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COPD WORKING
GROUP MEETING
– COPD CONTROL STUDY UPDATE
– OTHER RESEARCH IDEAS
CHAIR: Marc Miravitlles
DATE: Saturday September 3rd
TIME: 13.45–14.45
VENUE: Royal College of General Practitioners;
30 Euston Square, London, UK
Agenda
13.45-14.30 COPD Control
– UK Pilot
– Spanish Prospective Studies
– International Prospective Validation Trial
14.30-14.45 Other Research Ideas & Group Discussion
– Real-life WISDOM
– Natural History of Alpha-1 Antitrypsin Deficiency
(UK database study)
PROSPECTIVE VALIDATION OF
COPD CONTROL
MARC MIRAVITLLES
13.45–14.30
Background (I)
•  The concept of disease control has been extensively developed in asthma;
less so in COPD… traditionally
•  A new definition of COPD has recently
been proposed, defined as the product
of two components:
o  Impact of the condition
o  Its clinical stability
•  Controlled COPD = stable low impact disease (i.e. low impact over time)
•  The concept of COPD control is intended as a:
o  Complementary management tool
o  Tool to support day-to-day management decisions in routine care
•  Its utility practical requires validation in routine care
Low
clinical impact
Clinical control
Stability
Impact High
clinical impact
Cross-sectional evaluation
of impact
Stability
(Improvement or
absence of changes)
Inestability
(Clinical worsening)
V1 V2 V3 V4
Cross-sectional, non-interventional database study using the
Optimum Patient Care Research Database (OPCRD) as a
lead-in to the prospective trials
UK Database pilot
Validation of concept study:
Aims:
•  Characterize COPD patients treated in UK routine primary care in terms
of their COPD control
•  Evaluate the clinical implications of control status
Data sources:
•  The UK’s Optimum Patient Care Research Database
(OPCRD)
•  Fully anonymised UK primary care data
•  Historical medical records for >2.5 million patients from
>550 primary care practices across the UK
•  Ethical approval for medical research & used for multiple
peer-review publications
Study Design:
•  Baseline: 3-month period for COPD stability assessment
•  Index date: the date of receipt of the patients completed COPD Assessment
Test (CAT) and date of Baseline COPD Control Assessment
•  Outcome: 12-months (primary) and 3-months (secondary)
12-months (primary)
outcome period
Index date:
Date of receipt of patients completed
COPD questionnaire / CAT score &
date of “Baseline Control” evaluation
Time to first COPD exacerbation
3-month
baseline period
COPD Stability
Assessment
(exacerbation
evaluation)
3-month
(secondary)
outcome period
Inclusion/Exclusion Criteria:
Inclusion Criteria
COPD diagnosis (physician-diagnosed COPD),
Aged ≥40 years
Current or ex-smokers
Recorded COPD Questionnaire data
•  ≥3 months continuous clinical records immediately prior to the index date
•  ≥1 year of continuous clinical records immediately following the index date
Exclusion Criteria
Any chronic respiratory condition other than COPD, asthma or bronchiectasis
(e.g. cystic fibrosis, lung fibrosis)
Patients with potential severe comorbidity at index date, defined as those with a
recorded data of death within the 24 months following index date
1
Exclusion criteria
Inclusion criteria
OPCRD- Patient completed a
COPD questionnaire
n=14,173
Valid period
n=4,530
Patients completed a COPD
questionnaire
COPD diagnosis
n=4,410
Age
n=4,400
No other chronic respiratory
disease
n=4,333
Current or ex-smoker
n=3,683
3 months of baseline and 12 months
of outcome data available
Physician-diagnosed COPD and
spirometry confirmed-COPD
Age ≥40 at index date
No chronic respiratory condition
other than COPD, asthma or
bronchiectasis
Valid period unavailable
n=9,643
No COPD diagnosis code or
spirometry confirmed definition
n=120
Aged <40 at index date
n=10
Chronic respiratory condition other
than COPD, asthma or
bronchiectasis
n=67
Recorded as current or ex-smoker
Non-smoker
n=650
No severe comorbidity
n=3,549
No death date recorded or death
date 24 months or more after index
date Patients with potential severe
comorbidity at index date
n=134
Final Patient Cohort
n=2788
Mild to moderate
(BODEx ≤4)
n=2511
Recorded data to assess impact and
stability criteria 1
Patients did not have data to assess
impact and/or stability criteria
n=761
Severity assessment: BODEx
stratification
Severe to very
severe (BODEx ≥5)
n=277
Patient Population
Definition of COPD Control
Mild/Moderate COPD: Control status
BODEx ≤4
Mild/Moderate
(n=2511)
Impact
(cross-sectional)
(i) Clinical Features
Low impact
(n=126)
Stability
(temporal)
No changes
(0 exacerbations)
Controlled (n=112)
Worsening
(≥1 exacerbations)
Uncontrolled (n=14)
High Impact
(n=2385)
Uncontrolled
(n=2385)
(ii) CAT Score
Low Impact
(n=633)
Stability
(temporal)
No changes
(0 exacerbations)
Controlled (n=541)
Worsening
(≥1 exacerbations)
Uncontrolled (n=92)
High Impact
(n=1878)
Uncontrolled
(n=1878)
Characteristics by Control status:
Mild/Moderate COPD
Severe / Very Severe COPD: Control status
BODEx ≥5
Severe/Very severe
(n=277)
Impact
(cross-sectional)
(i) Clinical Features
Low impact
(n=0)
High Impact
(n=277)
Uncontrolled
(n=277)
(ii) CAT Score
Low Impact
(n=71)
Stability
(temporal)
No changes
(0 exacerbations)
Controlled (n=23)
Worsening
(≥1 exacerbations)
Uncontrolled (n=48)
High Impact
(n=206)
Uncontrolled
(n=206)
Characteristics by Control status:
Severe/Very Severe COPD
Control Status & Time to First Exacerbation
Control Status & Time to First Exacerbation
0.000.250.500.751.00
CumulativeProportionSurviving
0 100 200 300 400
Time (days) to first exacerbation
Controlled
Uncontrolled
0.000.250.500.751.00
CumulativeProportionSurviving
0 100 200 300 400
Time (days) to first exacerbation
Controlled
Uncontrolled
B. Mild/Moderate COPD
Low impact based on CAT score (p<0.001)
A. Mild/Moderate COPD
Low impact based on Clinical Features (p<0.001)
0.000.250.500.751.00
CumulativeProportionSurviving
0 100 200 300 400
Time (days) to first exacerbation
Controlled
Uncontrolled
C. Severe/Very Severe COPD
Low impact based on CAT score (p=0.825)
No severe/very severe patients
were controlled at baseline based
on their clinical features
Next steps
•  Manuscript in preparation
•  ERS poster being presented tomorrow:
o  Sunday Sept 4th: 12.5014.40 by Dr Juan Jose Soler-Cataluna
o  Thematic Poster Session: Comorbidities and Exacerbations in COPD
STUDY 1: changes in control vs changes in severity over 6 months
STUDY 2: comparison of control and symptoms over 6 months
Observational Pilot Work in Spain
Study 1: changes in control vs severity
•  Objectives
o  Compare variability in control with variability in
severity (FEV1 and BODE/BODEx) over a 6-month
observational outcome period.
