Goals and Learning Objectives
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1 Small Airways (SAW) Symposium: Asthma Treatment Issues. New Bronchodilator for Asthma: A Patient Centric Approach for Treating Asthma Stephen P. Peters, MD, PhD, FAAAAI, FACP, FCCP, FCPP Thomas H. Davis Chair in Pulmonary Medicine Chief, Section on Pulmonary Critical Care, Allergy & Immunologic Diseases Wake Forest School of Medicine Stephen P. Peters, MD, PhD Disclosure Basic and Clinical Research NHLBI (AsthmaNet, SARP, SPIROMICS) ALA (ACRC) Book Chapters UpToDate Merck Manuals Pharmaceutical Trials Actelion, Amgen, Astra Zeneca, Boehringer Ingelheim, Centocor, Cephalon, Genentech, GlaxoSmithKline, Forest, Medimmune, Sanofi aventis Advisory Boards Array Biopharma, AstraZeneca, Aerocrine, Airsonett AB, Boehringer Ingelheim, Experts in Asthma, Gilead, GlaxoSmithKline, Merck, Novartis, Ono Pharmaceuticals, Pfizer, PPD Development, Quintiles, Sunovion, Saatchi & Saatichi, Targacept, TEVA, Theron Speakers Bureaus Integrity CE Editorial Boards Resp Med, Assoc Editor, Resp Research, Assoc Ed J Allergy Case Reports in Medicine US Resp Disease J Pulm Resp Medicine Clin Exp Med Sciences JACI: In Practice Goals and Learning Objectives Discuss the use of Patient Characteristics to Guide Asthma Treatment with respect to Characteristics of Inflammation Smoking Hyperinflation Airflow Limitation N of 1 Approaches as an Adjunct 1
2 From Clinical to Molecular to Endotype Ray A, et al. Am J Physiol Lung Cell Mol Physiol Oct ACOS Revised Taxonomy Bateman, et al. Lance Resp Med 2015; 3: Relative Proportions Over Lifetime Disease Expression Late Onset Asthma Asthma All Asthma Phenos Bronchiolitis Neonatal Resp Distress Poor Development COPD ACOS Drugs for COPD and Asthma LABAS Salmterol (GSK) Formoterol (MSD) Arformoterol (Sunovion) Indacaterol (Novartis) Arcapta Olodaterol (BI) Striverdi LAMAs Tiotropium (BI) Aclidinium (Actavis) Tudorza Umeclidinium (GSK) Incruse LAMA/LABAs Umeclidinium/Vilanterol (GSK) Anoro Tiotropium/Olodaterol (BI) Stiolto ICS/LABAs Fluticasone pro/salmterol (GSK) Budesonide/Formoterol (AZ) Mometasone/Formoterol (MSD) Fluticasone fur/vilanterol (GSK) Breo PDE Inhibitors Theophyline Roflumilast Leukotriene Modifiers Montelukast Antibiotics Azithromycin Biologics 2
3 Patient Characteristics to Guide Therapy Characteristics of Inflammation Smoking Without or With COPD Air Trapping Airflow Limitation With Reversibility Persistent Obstruction Characteristics of Inflammation Barnes. J Allergy Clin Immunol 2015; 136: Targeting Sputum Eosinophils in Asthma Inhaled Corticosteroids Mepolizumab Anti-IL-5 Green RH, et al. Lancet 2002;360: Nair P, et al. NEJM. 2009;360:
4 Characteristics of Inflammation Barnes. J Allergy Clin Immunol 2015; 136: ACOS Revised Taxonomy Bateman, et al. Lance Resp Med 2015; 3: Patient Characteristics to Guide Therapy Characteristics of Inflammation Smoking Without or With COPD Air Trapping Airflow Limitation With Reversibility Persistent Obstruction 4
5 Effect of Smoking on Response to ICS and LTRA in Asthma Non Smokers Smokers FEV1 (L) PEF (L/M) Beclo Montelukast Beclo Montelukast Lazarus, et al. AJRCCM 2007; 175: Tiotropium: COPD and Concomitant Asthma Magnussen, et al. Resp Med 2008; 102:50 56 Baseline FEV1 After Wk 12 FEV1 Patient Characteristics to Guide Therapy Characteristics of Inflammation Smoking Without or With COPD Air Trapping Airflow Limitation With Reversibility Persistent Obstruction 5
6 Effect of Small Particle ICS on Exhaled Nitric Oxide (eno) Placebo Ciclesonide # P=0.006 from Mann Whitney U test P=0.012 from Wilcoxon signed rank test. Cohen Cohen J, et J, et al. al. Eur EurRespirJ. 2008;31: Patient Characteristics to Guide Therapy Characteristics of Inflammation Smoking Without or With COPD Air Trapping Airflow Limitation With Reversibility Persistent Obstruction Morning PEF, L/min NHLBI ACRN s Tiotropium Add on Therapy to ICS (TALC) Trial: Study Outcomes Morning PEF Trough FEV 1 Asthma control days p = 0.26 p < p < Pre bronchodilator FEV 1, L p = p = p = 0.89 Asthma control days (no./14 days) p = 0.01 p = 0.78 p = d/yr 19 d/yr 51 d/yr 10 Tio/ 2 beclo Sal/ 0.05 Tio/ 2 beclo Sal/ 1 Tio/ 2 beclo Sal/ Peters, et al. N Engl J Med. 2010;363:
