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ACO wg summit 2018

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WG minutes from REG Summit 2018

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ACO wg summit 2018

  1. 1. Asthma-COPD Overlap (ACO) Working Group Meeting CHAIR: Jerry Krishnan/ Nicolas Roche/ David Price DATE: Thursday 22nd March 2018 TIME: 14.00–15.00 VENUE: Park Plaza Hotel, Amsterdam Airport
  2. 2. Agenda 1) Update on current project ‘ACOS proof of concept study- Comparability of different population-definitions of ACOS within a UK database’. 2) Discussion on progressing forward with future studies a) ‘Implications of a mixed asthma-COPD phenotype vs COPD alone on patient outcomes’ using the OPCRD patients in the proof of concept study b) Evaluation of the ACO definitions in other national databases. 3) Any new project ideas?
  3. 3. 1) Update on current project ACOS proof of concept study
  4. 4. Background / rationale • 2014, GINA and GOLD published their first joint statement on Asthma-COPD Overlap Syndrome (ACOS)1 • Current thinking now recommends reference to ACO rather than ACOS based on the clinical implications of the term “syndrome”2 • Various criteria for diagnosis of ACO have been proposed2-4 • The lack of a gold standard definition is a barrier to ACO research and to understanding the biology of the condition and optimum management approaches5 1. GINA-GOLD Diagnosis of disease of chronic airflow limitation: Asthma, COPD and asthma-COPD overlap syndrome (ACOS), 2014; 2. Barnes PJ. Asthma-COPD Overlap. Chest. 2016;149:7-8; 3. Miravitlles M, et al. Arch Bronconeumol 2014; 4.Koblizek V, et al. Pap Med Fac Univ Palacky Olomouc Czech Repub 2013; 5. Kankaanranta H, et al. Basic Clin Pharmacol Toxicol. 2015;6. Postma DS, Rabe KF. NEJM 2015
  5. 5. Proof of Concept Study Aim: Explore the influence of the definition on the prevalence and clinical presentation of ACO in databases used for observational research, in order to inform (a) standard definition(s) for future studies and clinical trials. Study design: • Historical cohort study using the UK’s Optimum Patient Care Research Database which contains >2.9 million patients from >576 primary care practices across the UK • Patients with 2 years of continuous records within the observation period 1 January 2014-31 December 2015
  6. 6. Population Definition Summary Clinical diagnosis of COPD N=1,017 Aged ≥40 years N=1,015 Evidence of smoking N=940 Airflow Obstruction (Post BD FEV1 per cent predicted or FEV1/FVC <0.7) N=750 Airflow Reversibility (≥12% and ≥200mL increase in post- bronchodilator FEV1) N=208 Subgroup A3 n= 2 (Patient is <40 years) n= 75 (No evidence of smoking – current or ex) n=190 (No airflow obstruction) n= 542 (No airflow reversibility) Subgroup A2 Subgroup A1 Subgroup A POPULATION A Clinical diagnosis of Asthma & COPD N=398 Aged ≥40 years N=395 Evidence of smoking N=330 Airflow Obstruction (Post BD FEV1 per cent predicted or FEV1/FVC <0.7) N=244 Airflow Reversibility (≥12% and ≥200mL increase in post- bronchodilator FEV1) N=127 Subgroup B3 Subgroup B2 Subgroup B1 Subgroup B POPULATION B n= 3 (Patient is <40 years) n= 65 (No evidence of smoking – current or ex) n= 86 (No airflow obstruction) n= 117 (No airflow reversibility)
