Progress in Treating Disease: The Case of Asthma

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1 13TH EUROPEAN HEALTH FORUM CHRONIC RESPIRATORY DISEASES: A NEGLECTED EPIDEMICS GASTEIN 7 OCTOBER 2010 Progress in Treating Disease: The Case of Asthma Leonardo M. Fabbri Clinica di Malattie dell Apparato Respiratorio Università degli Studi di Modena e Reggio Emilia Azienda Ospedaliero-Universitaria - Policlinico di Modena

2 PROGRESS IN TREATING DISEASE: THE CASE OF ASTHMA Development of guidelines Inhaled steroids and anti-leukotriens Combination therapy Monoclonal Antibodies (Anti-IgE, anti IL-5) Thermoplasty UNMET NEEDS -Education/adherence -Asthma phenothypes and targeted therapy GINA Asthma Guidelines, Eur Respir J Jan;31(1): ATS/ERS Asthma Severity & Control, Am J Respir Crit Care Med Jul 1;180(1):59-99

3 PATHOLOGY OF ASTHMA

4 Management of asthma: updating the GINA guidelines, 2010 Asthma severity Clinical Features Before Treatment Mild Intermittent Mild Persistent Moderate Persistent Moderate Persistent (Severe?) Severe Persistent (Very severe?) Avoidance of risk factors, immunotherapy Fast-acting acting beta-2 agonists as needed Low-dose inhaled steroids Combination of long-acting beta2 agonists with low dose inhaled steroids Combination with higher doses inhaled corticosteroids, theophylline, antileukotrienes Systemic steroids Anti-IgE GINA Asthma Guidelines, Eur Respir J Jan;31(1):

5 The Goal of Asthma Management is: Overall Asthma Control achieving Current Control reducing Future Risk defined by defined by Symptoms Reliever use Instability/ worsening Exacerbations Activity Lung function Lung function loss Medication adverse effects ATS/ERS Asthma Severity & Control, Am J Respir Crit Care Med Jul 1;180(1):59-99

6 PHARMACOLOGIC TREATMENT OF ASTHMA 2010

7 Effects of Inhaled Beclomethasone Dipropionate in Clinical Asthma Severity Pre-BD Bronchial Function Asthmatic symptoms 6 wk mg/ml ,1 0,01 PC20 methacholine (mg/ml) Pre-BD 6 wk number of cells/mm 2 of submucosa mast cells Bronchial Submucosa eosinophils T lymphocytes Pre-BD 6 wk Pre-BD 6 wk Pre-BD 6 wk Djukanovic et al, Am Rev Respir Dis 1992 Mar;145(3):669-74

8 WELL CONTROLLED ASTHMA Patients (%) 80 70% 78% FP Phase II FP Phase I 75% Sal/FP Phase II Sal/FP Phase I 60 60% 62% 47% Steroid-naive (S1) Low-dose ICS (S2) Moderate-dose ICS (S3) Bateman E, et al. Am J Respir Crit Care Med 2004;170:

9 Complementary effects of LABA/ICS combination therapy LABA Smooth muscle dysfunction Airway inflammation/ remodelling ICS Bronchoconstriction Bronchial hyperreactivity Hyperplasia Inflammatory mediator release Inflammatory cell infiltration/activation Mucosal oedema Cellular proliferation Epithelial damage Basement membrane thickening Symptoms/exacerbations ICS, inhaled corticosteroid LABA, long-acting β 2 -agonist Johnson. Curr Allergy Clin Immunol 2002

10 Fluticasone propionate induces translocation of glucocorticoid receptor into the cell nucleus min Glucocorticoid receptor stained red GlaxoSmithKline. Data on file

11 SMILE Study: Severe Exacerbations Total No. events p<0.001 Hospitalisations/ ER treatment p< p<0.001 p< Maintenance Form/Bude + prn Terbutal Formoterol Form/Bude Rabe KF et al, Lancet Aug 26;368(9537):744-53

12 Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE Clinically significant Asthma exacer bations rate P= omalizumab placebo 0.6 P= Severe asthma exacer bations rate omalizumab placebo Humbert M et al; Allergy 2005; 60:

13 Severe Exacerbations during the Course of the Study Cumulative No. of exacerbations Placebo Mepolizumab Start of treatment No. of subjects Placebo Mepolizumab Month No. of exacerbations Haldar P. et al., N Engl J Med 2009; 360:

14

15 PROGRESS IN TREATING DISEASE: THE CASE OF ASTHMA Development of guidelines Inhaled steroids and anti-leukotriens Combination therapy Monoclonal Antibodies (Anti-IgE, anti IL-5) Thermoplasty UNMET NEEDS -Education/adherence -Asthma phenothypes and targeted therapy GINA Asthma Guidelines, Eur Respir J Jan;31(1): ATS/ERS Asthma Severity & Control, Am J Respir Crit Care Med Jul 1;180(1):59-99

16 13TH EUROPEAN HEALTH FORUM CHRONIC RESPIRATORY DISEASES: A NEGLECTED EPIDEMICS GASTEIN 7 OCTOBER 2010 Progress in Treating Disease: The Case of Asthma Leonardo M. Fabbri Clinica di Malattie dell Apparato Respiratorio Università degli Studi di Modena e Reggio Emilia Azienda Ospedaliero-Universitaria - Policlinico di Modena

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