to be achieved
13 Stepwise Approach for Managing Intermittent Asthma Step 1 Preferred: SABA PRN Asthma in Patients Consult with asthma specialist Aged if Step 4 care 12 or higher is requi Years Consider consultation at Step 3. Step 2 Preferred: Low-dose ICS (A) Alternative: Cromolyn (A), LTRA (A), Nedocromil (A), or Theophylline (B) Persistent Asthma: Daily Medication Consult with asthma specialist if Step 4 care or higher is required. red. Step 3 Preferred: Low-dose ICS + LABA (A) OR Medium-dose dose ICS (A) Alternative: Low-dose ICS + either LTRA (A), Theophylline (B), or Zileuton (D) Step 4 Preferred: Medium-dose dose ICS + LABA (B) Alternative: Medium-dose dose ICS + either LTRA (B), Theophylline (B), or Zileuton (D) Step 5 Preferred: High-dose ICS + LABA (B) ICS = inhaled corticosteroids; LABA = long-acting β 2 -agonist; LTRA = leukotriene receptor antagonist. Adapted from National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR ). U.S. Department of Health and Human Services. Available at: Accessed August 29, AND Consider Omalizumab for Patients Who Have Allergies (B) Step 6 Preferred: High-dose ICS + LABA + Oral Corticosteroid AND Consider Omalizumab for Patients Who Have Allergies Each Step: Patient education, environmental control, and management ent of comorbidities Steps 2-4: 2 Consider subcutaneous allergen immunotherapy for patients who have allergic asthma Quick-Relief Medication for All Patients SABA as needed for symptoms. Intensity of treatment depends on severity s of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of systemic oral corticosteroids osteroids may be needed Use of SABA >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment Step Up If Needed (first, check adherence, environmental control, and comorbid conditions) Assess Control Step Down If Possible (and asthma is well controlled at least 3 months)
14 Anti IgE Targets IgE, FCeRI Rhu Mab - E25 - Omalizumab, Xolair Reduces Free IgE (allergen specific) Reduces Eos (sputum, BAL, blood) Reduces FCeRI and FCeRII expression Efficacy - Asthma, AR
15 Major Changes in Long-Term Management Recommendations for three age groups presented separately years years - 12 years Expanded steps of therapy - 6 steps to simplify the action within each step - Medium dose ICS OR low dose ICS + LABA for patients not controlled on low dose ICS - Consider omalizumab for allergic patients not controlled on medium dose ICS + LABA
16 Definitions Severity: the intrinsic intensity of the disease process, measured clinically in untreated patients or by the least amount of medicine required to achieve control Control: the degree to which the manifestations of asthma (symptoms, functional impairment, and risk of untoward events) are minimized and the goals of therapy are met Responsiveness: the ease with which control is achieved by therapy
17 Domains of Severity and Control Impairment - Symptoms (day, night) - Reliever therapy - Activity - Lung function Risk - Exacerbation - Loss of lung function - Medication side effects
18 Steps of Therapy Preferred medications: Best balance of efficacy and safety in clinical trials for patients at that level of severity Must be tailored to individual patients needs, circumstances, and responsiveness
19 Principles of Step Therapy to Achieve Control Step up if not controlled If very poorly controlled, consider increase by 2 steps, oral corticosteroids, or both Before increasing pharmacologic therapy, consider as targets for therapy - Adverse environmental exposures - Poor adherence - Co-morbidities
20 DRAFT Asthma Guidelines Stepwise approach to therapy - 3 age groups Youths 12 years and adults Children 5 to 11 years of age Children 0 to 4 years of age
21 Key Recommendations Managing asthma in children 5-11 years Severity classification should guide initial therapy decisions. ICS are preferred initial long-term controller. Asthma control assessment should guide therapy adjustments.
22 ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN CHILDREN 5 11 YEARS OF AGE Components of Control Risk Reduction in lung growth Treatment-related adverse effects Recommended Action for Treatment (See figure 4-1bfor treatment steps.) Classification of Asthma Control (5 11 years of age) Well Controlled Maintain current step. Regular followup every 3 6 months. Consider step down if well controlled for at least 3 months. Not Well Controlled Evaluation requires long-termfollowup. Step up at least 1 step and Reevaluate in 2 6 weeks. For side effects: consider alternative treatment options. Very Poorly Controlled Medication side effects can vary in intensity fromnone to very troublesome and worrisome. The level of intensity does not correlate to specificlevels of control but should be considered in the overall assessment of risk. Consider short course of systemic oral corticosteroids, Step up 1 2 steps, and Reevaluate in 2 weeks. For side effects: consider alternative treatment options.