  7. 7. Population Definition Summary Clinical diagnosis of Asthma N=857 Aged ≥40 years N=755 Evidence of smoking N=429 Airflow Obstruction (Post BD FEV1 per cent predicted or FEV1/FVC <0.7) N=157 Airflow Reversibility (≥12% and ≥200mL increase in post- bronchodilator FEV1) N=109 Subgroup C3 Subgroup C2 Subgroup C1 Subgroup C POPULATION C n= 102 (Patient is <40 years) n= 326 (No evidence of smoking – current or ex) n= 272 (No airflow obstruction) n= 48 (No airflow reversibility)
  8. 8. ACO prevalence in the clinical populations Population A Clinical diagnosis of COPD only Population B Clinical diagnosis of Asthma & COPD Population C Clinical diagnosis of Asthma only ACO prevalence 20.5% (208/1,015) 32.1% (127/395) 14.4% (109/755) p-value compared to asthma and COPD* p<0.001 Reference p<0.001 *Chi-squared test REG ACO WG defined ACO as: 1) Current or former smoking 2) Post-bronchodilator airflow obstruction 3) At least partial reversibility in airflow obstruction
  9. 9. Clinical characteristics of patients with ACO identified within each clinical population Total ACO (n=444) A COPD only (n=208) B Asthma and COPD (n=127) C Asthma only (n=109) p-value for each pair- wise comparison A vs. B A vs. C B vs. C Age Years, mean (SD) 70.0 (10.6) 72.0 (10.1) 68.4 (10.5) 68.1 (11.1) 0.04 0.04 0.73 Gender Male 264 (59.5) 131 (63.0) 71 (55.9) 62 (56.9) 0.20 0.30 0.8 Female 180 (40.5) 77 (37.0) 56 (44.1) 47 (43.1) Smoking history Current smoker 118 (26.6) 60 (28.9) 39 (30.7) 19 (17.4) 0.72 0.03 0.02 Former smoker 326 (73.4) 148 (71.1) 88 (69.3) 90 (82.6) BMI Underweight 15 (3.4) 11 (5.3) 2 (1.6) 2 (1.8) 0.03 0.01 0.72 Healthy weight 136 (30.6) 76 (36.5) 36 (28.4) 24 (22.0) Overweight 160 (36.0) 73 (35.1) 44 (34.7) 43 (39.5) Obese 133 (30.0) 48 (23.1) 45 (35.4) 40 (36.7)
  10. 10. Clinical characteristics of patients with ACO identified within each clinical population Total ACO (n=444) A COPD only (n=208) B Asthma and COPD (n=127) C Asthma only (n=109) p-value for each pair-wise comparison A vs. B A vs. C B vs. C Comorbidities Cardiovascular disease 161 (36.3) 81 (38.9) 38 (29.9) 42 (38.5) 0.10 0.94 0.16 Ischaemic heart disease 91 (20.5) 48 (23.1) 23 (18.1) 20 (18.4) 0.28 0.33 0.96 Heart failure 21 (4.7) 12 (5.6) 6 (4.7) 3 (2.8) 0.68 0.23 0.43 Hypertension 134 (30.2) 66 (31.7) 34 (26.8) 34 (31.2) 0.34 0.92 0.46 Myocardial infarction 34 (7.7) 17 (8.2) 10 (7.9) 7 (6.4) 0.92 0.58 0.67 Cerebrovascular disease 27 (6.1) 15 (7.2) 4 (3.2) 8 (7.3) 0.12 0.97 0.14 Rhinitis 95 (21.4) 36 (17.3) 23 (18.1) 36 (33.0) 0.85 <0.01 0.01 Eczema 101 (22.8) 50 (24.0) 24 (18.9) 27 (24.8) 0.27 0.90 0.27 Bronchiectasis 18 (4.1) 10 (4.8) 6 (4.7) 2 (1.8) 0.97 0.20 0.22 Diabetes 236 (53.2) 112 (53.9) 64 (50.4) 50 (55.1) 0.54 0.84 0.47 Gastroesophageal reflux 81 (18.2) 38 (18.3) 21 (16.5) 22 (20.2) 0.69 0.68 0.88 Osteoporosis 41 (9.2) 20 (9.6) 14 (11.0) 7 (6.4) 0.68 0.33 0.22 Chronic kidney disease 51 (11.5) 30 (14.4) 14 (11.0) 7 (6.4) 0.37 0.04 0.21 Anxiety or depression 37 (8.3) 16 (7.7) 10 (7.9) 11 (10.1) 0.95 0.47 0.51
  11. 11. Conclusions • In primary care, approximately 20% of individuals with a diagnosis of COPD, asthma, or both have ACO based on the REG ACO WG criteria. • The prevalence and characteristics of patients meeting the REG ACO criteria varied across the chronic respiratory disease subpopulations, suggesting that ACO in this setting is likely to represent a heterogeneous set of conditions.