•  Update
o  44 centers and 393 patients included
o  LPLV 30/09/2016
o  Results expected by the end of 2016
Study 2: comparison of symptoms & control
•  Objectives
o  Compare the changes in control with the prevalence
and changes in EXACT Respiratory Symptoms
(E-RS).
•  Update
o  Sample size 144 patients
o  Follow-up 6 months
o  FPFV 01/06/2016
International Prospective
Validation Study
Multicenter, international and prospective study to validate the
concept of control in COPD and its implications for clinical
practice
Hypothesis
Control in COPD is a new conceptual dimension requiring
demonstration of both low impact and clinical stability. The
developers of the concept hypothesize that a status of
control in COPD will be associated with better clinical
outcomes (reduced frequency of exacerbations and
mortality and improved health-related quality of life);
reduced rate of decline in lung function and/or BODE/
BODEx and reduced direct COPD-related healthcare
costs.
Objectives
Primary: to evaluate, in an international cohort of routine care/
unselected COPD patients, the:
•  Levels of COPD control (vs poor COPD control), and
•  Clinical implications of control status.
Secondary:
•  Compare the utility of the COPD Control (as defined) as a tool to
identify COPD impact and stability with the CAT and CCQ;
•  Evaluate the role of “adequate” (i.e. guideline-recommended) treatment
prescribing on COPD control.
•  Identify demographic and clinical characteristics associated with COPD
control status
•  Evaluate the cost-utility of patients with controlled (as compared to
poorly controlled) COPD.
Eligibility: inclusion criteria
Eligible patients must meet the following inclusion criteria:
•  Spirometry-defined COPD (i.e. post-bronchodilator FEV1/
FVC<0.7)
•  Age ≥40 years
•  Smokers or ex-smokers of at least 10 pack-years
•  In stable state (as judged by the investigator) at point of
recruitment
Eligibility: exclusion criteria
Patients will be excluded from the trial they:
•  Have any chronic concomitant respiratory condition other
than asthma or bronchiectasis (e.g. cystic fibrosis, lung
fibrosis)
•  Have severe comorbidity with a life expectancy shorter
than 2 years
•  Are unable to understand the instructions of the study or to
fill the questionnaires
•  Are unwilling to sign the informed consent
•  Are participating in another clinical study or clinical trial.
Endpoints: primary
Difference between patients controlled vs uncontrolled at
baseline in (annualized) rates of the composite endpoint:
•  Unscheduled visits to the physician or emergency room
attendance for COPD
•  An exacerbation of COPD
•  All-cause: hospitalization or mortality
Endpoints: secondary
•  Difference between patients controlled vs uncontrolled at baseline in terms of:
o  The (annualized) rate of exacerbations
o  Time to the first composite event
o  Time to the first exacerbations
•  Comparison of CAT and CCQ as tools to identify impact and stability in COPD
•  Distribution of control level across in those receiving guideline vs non-
guideline recommended therapy (i.e. stratification of control across different
treatment groups)
•  Demographic and clinical characteristics associated with poor control of
COPD
•  Differences in utilities between patients controlled and uncontrolled
(measured by the EQ-5D).
Design: prospective non-interventional
21 months prospective pragmatic trial, comprising 5 evaluation
points: one screening evaluation and 4 follow-up evaluations
3 months 6 months
(9 months from
screening visit)
6 months
(15 months from
screening visit)
6 months
(21 months from
screening visit)
Visit -1
(Screening visit)
Visit 0
(Screening visit)
Visit 1
(Follow-up visit)
Visit 2
(Follow-up visit)
Visit 3
(Follow-up visit)
Clinician-guided (“usual care”) treatment throughout the study
Screening
assessment
Baseline
assessment
Control
1
Control
2
Control
3
Visit Summary
Visit number -1 0 1, 2 and 3
Time of Visit Inclusion
Baseline
3 months
9, 15 and 21 months or
discontinuation
Inclusion/Exclusion criteria ✔
Information & Informed
consent ✔
Clinical assessment ✔ ✔ ✔
Assessment of
exacerbations since last
visit*
✔ ✔ ✔
Assessment of clinical
status since last visit
✔ ✔ ✔
CAT/CCQ/EQ-5D*
✔ ✔ ✔
Adverse events ✔ ✔
!
