Topic: New Treatment = Better Outcome?

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1 Session on COPD: Novel Concepts and Promising New Drugs Topic: New Treatment = Better Outcome? Through a CME Grant sponsored by

2 New Treatment = Better Outcome? Tim S. Trinidad, MD

3 Disclosure Present: COPD Advisory Board Member & Lecturer Novartis Astra Zeneca UAP Past: COPD Lecturer Nycomed Takeda Boehringer Ingelheim Glaxo Smith Kline

4 Scope of the Discussion New Treatment = Better Outcome? Pharmacologic Non-pharmacologic Risk reduction Vaccination Rehab or Physical Activity Invasive (surgical or non-bronchoscopic LVRS)

5 Reference Point for New (2001) (2004) (2011) (2014) LABA/ ICS Tiotropium Old PDE4I New

6 Pharmacologic Agents: Recently approved in some countries or Undergoing clinical development (Not listed in GOLD 2014) TNF-a inhibitors: Infliximab, PKF , PKF IL-6 inhibitors: Tocilizumab Chemokine antagonists: ADZ8309, SCH , SB NF-kB inhibitors: IMD-0354, IMD-0650, BMS , SC-514, AS p38 MAPK inhibitors: SB681323, PH797804, PF , GSK PI3K inhibitors: PI3K-g inhibitors, TG JAK/STAT inhibitors: Tofacitinib Ngkelo, A. et al. New treatments for COPD. Current Opinion in Pharmacology 2013, 13:

7 Pharmacologic Agents: Recently approved in some countries or Undergoing clinical development (Not listed in GOLD 2014)) LABA/ICS combination: Mometasone/ Indacaterol (QMF149) LAMA/LABA/ICS triple combination inhalers : Ciclesonide/ Tiotropium/ Formoterol Beclomethasone/ Formoterol/ Glycopyrronium QMF149/Glycopyrronium Umeclidinium/ Vilanterol/ Fluticasone furoate GSK961081/ Fluticasone Ngkelo, A. et al. New treatments for COPD. Current Opinion in Pharmacology 2013, 13:

8 LABAs: LAMAs: Olodaterol, Vilanterol, Abediterol Umeclidinium LAMA/LABA combinations: MABAs: Glycopyrronium/ Indacaterol (QVA149), Umeclidinium/ Vilanterol Tiotropium/ Olodaterol Aclidinium/ Formoterol Glycopyrronium bromide/ Formoterol (PT001) GSK , AZD2115 Ngkelo, A. et al. New treatments for COPD. Current Opinion in Pharmacology 2013, 13:

9 New Pharmacologic Treatment (UPDATE 2015) (2001) (2004) (2011) (2014) (2015) LABA/ ICS Tiotropium PDE4I LABA/LAMA

10 Reference Point for Better Outcome (GOLD Treatment Goals) Reduce symptoms Relieve symptoms Improve exercise tolerance Improve health status Prevent future risks Prevent and treat exacerbations Prevent disease progression Reduce mortality GOLD Available from:

11 LABA/ ICS & Treatment Goals Relieve symptoms Improve health status Prevent and treat exacerbations Improve exercise tolerance X Reduce mortality? Prevent disease progression Calverley, P et al. Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease. N Engl J Med 2007;356: Cochrane Database of Systematic Reviews, Issue 4, 2008

12 Tiotropium & Treatment Goals Relieve symptoms Improve health status Prevent and treat exacerbations Improve exercise tolerance? Reduce mortality X Prevent disease progression Tashkin, D et al. A 4-Year Trial of Tiotropium in Chronic Obstructive Pulmonary Disease. N Engl J Med 2008;359: The Cochrane Library 2012, Issue 7

13 Unmet needs in COPD management

14 Infliximab (TNF-A Inhibitor) X CRQ X Pre-FEV1 X 6-MWT X SF-36 X TDI (?) Cancer (?) Pneumonia Rennard SI, et al. The safety and efficacy of infliximab in moderateto-severe COPD. Am J Respir Crit Care Med 2007; 175:

15 ABX vs IL-8 TDI X FEV1 X SGRQ X 6MWT Mahler DA et al. Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study. Chest 2004; 126:

16 PDE4I: Roflumilast Achieved GOLD guidelines recommendations and FDA approval in several countries Anti-inflammatory drug: used for ECOPD prevention In comparison to other (old) drugs (NNT) LAMA: 16 LABA/ ICS: 20 General COPD Roflumilast: 3-4 Cochrane Database Syst Rev Jul 11; 7:CD Nannini LJ, et al. Cochrane Database of Systematic Reviews 2012, Issue 9 Bateman, E et al. Roflumilast with long-acting β2-agonists for COPD: influence of exacerbation history. ERJ September 1, 2011 vol. 38 no

17 We continue to know more

18 Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) 3 years Follow-up Pulmonary function Whole body impedance/fat-free mass Chest computed tomography Exercise capacity Resting oxygen saturation Biomarkers Blood samples Induced sputum Exhaled breath condensate Blood and urine metabolomics Health outcomes Blood samples for genetic markers Vestbo J, et al. Am J of Resp & Crit Care Med Vol. 189 Num. 9 May

19 COPD is very heterogeneous clinical presentation Some patients are frequent exacerbator others are not Some patients have severe inflammation others have less inflammation Some patients are rapid FEV1 decliners others are not For those rapid decliners, the greatest decline occurs in the moderate to severe stage Vestbo J, et al. Am J of Resp & Crit Care Med Vol. 189 Num. 9 May