7 Predictors of Response to Tiotropium: Summary Higher Cholinergic Tone (Lower Resting Heart Rate) Greater Airway Obstruction (Lower FEV1/FVC ratio) Positive Response to Short Acting Bronchodilator (Albuterol > Ipratropium) Younger Age (Asthma Control Days) Peters, et al., J Allergy Clin Immunol 2013; 132: Exploratory Predictors Not Associated with Response to Tiotropium Ethnicity Gender Atopy (skin test +) IgE Level (ln) Sputum Eosinophils FENO (ln) Asthma Duration BMI Peters, et al., J Allergy Clin Immunol 2013; 132: Combination Tiotropium & Olodaterol Therapy in COPD Mean AUC 0 3 hr FEV1 Trough FEV1 Responses Ferguson, et al. Adv Ther 2015; 32:
8 Response of Persistent, Intermittent, and Non Eosinophilic Asthmatics to Antiinflammatory Tx and Agonists Antiinflammatory Tx Non Eos All Respond to Ags Persistent Eos McGrath, et al. AJRCCM 2012;185: Lung Elastic Recoil in Asthma Never Smokers ( yrs, Persistent Airflow Obstruction) Gelb et al. 2015; 148: Centrilobular Emphysema in Elderly Never Smoker Asthmatics 72 yr F FEV1/FVC 49% FEV1 1.3 L (60%) 82 yr F FEV1/FVC 48% FEV1 1.7 L (81%) Normal Control Gelb et al. 2015; 148:
9 Time for one person trials Precision medicine requires a different type of clinical trial that focuses on individual, not average, responses to therapy, says Nicholas J. Schork. Nature 2015; 250: Nature 2015; 250: Differential Response to Tiotropium vs Salmeterol: PEF am Better response to tiotropium (N = 78) Participants Better response to salmeterol (N = 90) Difference in AM Peak Flow Response, % of Baseline (Tiotropium Salmeterol) Peters, et al. JACI 2013:132:1068 9
10 Differential Response to Tiotropium vs Salmeterol: Asthma Control Days Better response to tiotropium (N = 53) Participants Better response to salmeterol (N = 49) Difference in asthma control days response (Tiotropium Salmeterol) Peters, et al. JACI 2013:132:1068 The N of 1 Clinical Trial: The Ultimate Strategy for Individualizing Medicine? Do n of 1 trials have a role in clinical science? o N of 1 trials that focus exclusively on the objective, empirically determined optimal intervention for a single patient are compatible with the ultimate end point of clinical practice: the care of individual patients. o Meta analyses of the outcomes of multiple n of 1 trials could be compared with standard treatment regimens and help put into context the utility and practicality of n of 1 trials. Design issues in n of 1 clinical trials o Randomization of treatment order, carryover effects, washout periods and blinding are key design elements that need to be considered in n of 1 trials. The analysis of n of 1 clinical trials o Methods that account for serial correlation in comparing the response to two or more treatments, such as certain time series analyses, are necessary. o More research into how to identify and accommodate carryover effects in n of 1 trials is clearly needed. Per Med 2011; 8: How Should Control of Asthma Be Assessed? Exacerbations Utilization of Healthcare Resources Inflammation: Direct or Indirect? Lung Function Missed Work and/or School Functional Status Asthma Control Daytime Symptoms Patient Self Report of Control Nighttime Awakenings Use of a Quick Relief Inhaler and/or Nebulizer Adapted from Chipps BE, Spahn JD. J Asthma. 2006;43:
11 Adding N of 1 Trials to Genomics J Clin Invest 2014:; 123: Two Step Model for Asthma Initiation and Progression AND Eos Role in Exacerbation Li X, et al. JACI 2013;132: Exacerbations! Questions? 11
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