Data capture by e-CRF
Data capture
by e-CRF
Recruitment
•  Study power:
o  ≥285 patients are required to power the primary endpoint
o  >285 patients may will permit subgroup analyses to be
conducted and give sufficient power to evaluated significant
differences in some of the secondary endpoints
o  Total patient recruitment = 328 (to allow for ~12% drop outs)
•  Recruitment distribution:
o  To include ≥6 countries
o  To recruit ~50 patients per country
o  To achieve ~even distribution between national contributions
Recruiting Investigators & Centres
Country Site Name Principal Investigator Status
Ireland Royal College of Surgeons, Dublin Richard Costello Recruiting
Spain
Pneumology Department, Vall d' Hebron University
Hospital, Barcelona
Marc Miravitlles Recruiting
Pneumology Department, Hospital Arnau de Vilanova,
Valencia, Spain
Juan José Soler-Cataluña Recruitment still to commence
Respiratory Department, Hospital de Alta Resolucion,
Granada
Bernardino Alcazar Navarrete Recuiting
Instituto de Investigacíon Sanitaria de Palma (IdISPa),
Palma de Mallorca, Spain
Miguel Roman Rodriguez Recruiting
Singapore
Singapore General Hospital
Jessica Tan (formerly Therese
Lapperre)
Recuiting
Changi General Hospital (CGH) Augustine Tee Recruiting
Korea Department of Internal Medicine, Seoul St. Mary's Hospital Chin Kook Rhee Recruiting
UK Optimum Patient Care Clinical Review Service David Price
Recruitment still to commence
(targeted service to run in
October)
Poland
Institute of Tuberculosis and Lung Diseases, Warsaw,
Poland
Pawel Sliwinski Recruitment complete
Canada Montreal Chest Institute, Montreal, Quebec
Jean Bourbeau; Ron Dandurand;
Meena Patel
Withdrew – time delays owing
to hospital move
Timelines: Initial
*based on estimated completion Dec 2016
Study Element Initial Actual
Ethics & contracts October 2015–April 2016
Recruitment Oct 2015–July 2016 May 2016–ongoing
Complete data collection July 2018 December 2018*
Baseline cross-sectional impact
measurements
November 2016 January 2017*
Final report, including longitudinal
study and control measurements
December 2018 March 2019*
Baseline characteristics January 2017 May 2017*
Final manuscript April 2019 October 2019*
Recruitment to date (May-Aug)
Total enrolled (26 August) 2016
20-
May-16
27-
May-16
07-
Jun-16
17-
Jun-16
23-
Jun-16
29-
Jun-16
08-
Jul-16
15-
Jul-16
25-
Jul-16
05-
Aug-16
11-
Aug-16
19-
Aug-16
26-
Aug-16
Site
Totals
Spain 0 0 8 4 5 7 5 1 7 0 0 0 0 37
Ireland 1 2 3 4 3 5 5 1 3 1 2 1 1 31
South Korea 0 1 6 0 0 0 0 18 9 2 0 0 0 36
Singapore 0 3 7 2 6 1 0 4 8 4 5 9 1 50
Poland 0 0 0 0 0 0 0 14 34 0 0 3 3 51
UK 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0
10
20
30
40
50
60
Numberofpatients
Recruitment by Country by country by week
0
50
100
150
200
250
Totalpatientnumber
20-
May-16
27-
May-16
07-Jun-16 17-Jun-16 23-Jun-16 29-Jun-16 08-Jul-16 15-Jul-16 25-Jul-16 05-Aug-1611-Aug-16 19-Aug-1624-Aug-16
Series1 1 7 31 41 55 68 78 116 177 184 191 205 208
Recruitment (May–August)
64% of total
n=208 of 328
Current status
•  64% of total (n=208 of 328)
•  UK Service to commence ~October
•  Recruitment estimated to conclude by December
2016
•  Baseline assessments for first patients now
commencing
Real-time Study Tracker (II)
Planned Revisions:
•  Include UK
•  Update data for Poland
•  Include baseline visit data
Real-time Study Tracker (II)
Planned Revisions: Colour-match trend lines with regional location indicators to
help identify geographical origin of patients recruited to date
ICS Cessation in COPD:
‘Real-Life WISDOM’
DIRKJE POSTMA & HELGO MAGNUSSEN
FOR DISCUSSION
FUNDING…?
Background – ICS use in COPD
•  Studies seeking to address whether combination ICS/LABA
therapy improves COPD stability have traditionally concluded
that withdrawal of ICS therapy is associated with:1–3
o  An increase in exacerbations and symptoms;
o  Reduction in health-related quality of life
o  An acceleration in lung function decline.
•  Investigators have also concluded that ICS lack sustained
disease-modifying effects after ICS cessation following a
recent comparative study of lung function decline, AHR, and
QOL over a 5-year follow-up period.4
1. Wouters EF, et al. Thorax. 2005;60:480-7; 2. Lapperre TS, et al. Ann Intern Med. 2009 Oct
20;151:517-27. 3. van der Valk P, et al. Am J Respir Crit Care Med. 2002;166:1358-63;
4. Kunz LI, et al. Chest. 2015;148:389-96.
Background – WISDOM
•  WISDOM evaluated the effect of gradual ICS withdrawal in COPD
patients (n=2485) on triple therapy (ICS/tio/salmeterol) within an
RCT environment and observed that:
o  Exacerbation rates were similar in patients continuing versus discontinuing
ICS therapy
o  No significant differences in outcomes between ICS withdrawal and triple
therapy patients across subgroups in which a greater degree of dependence
on ICS might be expected
o  No significant between group difference in the rate of dropout
o  However… a greater decrease in lung function decline was observed in
patients discontinuing ICS therapy in the final step
of ICS withdrawal.
1. Magnussen H, et al. NEJM. 2014;371:1285-94.
Study Concept
•  The aim of the study is to evaluate the effect of
ICS cessation (and reduced ICS exposure) on
COPD lung function (and exacerbation rates) in
patients with COPD managed in a routine care,
“real-life” setting.
Design: overview
Using electronic
primary care
records data
from the UK’s
Optimum Patient
Care Research
Database
(OPCRD), the
study will include
2 x matched
analysis.