20 COPD phenotype A single or combination of disease attributes that describe differences between individuals with COPD as they relate to clinically meaningful outcomes : Symptoms Exacerbations Response to therapy Rate of disease progression Death

21 COPD Phenotype Application Roflumilast Story

22 Design OPUS ( 111) / RATIO (112) Study N: 2,686 FEV1: <50% Meds: SABA & SAMA ICS 52 Weeks Roflumilast: 500 Placebo

23 Rate Ratio of Exacerbation (moderate & severe) Study Favors Roflumilast Favors Placebo iexacerb. Rate (%) M M Why? Rate Ratio

24 Post-hoc Analysis: Who are the responders?

25 Identification of Patient Target Population Subgroup analyses of early phase III studies M2-111, M2-112 Confirmatory 1-yr pivotal studies M2-124, M2-125 Severe/very severe COPD Severe/very severe COPD Hx chronic cough & sputum Hx chronic cough & sputum Hx of exacerbations

26 Pivotal Study M2-124/ M2-125 N: 3,091 FEV1: <50% IC: (+) C. Bronchitis (+) Sputum (+) Exacerbations Meds: No ICS (+) LABA (+) SAMA 52 Weeks Roflumilast: 500 Placebo Calverley PMA, Rabe, KF et al. Lancet 2009;374:

27 Rate Ratio of Exacerbation (moderate & severe) Study Favors Roflumilast Favors Placebo iexacerb. Rate (%) M M M M Rate Ratio Calverley PMA, Rabe, KF et al. Lancet 2009;374:

28 GOLD: Statements on Roflumilast The phosphodiesterase 4 inhibitor (Roflumilast) may also be used to reduce exacerbations for patients with chronic bronchitis, severe and very severe airflow limitation, and frequent exacerbations that are not adequately controlled by long- acting bronchodilators. GOLD Available from:

29 FEV 1 (% of value at age 25) Decline in Lung Function of COPD Patients Fletcher-Peto Curve vs ECLIPSE Curve Most Rapid Decline (ECLIPSE) Most Rapid Decline (Fletcher) Never smoked or not susceptible to smoke Smoked regularly and susceptible to its effects Age (years) Vestbo J, et al. Am J of Resp & Crit Care Med Vol. 189 Num. 9 May

30 Do we have a better response if we give the drugs during the early stage? Tiotropium UPLIFT Story

31 UPLIFT Study N: 4,383 FEV1: <70% Meds allowed: SABA, LABA ICS, Xanthine 4 Years Tiotropium 18 ug OD Placebo Yearly decline in Pre FEV1 Post FEV1

32 Tashkin, D et al. A 4-Year Trial of Tiotropium in COPD. N Engl J Med 2008;359: Decramer, M. et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet 2009; 374: UPLIFT Decline in FEV1 N: All Subjects N: Subjects with moderate Obstruction Tiotropium : 40±1 ml per year Placebo: 42±1 ml per year P = 0.21 Tiotropium : 43±2 ml per year Placebo: 49±2 ml per year P = 0.024

33 Clinical Trials in COPD FEV1 Inclusion Criteria Study FEV1 % predicted inclusion criteria TORCH ( ) < 60% UPLIFT ( ) < 70% Glycopyronium/ Indacaterol < 80% and 30% Umeclidinium/ Vilanterol 70% Glycopyrrolate/ Formoterol < 80% and 30% Tiotropium/ Olodaterol < 80%

34 LAMA/ LABA FDC for COPD: Approved or Under Investigation Banerji, D. et al. Dual bronchodilation for the treatment of chronic obstructive pulmonary disease: a review of the latest clinical data. Clin. Invest. (2014) 4(6),

35 Banerji, D. et al. Dual bronchodilation for the treatment of chronic obstructive pulmonary disease: a review of the latest clinical data. Clin. Invest. (2014) 4(6),

36 Banerji, D. et al. Dual bronchodilation for the treatment of chronic obstructive pulmonary disease: a review of the latest clinical data. Clin. Invest. (2014) 4(6),

37 Banerji, D. et al. Dual bronchodilation for the treatment of chronic obstructive pulmonary disease: a review of the latest clinical data. Clin. Invest. (2014) 4(6),

38 Banerji, D. et al. Dual bronchodilation for the treatment of chronic obstructive pulmonary disease: a review of the latest clinical data. Clin. Invest. (2014) 4(6),

39 New Treatment = Better Outcome? Yes, but there is room for improvement.

40 Medicines in Development COPD: 2012 Report America s biopharmaceutical research companies

41 Medicines in Development COPD: 2012 Report America s biopharmaceutical research companies

42 New Treatment = Better Outcome? (part 2) PCCP Mid-year 2018 Version

43 New Treatment = Better Outcome? We know more about COPD. Beginning to know: Who and when to give the drug. Yes, new treatment = better outcome but we need more. More drugs in development.

44 RCT New Treatment Better Outcome Real World Morbidity Mortality Health providers General population Patient Diagnose early COPD Spirometry facility Increase awareness How to recognize How to treat Why & how to use inhalers

45 Thank you very much for your attention

46 Session on COPD: Novel Concepts and Promising New Drugs Topic: New Treatment = Better Outcome? Through a CME Grant sponsored by

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