Treatment Responses. Ronald Dahl, Aarhus University Hospital, Denmark

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1 Asthma and COPD: Are They a Spectrum Treatment Responses Ronald Dahl, Aarhus University Hospital, Denmark

2 Pharmacological Treatments Bronchodilators Inhaled short-acting β -Agonist (rescue) Inhaled short-acting anticholinergic Inhaled long-acting β -agonist Inhaled long-acting anticholinergic 2 2 Controllers Oral steroid Inhaled corticosteroids Low dose theophylline Anti-leukotriene Anti-IgE Mild mod asthma Severe asthma COPD Mild mod asthma Severe asthma COPD + (+) + + +

3 Asthma COPD Allergen avoidance Smoking cessation

4 First line treatment Asthma Inhaled corticosteroid COPD Inhaled long acting bronchodilators i.e. LAMA and LABA

5 First line treatment Asthma Inhaled corticosteroid COPD Inhaled long acting bronchodilators i.e. LAMA and LABA Second line treatment LABA LAMA antileukotrienes Inhaled corticosteroid PDE4 inhibitor

6 First line treatment Asthma Allergen avoidance Inhaled corticosteroid COPD Smoking cessation Inhaled long acting bronchodilators i.e. LAMA and LABA Second line treatment LABA LAMA antileukotrienes Anti IgE Allergen immunotherapy Inhaled corticosteroid PDE4 inhibitor antibiotics

7 The central role of inflammation and bronchial hyperresponsiveness leading to symptoms in asthma Allergens, Exercise, Irritants, endogenous Exacerbations Infections, allergens Eosinophilic inflammation Bronchial hyperresponsiveness Expiratory flow limitation Hyperinflation Bronchial obstruction Spasm, plugs Breathlessness Symptoms Disability Quality of life Disease progression asthma Inactivity Death Adapted from Cooper. Respir Med 2009

8 The central role of inflammation and bronchial hyperresponsiveness leading to symptoms in asthma x Allergens, Exercise, Irritants, endogenous Exacerbations Infections, allergens Eosinophilic inflammation Bronchial hyperresponsiveness Expiratory flow limitation Hyperinflation Bronchial obstruction Spasm, plugs Breathlessness Symptoms Disability Quality of life Disease progression asthma Inactivity Death Adapted from Cooper. Respir Med 2009

9 The central role of inflammation and bronchial hyperresponsiveness leading to symptoms in asthma x xxxx Allergens, Exercise, Irritants, endogenous Exacerbations Infections, allergens Eosinophilic inflammation Bronchial hyperresponsiveness Expiratory flow limitation Hyperinflation Bronchial obstruction Spasm, plugs Breathlessness Symptoms Disability Quality of life Disease progression asthma Inactivity Death Adapted from Cooper. Respir Med 2009

10 Levels of Asthma Control (Assess patient impairment) Assessment of Future Risk (risk of exacerbations, instability, rapid decline in lung function, side effects) Gina 2010

11 TO STEP 3 TREATMENT, SELECT ONE OR MORE: TO STEP 4 TREATMENT, ADD EITHER tiotropium Shaded green - preferred controller options Gina 2010

12 Clinical effects of inhaled corticosteorids in bronchial asthma Certain improve reduce Probable Possible reduce quality of life, physical, social and psychical function lung function BHR = diurnal variation, EIA etc. symptoms day/night exacerbation/hospitalizations need for rescue medication need for oral corticosteroids asthma deaths acc. decline in lung function long term remission/cure

13 Time to TOTAL CONTROL for individual criteria in the GOAL study for Seretide treated patients Proportion of patients achieving control 1.0 No night awakenings No rescue SABA use PEF am No daytime symptoms Phase I Phase II Time to first week of T OTAL CONTROL (All strata) GOAL Study

14 Continued improvements with sustained treatment well controlled asthma Seretide FP 100 % of patients controlled each week Week All patients GOAL Study 52

15 Mild to moderate asthma treatment for 8 weeks with FP Chervinsky et al. JACI 1994, 94:

16 Relative increase in the number of asthmatic patients entitled to special reimbursement for their drug costs and decreases in death rate and days in hospital (index, 1981=100)

17 Ratio of the use of inhaled corticosteroids and short acting beta-2agonists from 1994 to 1999

18 Change in mean PEF after inhaled beclomethasone (BDP) in asthma Chan ge in mean PEF from baseline (L/m) 25 Non-smoker 400 mcg BDP * * 2 weeks * 6 weeks Time (weeks) * p<0.01 Smoker 400 mcg BDP 12 weeks Tomlinson et al, Thorax 2005

19 Change in mean PEF after inhaled beclomethasone (BDP) in asthma Chan ge in mean PEF from baseline (L/m) 25 Non-smoker 400 mcg BDP 20 Non-smoker 2000 mcg BDP Smoker 2000 mcg BDP 5 0 * * 2 weeks * 6 weeks Time (weeks) * p<0.01 Smoker 400 mcg BDP 12 weeks Tomlinson et al, Thorax 2005