Index date
Cohort A – Control Arm: continue on baseline therapy
(no MPR restrictions)
Baseline
Patients on FDC ICS/LABA and
separate LAMA
ICS MPR ≥70%
1 year 1 year
Annual exploratory endpoints to 5
years post index date
Month
-12
Month
-6
Month
12
Month
13
Month
……………………………..60
Month
0
Month
3
Cohort A – Cessation Arm:
LABA / LAMA therapy
(any combination of fixed or separate inhaler devices)
No ICS prescriptions fro ≥3 months (i.e. prior to month 3)
ICS Cessation Cohort
ICS Reduction Cohort
Index date
Cohort B – Control Arm: continue on baseline
therapy (at no or <50% reduction in ICS dose)
Baseline
Patients on:
ICS/LABA/LAMA
(any fixed or free combinations)
ICS MPR ≥70%
1 year 1 year
Annual exploratory endpoints to 5
years post index date
Month
-12
Month
-6
Month
12
Month
13
Month
……………………………..60
Month
0
Month
3
Cohort B – Reduction Arm (prescribed): continue on
baseline therapy but with ICS prescribed at ≥50%
reduced dose
Outcome Period & Endpoints
Outcome period:
•  Primary: 1 year
•  Exploratory:
o  24 months; 36 months; 48 months, 60 months1
o  12-weeks (where evaluable) as used in WISDOM2
Primary endpoints
•  Time to first acute COPD exacerbation
Secondary endpoints
•  Exacerbation rate
•  Change in FEV1
•  Treatment stability (absence of exacerbations and no escalation in
pharmacotherapy)
•  COPD-related hospitalisations (rate and time to first)
1. Kunz LI, et al. Chest. 2015;148:389-96;
2. Magnussen H, et al. NEJM. 2014;371:1285-94;
Interaction analyses
The interaction between the follow patient / clinical
features and the study outcomes will be explored
where feasible:
•  Baseline blood eosinophil level
•  Baseline exacerbation rate
•  Presence of atopy
•  Smoking status (current vs ex-)
•  Prescribed baseline ICS particle size (extra-fine vs non-
extra-fine)
Feasibility: OPCRD Patient #s
COPD patients Number*
COPD diagnosis ever 132,962
On Triple Therapy
(≥1 prescription for ICS, LAMA and LABA in latest
12-month period)
25,987
On triple therapy and discontinue ICS
(on prescription of ICS, LABA and LAMA in baseline with
only LABA and LAMA in outcome (using any LABA/LAMA
prescription as index date)
687
On triple therapy and discontinue ICS* with ≥1 FEV1
during baseline year and FEV1 reading in the 0-5 years
following ICS cessation/reduction
356
*Numbers valid as of September 2015 and will be substantially
higher by the time of extraction.
MODERN EPIDEMIOLOGY OF ALPHA1-
ANTITRYPSIN DEFICIENCY (AATD) IN THE UK
JOAN SORIANO, RAVI MAHADEVA, MARC MIRAVITLLES
AND RUPERT JONES
FOR DISCUSSION
FUNDING…?
Background
•  Emphysema in AATD results from an excess of neutrophil elastase in the lung, which
destroys elastin and the elastase inhibitor AAT that protects against proteolytic
degradation of elastin.1
•  Cigarette smoking and infection also increase elastase production in the lung, thus
increasing lung degradation.1
•  AATD is considered a rare disease, but it is believed to be largely underdiagnosed2
•  3.4 million individuals in the world have an AATD genotype that leads to a deficiency of
this protein2
•  Previous estimates of AATD prevalence in the UK are outdated; current prevalence of is
unknown.3–7
•  Large UK databases (e.g. the CPRD and OPCRD) have been used to evaluate the
prevalence of COPD and asthma within the UK; little work in AATD has been conducted.7
•  The National Institute for Health and Care Excellence in the UK is currently reconsidering
and reviewing his AATD treatment and management recommendations8
1. Stoller JK, et al. Am J Respir Crit Care Med 2012; 185:246; 2. de Serres FJ, et al. Chest 2002;122:1818–1829;
3. Hutchison DC, et al. Clin Sci 1970;38:19P; 4. Cook PJ, et al. Ann Hum Genet 1975;38:275-87; 5. Hutchison DC, et al. Bull
Eur Physiopathol Respir 1980;16 Suppl:315-9; 6. Hutchison DC. Lung 1990;168 Suppl:535-42; 7. Jones RJ, et al. LRM.
2014;2:267-76; 8. NICE. Proposed HTA Human alpha1-proteinase inhibitor for treating emphysema Draft scope (pre-referral);
March 2016;
Study Aim
•  To determine the epidemiological trends
(1990-2015) of Alpha1-antitrypsin deficiency
(AATD) in the UK, and its natural history in the
population:
o  Size of the problem
o  Prevalence
o  Incidence
o  Mortality from 1990 to 2015
•  To benchmark AATD with other respiratory and
non-respiratory conditions
Data sources
•  A combined dataset of patients from two UK
primary care databases (de-duped) will be used:
o  Clinical Practice Research Database
o  Optimum Patient Care Research Database (OPCRD)
•  Subpopulation data links – where available:
o  Rates of hospitalisations and day cases of treatment for AATD
will be assessed in patients with linked Hospital Episode
Statistics (HES) data
o  Mortality rate and cause of death will be assessed in patients
with linked Office of National Statistics (ONS) data
Patient Population: inclusion criteria
To be eligible for inclusion in the study, patients must meet the following
criteria, for each population group:
•  AATD Population: Physician-diagnosed AATD (presence of a AATD
Read code, ever)
•  COPD Population: Physician-diagnosed COPD (presence of a
COPD Read code) and/or spirometry-defined COPD: post-
bronchodilator FEV1/FVC<0.7
•  General Population: Healthy control individuals, or patients with
non-severe morbidities randomly identified
Outcomes
Co-Primary endpoints (stratified by year)
•  AATD Incidence
•  AATD Prevalence
•  AATD mortality rates.
Secondary endpoints
•  Respiratory exacerbations
•  Oral steroids courses
•  Inpatient hospitalisations for AATD
o  Respiratory, liver, or other, as per HES statistics
•  Day cases for AATD treatment
•  Other clinical outcomes of particular interest include:
o  Oxygen saturation, imaging, Charlson index, mMRC dyspnoea, …
Subgroup of AATD patients with liver disease:
•  Child-Pugh score
But first… a pilot
Data source: OPCRD only (no linked
secondary or mortality data)
Population: AATD diagnosis only
(i.e. no matched comparisons)
Exploratory patient number: 100
Co-Primary endpoints (stratified by year)
•  AATD Incidence
•  AATD Prevalence
•  AATD mortality rates.
