1. SEVERE ASTHMA /BIOMARKERS Joint WORKING GROUP MEETING
Co-chairs: Leif Bjermer & David Price
Administration: Optimum Patient Care (OPC)
DATE: Saturday 9th September 2017
TIME: 15.50
VENUE: Meliá Milano, Via Masaccio 19, Milan

2. Meeting attendees Arata Azuma Sajid Hansraj
Alvaro Cruz Victoria Carter
K F Chung Marcela Gavornikova
Fulvio Braido Sheri Rogers
Akio Niimi Dragos Bumbacea
Ulla Seppala Akio Niimi
Renaud Louis Kjell Alving
Danny McBryan David Price
Alberto Papi Richard Costello
Glenn Crater Leif Bjermer
Heather Hoch Therese Lapperre
Mohsen Sadatsafavi Heather Hoch
Pascal Pfis Lakmini Bulathsinhala

3. Agenda 15.50 -15.55 Welcome / Introduction Leif Bjermer & David Price
15.55 – 16.10: REG Projects 2017
Use of electronic medical records and biomarkers (published ECRJ 2017) David Price/Author present
NICE/GINA FENO letter to the Editor: Kjell Alving
OPC & OPRI Biomarker & Severe Asthma Projects David Price
16.10 –16.20 ISAR Initiative & Data Sources Update
International Severe Asthma Registry (ISAR) Lakmini Bulathantisia
Optimum Patient Care Research Database (OPCRD) Victoria Carter
16.20–16.40 New Projects & Initiatives
New Projects Discussion All

4. REG SEVERE ASTHMA /BIOMARKERS Projects : ERS 2017 Update

5. Use of electronic medical records and biomarkers to manage risk and resource efficiencies
Biomarkers used in isolation or combination are powerful composite metrics for predicting future risk.
Promise of greater clinical insight through combining FeNO and blood eosinophil values to generate a ‘composite inflammatory biomarker
An integrated EHR remains the ultimate goal, a ‘big data’ scenario - containing
standard clinical information,
new biomarker results, and
behavioural/contextual data from connected devices
M. Kerkhof1*, T. Tran2, M. van den Berge3, G. Brusselle4, G. Gopalan2, R. Jones5, J.
Kocks3, A. Menzies-Gow6, J. Nuevo2, I. Pavord7, S. Rastogi2, D. Price1

6. Use of electronic medical records and biomarkers to manage risk and resource efficiencies

7. GINA / NICE FeNO Editorial Update
Update from Kjell Alving – paper has been written but rejected from Lancet RM
Update on the formal NICE publication
Decision of next steps in regard to the paper
Kjell to rework for re-submission of this paper to ERJ
M. Kerkhof1*, T. Tran2, M. van den Berge3, G. Brusselle4, G. Gopalan2, R. Jones5, J.
Kocks3, A. Menzies-Gow6, J. Nuevo2, I. Pavord7, S. Rastogi2, D. Price1

8. Predictive value of FeNO in patients with non-specific respiratory symptoms: a randomised controlled trial
For every 10ppb increase in baseline FeNO, the improvement of ACQ was greater in the extrafine ICS arm compared to the placebo arm

9. Health care resource use and costs of severe, uncontrolled eosinophilic asthma in the UK general population
Less than 1% of patients in a UK general asthma population sample have SUEA

10. Rate Ratio of exacerbations
Assessing the Use of FeNO and blood eosinophils as biomarkers in predicting asthma exacerbations
Rate Ratio of exacerbations
Lower CI (95%)
Higher CI (95%)
High FeNO and low BEC (n=98)
1.35
0.99
1.84
High BEC and low FeNO (n=186)
1.41
0.91
2.19
High BEC AND high FeNO (n=53)
1.72
1.00
20.93
The presence of FeNO ≥35ppb and BEC ≥300/µL adds to the accuracy in identifying patients who are at risk of exacerbation, compared to the presence of FeNO or BEC alone.

11. International Severe Asthma Registry
Lakmini Bulathsinhala
9 September 2017

12. Live EDC System: CISIV
Core variables: User Acceptability Testing (UAT) phase (complete Sept )

13. Severe Asthma: Available Data Sources?
First year of ISAR (2017): over 1000 patients records
Expected start of data collection: Oct 2017
Data from the latest three years as of Dec 2017
OPCRD: a 3.4 million patient repository of routinely
collected primary care data in UK.
ISAR severe asthma patients’ primary care data linked to secondary care data
benchmark analyses

14. ISAR SC : 2017 Research Prioritisation
Research Topic
Rank
Feasibility
Demographic, clinical characteristics, comorbidities, medical management of Severe Asthma patients worldwide 1
Yes
Predictors of biologic response failure 2
Yes, Limited*
Biologics progressing patient proportion 3 No
Late versus early onset of Severe Asthma 4
Adherence (Quality use of therapy) 5
Quality of Life in Severe Asthma 6
Overlap in collected Biomarkers 7
Economic Burden of Severe Asthma 8
Asthma in young adults 9
Asthma in elderly 10
Characteristics of Asthma & COPD Overlap Syndrome in patients with severe asthma 11
Incidence of hidden severe asthma patients in primary care 12
* Variables not in core list or low sample size expected in 2017

15. Global Research Project: Timeline
2018
2017

16. ISAR Website and Publicity
ISAR website: portal to raise awareness and passive recruitment
Has been launched live in lieu of the ISC Meeting

17. Optimum Patient Care Research Database
Victoria Carter
9 September 2017

18. OPCRD Biomarkers Data Category All Patients Number of records
Asthma Patients
COPD Patients
Total
3,924,855
1,082,143,922 (Clinical) ,073,163(therapy)
798,546
152,788
Asthma Dx. (QoF)
3,527,324
46,750
COPD Dx. (QoF)
1,061,308
Rhinitis Dx
560,888
1,266,952
215,376
18,788
C reactive protein
655,264
1,929,812
152,335
47,550
Eosinophil Reading
2,131,253
13,060,575
474,294
126,916
FeNO
994(routine)+ 1156(clinical data)
1289(routine) (clinical data)
789(routine) (clinical data) 56
FeNO and Eosinophil reading
766
5,803
603 55
Neutrophil
1,586,976
8,538,834
322,151
86,197
Vitamin D level
54,291
139,283
12,805
3,526

19. New Project Ideas / Group Discussion

20. Previous Study Ideas from the Working Group…
Evaluate the utility of blood eosinophils as a predictor of outcomes
Utility of blood eosinophils as a predictor of response to therapy – dual bronchodilation vs ICS/LABA
Link between smoking and FENO level
Consider pulmonary vs systemic drivers of high blood eosinophils
Link between eosinophenia and increase risk of pneumonia
Consider opportunities to use biomarkers in the upper airway
Incidence of hidden severe asthma patients in primary care
M. Kerkhof1*, T. Tran2, M. van den Berge3, G. Brusselle4, G. Gopalan2, R. Jones5, J.
Kocks3, A. Menzies-Gow6, J. Nuevo2, I. Pavord7, S. Rastogi2, D. Price1