20 Arguments for ICS in COPD Pro CON Reduced rate of exacerbations Reduced decline in quality of life Reduced annual decline in spirometry Local side effect in mouth and throught Horseness Pneumonia Suppression HPA axis Cost Cochrane Database of Systematic Reviews 2007

21 Exacerb/patient/Year Background - ICS on exacerbation rate 2 1,8 1,6 1,4 1,2 1 0,8 0,6 0,4 0,2 0 PLC FP p<0.022 p=0.026 p=0.45 Total FEV1<50% FEV1>50% Eur Respir J 2003; 21: 68

22 Asthma-related mortality and ICS sales in New Zealand: Mortality ICS Year Suissa S, Ernst P. J Clin Epidemiol 1997;50: Millions of doses: hundreds Mortality per 100,000 people 5

23 Rate ratio of asthma-related deaths by number of ICS MDIs per year Rate ratio of asthma-related deaths Number of ICS MDIs per year Adapted from Suissa S, et al. N Engl J Med 2000;334:

24 Addition of inhaled long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults ICS + LABA better than ICS alone Asthma exacerbations FEV-1 No Yes ml Symptom free days Yes 11 % (CI 2 20) Rescue beta-2 use No Adverse events, withdrawals incl withdrawals due to poor asthma control No insufficient evidence to recommend use of combination therapy rather than ICS alone as a first-line treatment Chroin 2009 The Cochrane Collaboration

25 Study design Lundback et al. Respir Med 2006

26 Treatment flow Lundbäck et al. Respir med 2006

27 Time to first increase from randomised treatment % patients without change in randomised treatment FP/salmetrol 50/250mcg bd Fluticasone 250mcg bd 100 Salmeterol 50mcg bd Time to first increase from randomised treatment (years) Lundbäck et al. Respir med 2006

28 Changes in treatment and dose throughout the study period Lundback B et al, Respir Med 2006

29 tiotropium

30 The central role of airflow limitation leading to symptoms in COPD COPD Exercise Expiratory flow limitation Air trapping Hyperinflation Exacerbations Breathlessness Deconditioning Quality of life Inactivity Reduced exercise capacity Disability Disease progression Death Adapted from Cooper. Respir Med 2009

31 The central role of airflow limitation leading to symptoms in COPD COPD Exercise Expiratory flow limitation Air trapping Hyperinflation Inhibition of these events reduce attacks and improve symptoms Exacerbations Breathlessness Deconditioning Quality of life Inactivity Reduced exercise capacity Disability Disease progression Death Adapted from Cooper. Respir Med 2009

32 Outcomes are correlated with mean change from baseline in trough FEV1 Category centred value of FEV1 Average FEV1 (ml) (ml) 500, TDI (n=2,781) 1.44 SGRQ (n=3,141) 3.15 Exacerbation rate/year (n=3,158) , , , , TDI and SGRQ at 12 weeks improved with increasing positive FEV1 (all p<0.001) Individual-level correlations: r= Cohort-level correlations: r= Jones et al. BTS 2010

33 As new bronchodilators are introduced there have been more consistent improvements in outcomes for patients with COPD Improvement in outcome Duration of action (hours)1 Lung function2 Albuterol 4 6 NA NA Ipratropium bromide 6 8 Salmeterol 12 ( ) Formoterol 12 Tiotropium 24 ( ) ( ) 8 Breathlessness 2 8 Exercise endurance*1,2 Quality of life1 14 Exacerbations 1 3,5,7 14 evidence of effectiveness; evidence of effectiveness over SABA or SAMA; evidence of effectiveness over LABA *Outcome demonstrated by all bronchodilators, lack of evidence of significant differences between them Equivocal evidence depending on formulation;5,10,11 Evidence of numerical improvements over shorter acting comparator4,8 NA = evidence not available 1. GOLD 2009; 2. Celli et al. ERJ 2004; 3. Mahler et al. Chest 1999; 4. Rennard et al. AJRCCM Dahl et al. AJRCCM 2001; 6. Wadbo et al. ERJ 2002; 7. Vincken et al. ERJ 2002; 8. Brusasco et al. Thorax Rutten van-molken et al. Eur J Health Econ 2007; 10. Szafranski et al. ERJ 2003; 11. Calverley et al. ERJ Calverley et al. NEJM 2007; 13. Niewoehner et al. Ann Intern Med 2005; 14. Tashkin et al. NEJM 2008

34 Bronchodilators remain central to the symptomatic management of COPD Compared with placebo, existing long-acting bronchodilators1: significantly improve and sustain lung function significantly improve hyperinflation and symptoms of breathlessness significantly improve quality of life Significantly reduce exacerbations 1. GOLD 2009

35 18 TORCH Study, COPD all cause mortality 16.0% % 13.5% 12.6% Probability of death (%) % p= Placebo Salm 96 FP Time to death (weeks) Calverley PA et al: NEJM 2007 FP/Salm

36 TORCH Study: 2x2 Factorial analysis Yes (deaths) No (deaths) Crude RR Adjusted RR Fluticasone 439/ / Salmeterol 398/ / (p=0.0043) No interaction between FP and salmeterol: p=0.32 All of the benefit provided by salmeterol Suissa S et al: ERJ 2008