Secondary endpoints
•  Respiratory exacerbations
•  Oral steroids courses
•  Other clinical outcomes of particular
interest include:
o  Oxygen saturation, imaging,
Charlson index, mMRC dyspnoea
Cohort:
AATD
…1997 2000 2005 2010 2015
Case%1:"AATD,"Female."25"yrs,"Dx"in"2005;"exitus"in"2008"
Case%2:"AATD,"Male"45"yrs.,"Dx"in"2010"
Figure%1:"Study"Design"Diagram"(exploratory)""
(exploratory,"with"two"extreme"AATD"case"examples)"

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COPD Working Group Meeting

  • 1. COPD WORKING GROUP MEETING – COPD CONTROL STUDY UPDATE – OTHER RESEARCH IDEAS CHAIR: Marc Miravitlles DATE: Saturday September 3rd TIME: 13.45–14.45 VENUE: Royal College of General Practitioners; 30 Euston Square, London, UK
  • 2. Agenda 13.45-14.30 COPD Control – UK Pilot – Spanish Prospective Studies – International Prospective Validation Trial 14.30-14.45 Other Research Ideas & Group Discussion – Real-life WISDOM – Natural History of Alpha-1 Antitrypsin Deficiency (UK database study)
  • 3. PROSPECTIVE VALIDATION OF COPD CONTROL MARC MIRAVITLLES 13.45–14.30
  • 4. Background (I) •  The concept of disease control has been extensively developed in asthma; less so in COPD… traditionally •  A new definition of COPD has recently been proposed, defined as the product of two components: o  Impact of the condition o  Its clinical stability •  Controlled COPD = stable low impact disease (i.e. low impact over time) •  The concept of COPD control is intended as a: o  Complementary management tool o  Tool to support day-to-day management decisions in routine care •  Its utility practical requires validation in routine care
  • 5. Low clinical impact Clinical control Stability Impact High clinical impact Cross-sectional evaluation of impact Stability (Improvement or absence of changes) Inestability (Clinical worsening) V1 V2 V3 V4
  • 6. Cross-sectional, non-interventional database study using the Optimum Patient Care Research Database (OPCRD) as a lead-in to the prospective trials UK Database pilot
  • 7. Validation of concept study: Aims: •  Characterize COPD patients treated in UK routine primary care in terms of their COPD control •  Evaluate the clinical implications of control status Data sources: •  The UK’s Optimum Patient Care Research Database (OPCRD) •  Fully anonymised UK primary care data •  Historical medical records for >2.5 million patients from >550 primary care practices across the UK •  Ethical approval for medical research & used for multiple peer-review publications
  • 8. Study Design: •  Baseline: 3-month period for COPD stability assessment •  Index date: the date of receipt of the patients completed COPD Assessment Test (CAT) and date of Baseline COPD Control Assessment •  Outcome: 12-months (primary) and 3-months (secondary) 12-months (primary) outcome period Index date: Date of receipt of patients completed COPD questionnaire / CAT score & date of “Baseline Control” evaluation Time to first COPD exacerbation 3-month baseline period COPD Stability Assessment (exacerbation evaluation) 3-month (secondary) outcome period
  • 9. Inclusion/Exclusion Criteria: Inclusion Criteria COPD diagnosis (physician-diagnosed COPD), Aged ≥40 years Current or ex-smokers Recorded COPD Questionnaire data •  ≥3 months continuous clinical records immediately prior to the index date •  ≥1 year of continuous clinical records immediately following the index date Exclusion Criteria Any chronic respiratory condition other than COPD, asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis) Patients with potential severe comorbidity at index date, defined as those with a recorded data of death within the 24 months following index date
  • 10. 1 Exclusion criteria Inclusion criteria OPCRD- Patient completed a COPD questionnaire n=14,173 Valid period n=4,530 Patients completed a COPD questionnaire COPD diagnosis n=4,410 Age n=4,400 No other chronic respiratory disease n=4,333 Current or ex-smoker n=3,683 3 months of baseline and 12 months of outcome data available Physician-diagnosed COPD and spirometry confirmed-COPD Age ≥40 at index date No chronic respiratory condition other than COPD, asthma or bronchiectasis Valid period unavailable n=9,643 No COPD diagnosis code or spirometry confirmed definition n=120 Aged <40 at index date n=10 Chronic respiratory condition other than COPD, asthma or bronchiectasis n=67 Recorded as current or ex-smoker Non-smoker n=650 No severe comorbidity n=3,549 No death date recorded or death date 24 months or more after index date Patients with potential severe comorbidity at index date n=134 Final Patient Cohort n=2788 Mild to moderate (BODEx ≤4) n=2511 Recorded data to assess impact and stability criteria 1 Patients did not have data to assess impact and/or stability criteria n=761 Severity assessment: BODEx stratification Severe to very severe (BODEx ≥5) n=277 Patient Population
  • 12. Mild/Moderate COPD: Control status BODEx ≤4 Mild/Moderate (n=2511) Impact (cross-sectional) (i) Clinical Features Low impact (n=126) Stability (temporal) No changes (0 exacerbations) Controlled (n=112) Worsening (≥1 exacerbations) Uncontrolled (n=14) High Impact (n=2385) Uncontrolled (n=2385) (ii) CAT Score Low Impact (n=633) Stability (temporal) No changes (0 exacerbations) Controlled (n=541) Worsening (≥1 exacerbations) Uncontrolled (n=92) High Impact (n=1878) Uncontrolled (n=1878)
  • 13. Characteristics by Control status: Mild/Moderate COPD
  • 14. Severe / Very Severe COPD: Control status BODEx ≥5 Severe/Very severe (n=277) Impact (cross-sectional) (i) Clinical Features Low impact (n=0) High Impact (n=277) Uncontrolled (n=277) (ii) CAT Score Low Impact (n=71) Stability (temporal) No changes (0 exacerbations) Controlled (n=23) Worsening (≥1 exacerbations) Uncontrolled (n=48) High Impact (n=206) Uncontrolled (n=206)