  12. 12. 2) Discussion on progressing future projects a) Implications of a mixed asthma-COPD phenotype vs COPD alone on patient outcomes, using OPCRD patients in the proof of concept study b) Evaluation of ACO definitions in other national databases
  13. 13. Implications of a mixed asthma-COPD phenotype vs COPD alone on patient outcomes
  14. 14. Specifically: • To identify the prevalence and incidence of patients diagnosed as having ACO • To identify the burden and cost of ACO compared with COPD and asthma populations • To assess respiratory and cardiovascular outcomes in ACO, COPD, asthma treated with ICS, ICS/LABA and LABA. • Characterise ACO patients to aid the development of a diagnostic tool Assess the implications of a diagnosis of ACO vs COPD alone on patient outcomes, using OPCRD patients from the proof of concept study Objective
  15. 15. Clinical Outcomes I • Historical “onset” of disease: o Duration of asthma (time between first recorded asthma diagnosis / encounter and year of study) o Duration of COPD (time between first recorded COPD diagnosis / encounter and year of study) o Time between first recorded asthma diagnosis/encounter and first COPD diagnosis/encounter • Smoking history: o Pack years o Duration of smoking: – Ex-smokers (time between first current/active smoking code and non- smoker or smoking cessation code) – Current smokers (time between first current/active smoking code and year of study)
  16. 16. Clinical Outcomes II • Presence of atopy, defined as ≥1 of the following: o Physician diagnosis of eczema or allergic rhinitis o Eosinophilia (cut off >200/μl; REG COPD blood eosinophilia study used ≥450μl) o Positive skin prick test o Positive to ≥1 allergen • COPD severity: GOLD status • Comorbidities: o Cardiovascular disease o Other chronic respiratory conditions o Diabetes o Gastroesophageal reflux disease (GERD) o Charleson Comorbidity Index o Lung Cancer
  17. 17. Clinical Outcomes III • Respiratory treatment: Prescriptions/ claims data, during phase 1 24-month evaluation period, for the following, and combinations of: o SABA o SAMA o LABA o LAMA o ICS o theophylline o LTRA o Roflumilast o Chronic azithromycin • Exacerbations: Functional consequences of different definitions, (i) proportion of patients and (ii) annualised rate of respiratory-related exacerbations over the phase 1 24-month evaluation period: o Physician diagnosis of asthma or COPD exacerbation; o A & E/ Emergency Room attendance with a lower respiratory code o Hospital admission with a lower respiratory code o Course of prednisolone o Course of systemic antibiotics coded for a lower respiratory tract infection
  18. 18. Evaluation of the ACO definitions in other national databases
  19. 19. Database eligibility criteria Inclusion: • Must be “population-based”, requiring them to be largely representative of the broad, heterogeneous population treated within everyday routine care in their respective country of origin. The following types of population-based databases may be eligible: o Clinical databases (e.g. primary care databases) o Administrative/billing-based (e.g. insurance claims records) • Have at least two continuous years of “recent” (within the last 10 years: 2006-2015) clinical data • Have produced at least one publication in a peer reviewed journal • Include variables permitting: o Evaluation of patient age (i.e. patient age or date/year of birth) o Evidence of current or past smoking (e.g. smoking status, pack years, prescription of smoking cessation therapy/advice). Exclusion: • To maximise the external validity of the study findings and avoid biasing outcomes by working within pre-selected populations unrepresentative of the diversity of patients managed in routine clinical practice, the following will not be eligible for inclusion in the initial phase of this study: o Clinical trials databases o Case series of patients
  20. 20. Which databases should be included in the protocol? DATABASE Time for completion of Stage 1 Cost for completion of Stage 1 1. Dutch ASTHMA / COPD Service 8 weeks EUR 10,000 (~2 months post-doc salary) 2. Adelphi Respiratory Disease Specific Programme ≤ 4 weeks £0 3. Optimum Patient Care Research Database (OPCRD) 4-6 weeks £10,000 4. SIDIAP 6 weeks EUR 1,500 5. MAJORICA TBC TBC 6. PCORnet Common Data Model Data available Sept 2016; analysis estimate ? TBC 7. HealthCore 3 weeks $4,167 (if manual programming required) 8. MarketScan "1 day" ? 9. Optum Humedica "1 day" ? ? ✓ X Valuable for repeat analysis and validation when available
  21. 21. • Are there any databases with free access we could use as a starting point? • Which databases we could get the most out of? • Who are potential funders? • Will it be possible to share some of the data? It is likely analysis will need to be done at multiple sites, so who can provide analytically support? Next steps
  22. 22. 3) Any new ideas for projects

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