37 Annual decline in postbronchodilator FEV1 ml/year in the UPLIFT and TORCH studies UPLIFT Placebo TORCH TIO Placebo 55 S F 42 SFC P<0.003 NS P<0.001

38 Probability of death (%) after 3 years observation in two large COPD trials UPLIFT Probability of death % 16 TORCH P= Control 11.0 TIO 10.1 P=0.09 Placebo SFC

39 Exacerbation rates in two large COPD trials UPLIFT Exacerbations / year / patient 1.2 TORCH Placebo -25% 0.9 Control % TIO 0.73 SFC

40 Mean rate of exacerbations per patient per year 1 year studies - different maintenance treatments 1,5 M2-124 M % % (CI -26;-2) p = (CI -29;-7) p = , Placebo 500µg Roflumilast Calverley PM et al. Lancet 2009

41 6 months studies Maintenance treatment with salmeterol 1 0,95 0,9 Hazard ratio = 0.6 xcg e ailtyfn b ro p vl) (su tio xcrb e an 0,85 (CI0.4;0.9) p = , Placebo days 500µg Roflumilast Fabbri LM et al. NEJM 2009

42 6 months studies Maintenance treatment with tiotropium 1 0,95 0,9 Hazard ratio = 0.8 (CI 0.5;1.1) p = probailtyfnexcg anexcrbtio(suvl) 0,85 0, Placebo days 500µg Roflumilast Fabbri LM et al. NEJM 2009

43 Roflumilast adverse effects GI symptoms Weight loss

44 Combined assessment of COPD Assess symptoms Assess degree of airflow limitation using spirometry Assess risk of exacerbations An opportunity to combine these assessments for the purpose of improving management of COPD APSR 2011 GOLD 2011 Revision J Vestbo

45 (C) (D) 2 or more (A) (B) 1 Risk mmrc 0-1 CAT < 10 APSR 2011 (Exacerbation history) 4 Risk (GOLD Classification of Airflow Limitation) Combined assessment of COPD mmrc 2+ CAT 10+ Symptoms (mmrc or CAT score)

46 Combined assessment of COPD Patient Characteristic Spirometric Exacerbations Classification per year mmrc CAT A Low Risk, Less Symptoms GOLD < 10 B Low Risk, More Symptoms GOLD C High Risk, Less Symptoms GOLD < 10 D High Risk, More Symptoms GOLD

47 Management of COPD the aims Relieve symptoms Improve exercise tolerance Improve health status Prevent disease progression Prevent and treat exacerbations Reduce mortality APSR 2011 GOLD 2011 Revision

48 Management of COPD the aims Relieve symptoms Improve exercise tolerance Improve health status Reduce symptoms Prevent disease progression Prevent and treat exacerbations Reduce mortality Reduce risk APSR 2011 GOLD 2011 Revision

49 Management of COPD Pharmacological First choice GOLD 4 2 or more GOLD 3 Exacerbations per year GOLD 2 1 GOLD 1 0 mmrc 0-1 CAT < 10 mmrc 2+ CAT 10+

50 Management of COPD Pharmacological First choice GOLD 4 2 or more GOLD 3 Exacerbations per year GOLD 2 1 SABA or SAMA prn. GOLD 1 0 mmrc 0-1 CAT < 10 mmrc 2+ CAT 10+

51 Management of COPD Pharmacological First choice GOLD 4 2 or more GOLD 3 Exacerbations per year GOLD 2 SABA or SAMA prn. LABA or LAMA GOLD mmrc 0-1 CAT < 10 mmrc 2+ CAT 10+

52 Management of COPD Pharmacological First choice GOLD 4 GOLD 3 LABA and ICS or LAMA 2 or more Exacerbations per year GOLD 2 SABA or SAMA prn. LABA or LAMA GOLD mmrc 0-1 CAT < 10 mmrc 2+ CAT 10+

53 Management of COPD Pharmacological First choice GOLD 4 GOLD 3 LABA and ICS or LAMA LABA and ICS and LAMA 2 or more Exacerbations per year GOLD 2 SABA or SAMA prn. LABA or LAMA GOLD mmrc 0-1 CAT < 10 mmrc 2+ CAT 10+

54 Management of COPD Pharmacological Patient First choice First alternatives Other alternatives A SABA or SAMA prn. SABA and SAMA LABA or LAMA Theophylline LABA and LAMA Theophylline SABA or SAMA SABA and SAMA LABA and ICS or LAMA LABA and LAMA Theophylline SABA and/or SAMA Consider PDE4-inh. LAMA and ICS LABA and ICS and LAMA ICS/LABA and LAMA ICS/LABA and PDE4-inh. LAMA and PDE4-inh. Theophylline SABA and/or SAMA LAMA and ICS Carbocysteine B C D LABA or LAMA

55 First line treatment Asthma Allergen avoidance Inhaled corticosteroid COPD Smoking cessation Inhaled long acting bronchodilators i.e. LAMA and LABA Second line treatment LABA LAMA antileukotrienes Anti IgE Allergen immunotherapy Inhaled corticosteroid PDE4 inhibitor antibiotics

56 Thank you for your attention

รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น

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