  • 15. Characteristics by Control status: Severe/Very Severe COPD
  • 16. Control Status & Time to First Exacerbation
  • 17. Control Status & Time to First Exacerbation 0.000.250.500.751.00 CumulativeProportionSurviving 0 100 200 300 400 Time (days) to first exacerbation Controlled Uncontrolled 0.000.250.500.751.00 CumulativeProportionSurviving 0 100 200 300 400 Time (days) to first exacerbation Controlled Uncontrolled B. Mild/Moderate COPD Low impact based on CAT score (p<0.001) A. Mild/Moderate COPD Low impact based on Clinical Features (p<0.001) 0.000.250.500.751.00 CumulativeProportionSurviving 0 100 200 300 400 Time (days) to first exacerbation Controlled Uncontrolled C. Severe/Very Severe COPD Low impact based on CAT score (p=0.825) No severe/very severe patients were controlled at baseline based on their clinical features
  • 18. Next steps •  Manuscript in preparation •  ERS poster being presented tomorrow: o  Sunday Sept 4th: 12.5014.40 by Dr Juan Jose Soler-Cataluna o  Thematic Poster Session: Comorbidities and Exacerbations in COPD
  • 19. STUDY 1: changes in control vs changes in severity over 6 months STUDY 2: comparison of control and symptoms over 6 months Observational Pilot Work in Spain
  • 20. Study 1: changes in control vs severity •  Objectives o  Compare variability in control with variability in severity (FEV1 and BODE/BODEx) over a 6-month observational outcome period. •  Update o  44 centers and 393 patients included o  LPLV 30/09/2016 o  Results expected by the end of 2016
  • 21. Study 2: comparison of symptoms & control •  Objectives o  Compare the changes in control with the prevalence and changes in EXACT Respiratory Symptoms (E-RS). •  Update o  Sample size 144 patients o  Follow-up 6 months o  FPFV 01/06/2016
  • 22. International Prospective Validation Study Multicenter, international and prospective study to validate the concept of control in COPD and its implications for clinical practice
  • 23. Hypothesis Control in COPD is a new conceptual dimension requiring demonstration of both low impact and clinical stability. The developers of the concept hypothesize that a status of control in COPD will be associated with better clinical outcomes (reduced frequency of exacerbations and mortality and improved health-related quality of life); reduced rate of decline in lung function and/or BODE/ BODEx and reduced direct COPD-related healthcare costs.
  • 24. Objectives Primary: to evaluate, in an international cohort of routine care/ unselected COPD patients, the: •  Levels of COPD control (vs poor COPD control), and •  Clinical implications of control status. Secondary: •  Compare the utility of the COPD Control (as defined) as a tool to identify COPD impact and stability with the CAT and CCQ; •  Evaluate the role of “adequate” (i.e. guideline-recommended) treatment prescribing on COPD control. •  Identify demographic and clinical characteristics associated with COPD control status •  Evaluate the cost-utility of patients with controlled (as compared to poorly controlled) COPD.
  • 25. Eligibility: inclusion criteria Eligible patients must meet the following inclusion criteria: •  Spirometry-defined COPD (i.e. post-bronchodilator FEV1/ FVC<0.7) •  Age ≥40 years •  Smokers or ex-smokers of at least 10 pack-years •  In stable state (as judged by the investigator) at point of recruitment
  • 26. Eligibility: exclusion criteria Patients will be excluded from the trial they: •  Have any chronic concomitant respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis) •  Have severe comorbidity with a life expectancy shorter than 2 years •  Are unable to understand the instructions of the study or to fill the questionnaires •  Are unwilling to sign the informed consent •  Are participating in another clinical study or clinical trial.
  • 27. Endpoints: primary Difference between patients controlled vs uncontrolled at baseline in (annualized) rates of the composite endpoint: •  Unscheduled visits to the physician or emergency room attendance for COPD •  An exacerbation of COPD •  All-cause: hospitalization or mortality
  • 28. Endpoints: secondary •  Difference between patients controlled vs uncontrolled at baseline in terms of: o  The (annualized) rate of exacerbations o  Time to the first composite event o  Time to the first exacerbations •  Comparison of CAT and CCQ as tools to identify impact and stability in COPD •  Distribution of control level across in those receiving guideline vs non- guideline recommended therapy (i.e. stratification of control across different treatment groups) •  Demographic and clinical characteristics associated with poor control of COPD •  Differences in utilities between patients controlled and uncontrolled (measured by the EQ-5D).
  • 29. Design: prospective non-interventional 21 months prospective pragmatic trial, comprising 5 evaluation points: one screening evaluation and 4 follow-up evaluations 3 months 6 months (9 months from screening visit) 6 months (15 months from screening visit) 6 months (21 months from screening visit) Visit -1 (Screening visit) Visit 0 (Screening visit) Visit 1 (Follow-up visit) Visit 2 (Follow-up visit) Visit 3 (Follow-up visit) Clinician-guided (“usual care”) treatment throughout the study Screening assessment Baseline assessment Control 1 Control 2 Control 3
  • 30. Visit Summary Visit number -1 0 1, 2 and 3 Time of Visit Inclusion Baseline 3 months 9, 15 and 21 months or discontinuation Inclusion/Exclusion criteria ✔ Information & Informed consent ✔ Clinical assessment ✔ ✔ ✔ Assessment of exacerbations since last visit* ✔ ✔ ✔ Assessment of clinical status since last visit ✔ ✔ ✔ CAT/CCQ/EQ-5D* ✔ ✔ ✔ Adverse events ✔ ✔ !