23 STEPWISE APPROACH FOR MANAGING ASTHMA IN CHILDREN 5 11 YEARS OF AGE Intermittent Asthma Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Step 1 Preferred: SABA PRN Step 2 Preferred: Low-dose ICS Alternative: LTRA Cromolyn, Nedocromil, or Theophylline Step 3 Preferred: Medium-dose ICS OR Low-dose ICS + either LABA, LTRA, or Theophylline Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS + either LTRA or Theophylline Step 5 Preferred: High-dose ICS + LABA Alternative: High-dose ICS + either LTRA or Theophylline AND Omalizumab may be considered for patients who have allergies Step 6 Preferred: High-dose ICS + LABA + oral corticosteroid Alternative: High-dose ICS + either LTRA or Theophylline + oral corticosteroid AND Omalizumab may be considered for patients who have allergies Step up if needed (first, check adherence and environmental control and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months)
24 Key Recommendations Managing asthma in children 0-4 years Diagnosis is often difficult. Treatment has not been adequately studied. Criteria for initiation of long-term-control therapy: 3 wheezing episodes in past year and positive asthma risk profile. those who require symptomatic treatment > 2 days per week two or more severe exacerbations within 6 months
25 ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN CHILDREN 0 4 YEARS OF AGE Components of Control Classification of Asthma Control (0 4 years of age) Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week >2 days/week Throughout the day Nighttime awakenings 1/month >1x/month >1x/week Impairment Interference with normal activity None Some limitation Extremely limited Short-acting beta 2 -agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week Several times per day
26 STEPWISE APPROACH FOR MANAGING ASTHMA IN CHILDREN 0 4 YEARS OF AGE Intermittent Asthma Persistent Asthma: Daily Medication Consult with asthma specialist if step 3 care or higher is required. Consider consultation at step 2. Step 1 Preferred: SABA PRN Step 2 Preferred: Low-dose ICS Alternative: Montelukast or Cromolyn Step 3 Preferred: Medium-dose ICS Step 4 Preferred: Medium-dose ICS AND Either: Montelukast or LABA Step 5 Preferred: High-dose ICS AND Either: Montelukast or LABA Step 6 Preferred: High-dose ICS AND Either: Montelukast or LABA AND Oral corticosteroids Step up if needed (first, check adherence and environmental control) Assess control Step down if possible (and asthma is well controlled at least 3 months)
27 ESTIMATED COMPARATIVE DAILY DOSAGES FOR INHALED CORTICOSTEROIDS IN CHILDREN Drug Beclomethasone HFA 40 or 80 mcg/puff Budesonide DPI 200 mcg/inhalation Inhalation suspension for nebulization (child dose) Flunisolide 250 mcg/puff Flunisolide-HFA 80 mcg/puff Fluticasone-HFA MDI: 44, 110, or 220 mcg/puff DPI: 50, 100, or 250 mcg/inhalation Mometasone DPI 200 mcg/inhalation Triamcinolone acetonide 75 mcg/puff Low Daily Dose Medium Daily Dose High Daily Dose Child <5 Child 5 11 Child <5 Child mg Child <5 Child mcg > mcg >320 mcg mcg > mcg >800 mcg 0.5 mg mg 1.0 mg >1.0 mg 2.0 mg mcg 1,000 1,250 mcg >1,250 mcg 160 mcg 320 mcg 640 mcg 176 mcg mcg mcg NA = not approved and no data available for children less than 12 years of age mcg 352 mcg >352 mcg mcg mcg >400 mcg NA NA NA mcg mcg >900 mcg
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29 Poor Response to Medications Social Issues Patient Related Drug Host Related
30 Poor Response to Medications Social Issues: Barriers to care (lack of insurance) Complexity of Disease/Treatment Poor Provider Patient Interactions Breakdown in Patient Education
31 Poor Response to Medications Patient Related: Non Compliance Psychological Problems (Depression) Poor Perception of Disease and Symptoms
32 Poor Response to Medications Drug/Host Biologic Related: Side Effects Lack of Benefit Cost Lack of Biomarkers Pharmocokinetics (poor absorption, frequent dosing) Pharmocogenetics
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34 PHARMACOGENETICS STUDIES IN VARIATION OF DRUG RESPONSE Population variations > individual variation Repeatability V g + V Eg r = V P
35 Pharmacogenetics Pathways of AsthmaTreatment Arachidonate Metabolism ALOX 5 LTC 4 Synthase Bronchodilation B 2 AR Immune/Inflammatory IL-4/IL-4R IL-13/IL-13R GCR
36 FCER2 Pleiotropic Effects FCER2 SNP Allele G9782a12 [T/G] G9782a19 [T/C] G9782a26 [C/T] G9782a5 [C/T] G9782a8 [C/A] Forest Haplotype Phenotype Frequency P-Value TTCCC BD % Change TCTCA BD Extremes GTCTA Steroid Extremes CAMP Haplotype Phenotype Frequency P-Value GTCTA BD % Change GTCTA BD % Change 1 yr GTCTA BD % Change 4 yr TCTTA Steroid % Ch. 1 yr TTCCC Steroid % Ch. 4 yr Global P value for Steroid % Change 1 yr = 0.001
37 FCER2 GCTTA Haplotype % with Haplotype Hospitalizations ER Visits Yes No p = (Hosp) and 0.01 (ER)
38 IMMUNOMODULATORS Closer to Pathogenesis Disease Altering and Modifying Wave of the future Cost effectiveness will progress Can be applied to Immunotherapy
39 Cytokine Modulation: Therapeutic Implications in Asthma Cytokine/Cytokine Antagonist Mechanism Receptor Antagonists: Interleukin 1 Receptor Antagonist Inhibition of cytokine-mediated Soluble Interleukin-4 Receptor signal transduction Soluble Interleukin-1 receptor Antibodies: Cytokine Inactivation Humanized Anti-IL-5-Antibodies Humanized Anti-TNF Antibodies Cytokines with Anti-allergic inflammatory activities: Interferon-γ Il-4 Antagonist Interleukin-12 TH1-like lymphocyte differentiation Interleukin-10, TGF-β Anti-inflammatory cytokines
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41 Key Central Role of IL-5 5 in Asthma
42 J ALLERGY IMMUNOL 2010 APR
43 Anti-IL IL-5 5 in Human Asthma: Reduction in Exacerbations Haldar P et al. New Engl J Med 2009;360:973 Nair P et al. New Engl J Med 2009;360:985 Severe (CCS-dependent) asthma Sputum eosinophilia required for enrollment No improvement in FEV1, control, symptoms
44 Anti-IL IL-5 5 in Human Asthma: Haldar P et al. New Engl J Med 2009;360:973 Nair P et al. New Engl J Med 2009;360:985
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47 Allergy Systems Biology Approach to Allergic Cascades Bio Therapeutics Pharmacogenetic Profiling Early Intervention
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