  • 33. Recruitment •  Study power: o  ≥285 patients are required to power the primary endpoint o  >285 patients may will permit subgroup analyses to be conducted and give sufficient power to evaluated significant differences in some of the secondary endpoints o  Total patient recruitment = 328 (to allow for ~12% drop outs) •  Recruitment distribution: o  To include ≥6 countries o  To recruit ~50 patients per country o  To achieve ~even distribution between national contributions
  • 34. Recruiting Investigators & Centres Country Site Name Principal Investigator Status Ireland Royal College of Surgeons, Dublin Richard Costello Recruiting Spain Pneumology Department, Vall d' Hebron University Hospital, Barcelona Marc Miravitlles Recruiting Pneumology Department, Hospital Arnau de Vilanova, Valencia, Spain Juan José Soler-Cataluña Recruitment still to commence Respiratory Department, Hospital de Alta Resolucion, Granada Bernardino Alcazar Navarrete Recuiting Instituto de Investigacíon Sanitaria de Palma (IdISPa), Palma de Mallorca, Spain Miguel Roman Rodriguez Recruiting Singapore Singapore General Hospital Jessica Tan (formerly Therese Lapperre) Recuiting Changi General Hospital (CGH) Augustine Tee Recruiting Korea Department of Internal Medicine, Seoul St. Mary's Hospital Chin Kook Rhee Recruiting UK Optimum Patient Care Clinical Review Service David Price Recruitment still to commence (targeted service to run in October) Poland Institute of Tuberculosis and Lung Diseases, Warsaw, Poland Pawel Sliwinski Recruitment complete Canada Montreal Chest Institute, Montreal, Quebec Jean Bourbeau; Ron Dandurand; Meena Patel Withdrew – time delays owing to hospital move
  • 35. Timelines: Initial *based on estimated completion Dec 2016 Study Element Initial Actual Ethics & contracts October 2015–April 2016 Recruitment Oct 2015–July 2016 May 2016–ongoing Complete data collection July 2018 December 2018* Baseline cross-sectional impact measurements November 2016 January 2017* Final report, including longitudinal study and control measurements December 2018 March 2019* Baseline characteristics January 2017 May 2017* Final manuscript April 2019 October 2019*
  • 36. Recruitment to date (May-Aug) Total enrolled (26 August) 2016 20- May-16 27- May-16 07- Jun-16 17- Jun-16 23- Jun-16 29- Jun-16 08- Jul-16 15- Jul-16 25- Jul-16 05- Aug-16 11- Aug-16 19- Aug-16 26- Aug-16 Site Totals Spain 0 0 8 4 5 7 5 1 7 0 0 0 0 37 Ireland 1 2 3 4 3 5 5 1 3 1 2 1 1 31 South Korea 0 1 6 0 0 0 0 18 9 2 0 0 0 36 Singapore 0 3 7 2 6 1 0 4 8 4 5 9 1 50 Poland 0 0 0 0 0 0 0 14 34 0 0 3 3 51 UK 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 10 20 30 40 50 60 Numberofpatients Recruitment by Country by country by week
  • 37. 0 50 100 150 200 250 Totalpatientnumber 20- May-16 27- May-16 07-Jun-16 17-Jun-16 23-Jun-16 29-Jun-16 08-Jul-16 15-Jul-16 25-Jul-16 05-Aug-1611-Aug-16 19-Aug-1624-Aug-16 Series1 1 7 31 41 55 68 78 116 177 184 191 205 208 Recruitment (May–August) 64% of total n=208 of 328
  • 38. Current status •  64% of total (n=208 of 328) •  UK Service to commence ~October •  Recruitment estimated to conclude by December 2016 •  Baseline assessments for first patients now commencing
  • 39. Real-time Study Tracker (II) Planned Revisions: •  Include UK •  Update data for Poland •  Include baseline visit data
  • 40. Real-time Study Tracker (II) Planned Revisions: Colour-match trend lines with regional location indicators to help identify geographical origin of patients recruited to date
  • 41. ICS Cessation in COPD: ‘Real-Life WISDOM’ DIRKJE POSTMA & HELGO MAGNUSSEN FOR DISCUSSION FUNDING…?
  • 42. Background – ICS use in COPD •  Studies seeking to address whether combination ICS/LABA therapy improves COPD stability have traditionally concluded that withdrawal of ICS therapy is associated with:1–3 o  An increase in exacerbations and symptoms; o  Reduction in health-related quality of life o  An acceleration in lung function decline. •  Investigators have also concluded that ICS lack sustained disease-modifying effects after ICS cessation following a recent comparative study of lung function decline, AHR, and QOL over a 5-year follow-up period.4 1. Wouters EF, et al. Thorax. 2005;60:480-7; 2. Lapperre TS, et al. Ann Intern Med. 2009 Oct 20;151:517-27. 3. van der Valk P, et al. Am J Respir Crit Care Med. 2002;166:1358-63; 4. Kunz LI, et al. Chest. 2015;148:389-96.
  • 43. Background – WISDOM •  WISDOM evaluated the effect of gradual ICS withdrawal in COPD patients (n=2485) on triple therapy (ICS/tio/salmeterol) within an RCT environment and observed that: o  Exacerbation rates were similar in patients continuing versus discontinuing ICS therapy o  No significant differences in outcomes between ICS withdrawal and triple therapy patients across subgroups in which a greater degree of dependence on ICS might be expected o  No significant between group difference in the rate of dropout o  However… a greater decrease in lung function decline was observed in patients discontinuing ICS therapy in the final step of ICS withdrawal. 1. Magnussen H, et al. NEJM. 2014;371:1285-94.
  • 44. Study Concept •  The aim of the study is to evaluate the effect of ICS cessation (and reduced ICS exposure) on COPD lung function (and exacerbation rates) in patients with COPD managed in a routine care, “real-life” setting.
  • 45. Design: overview Using electronic primary care records data from the UK’s Optimum Patient Care Research Database (OPCRD), the study will include 2 x matched analysis. Index date Cohort A – Control Arm: continue on baseline therapy (no MPR restrictions) Baseline Patients on FDC ICS/LABA and separate LAMA ICS MPR ≥70% 1 year 1 year Annual exploratory endpoints to 5 years post index date Month -12 Month -6 Month 12 Month 13 Month ……………………………..60 Month 0 Month 3 Cohort A – Cessation Arm: LABA / LAMA therapy (any combination of fixed or separate inhaler devices) No ICS prescriptions fro ≥3 months (i.e. prior to month 3) ICS Cessation Cohort ICS Reduction Cohort Index date Cohort B – Control Arm: continue on baseline therapy (at no or <50% reduction in ICS dose) Baseline Patients on: ICS/LABA/LAMA (any fixed or free combinations) ICS MPR ≥70% 1 year 1 year Annual exploratory endpoints to 5 years post index date Month -12 Month -6 Month 12 Month 13 Month ……………………………..60 Month 0 Month 3 Cohort B – Reduction Arm (prescribed): continue on baseline therapy but with ICS prescribed at ≥50% reduced dose
  • 46. Outcome Period & Endpoints Outcome period: •  Primary: 1 year •  Exploratory: o  24 months; 36 months; 48 months, 60 months1 o  12-weeks (where evaluable) as used in WISDOM2 Primary endpoints •  Time to first acute COPD exacerbation Secondary endpoints •  Exacerbation rate •  Change in FEV1 •  Treatment stability (absence of exacerbations and no escalation in pharmacotherapy) •  COPD-related hospitalisations (rate and time to first) 1. Kunz LI, et al. Chest. 2015;148:389-96; 2. Magnussen H, et al. NEJM. 2014;371:1285-94;
  • 47. Interaction analyses The interaction between the follow patient / clinical features and the study outcomes will be explored where feasible: •  Baseline blood eosinophil level •  Baseline exacerbation rate •  Presence of atopy •  Smoking status (current vs ex-) •  Prescribed baseline ICS particle size (extra-fine vs non- extra-fine)
  • 48. Feasibility: OPCRD Patient #s COPD patients Number* COPD diagnosis ever 132,962 On Triple Therapy (≥1 prescription for ICS, LAMA and LABA in latest 12-month period) 25,987 On triple therapy and discontinue ICS (on prescription of ICS, LABA and LAMA in baseline with only LABA and LAMA in outcome (using any LABA/LAMA prescription as index date) 687 On triple therapy and discontinue ICS* with ≥1 FEV1 during baseline year and FEV1 reading in the 0-5 years following ICS cessation/reduction 356 *Numbers valid as of September 2015 and will be substantially higher by the time of extraction.
  • 49. MODERN EPIDEMIOLOGY OF ALPHA1- ANTITRYPSIN DEFICIENCY (AATD) IN THE UK JOAN SORIANO, RAVI MAHADEVA, MARC MIRAVITLLES AND RUPERT JONES FOR DISCUSSION FUNDING…?
  • 50. Background •  Emphysema in AATD results from an excess of neutrophil elastase in the lung, which destroys elastin and the elastase inhibitor AAT that protects against proteolytic degradation of elastin.1 •  Cigarette smoking and infection also increase elastase production in the lung, thus increasing lung degradation.1 •  AATD is considered a rare disease, but it is believed to be largely underdiagnosed2 •  3.4 million individuals in the world have an AATD genotype that leads to a deficiency of this protein2 •  Previous estimates of AATD prevalence in the UK are outdated; current prevalence of is unknown.3–7 •  Large UK databases (e.g. the CPRD and OPCRD) have been used to evaluate the prevalence of COPD and asthma within the UK; little work in AATD has been conducted.7 •  The National Institute for Health and Care Excellence in the UK is currently reconsidering and reviewing his AATD treatment and management recommendations8 1. Stoller JK, et al. Am J Respir Crit Care Med 2012; 185:246; 2. de Serres FJ, et al. Chest 2002;122:1818–1829; 3. Hutchison DC, et al. Clin Sci 1970;38:19P; 4. Cook PJ, et al. Ann Hum Genet 1975;38:275-87; 5. Hutchison DC, et al. Bull Eur Physiopathol Respir 1980;16 Suppl:315-9; 6. Hutchison DC. Lung 1990;168 Suppl:535-42; 7. Jones RJ, et al. LRM. 2014;2:267-76; 8. NICE. Proposed HTA Human alpha1-proteinase inhibitor for treating emphysema Draft scope (pre-referral); March 2016;
  • 51. Study Aim •  To determine the epidemiological trends (1990-2015) of Alpha1-antitrypsin deficiency (AATD) in the UK, and its natural history in the population: o  Size of the problem o  Prevalence o  Incidence o  Mortality from 1990 to 2015 •  To benchmark AATD with other respiratory and non-respiratory conditions
  • 52. Data sources •  A combined dataset of patients from two UK primary care databases (de-duped) will be used: o  Clinical Practice Research Database o  Optimum Patient Care Research Database (OPCRD) •  Subpopulation data links – where available: o  Rates of hospitalisations and day cases of treatment for AATD will be assessed in patients with linked Hospital Episode Statistics (HES) data o  Mortality rate and cause of death will be assessed in patients with linked Office of National Statistics (ONS) data
  • 53. Patient Population: inclusion criteria To be eligible for inclusion in the study, patients must meet the following criteria, for each population group: •  AATD Population: Physician-diagnosed AATD (presence of a AATD Read code, ever) •  COPD Population: Physician-diagnosed COPD (presence of a COPD Read code) and/or spirometry-defined COPD: post- bronchodilator FEV1/FVC<0.7 •  General Population: Healthy control individuals, or patients with non-severe morbidities randomly identified
  • 54. Outcomes Co-Primary endpoints (stratified by year) •  AATD Incidence •  AATD Prevalence •  AATD mortality rates. Secondary endpoints •  Respiratory exacerbations •  Oral steroids courses •  Inpatient hospitalisations for AATD o  Respiratory, liver, or other, as per HES statistics •  Day cases for AATD treatment •  Other clinical outcomes of particular interest include: o  Oxygen saturation, imaging, Charlson index, mMRC dyspnoea, … Subgroup of AATD patients with liver disease: •  Child-Pugh score
  • 55. But first… a pilot Data source: OPCRD only (no linked secondary or mortality data) Population: AATD diagnosis only (i.e. no matched comparisons) Exploratory patient number: 100 Co-Primary endpoints (stratified by year) •  AATD Incidence •  AATD Prevalence •  AATD mortality rates. Secondary endpoints •  Respiratory exacerbations •  Oral steroids courses •  Other clinical outcomes of particular interest include: o  Oxygen saturation, imaging, Charlson index, mMRC dyspnoea Cohort: AATD …1997 2000 2005 2010 2015 Case%1:"AATD,"Female."25"yrs,"Dx"in"2005;"exitus"in"2008" Case%2:"AATD,"Male"45"yrs.,"Dx"in"2010" Figure%1:"Study"Design"Diagram"(exploratory)"" (exploratory,"with"two"extreme"AATD"case"examples)"