REG Biomarkers Working Group Meeting 26/09/15
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Transcript of REG Biomarkers Working Group Meeting 26/09/15
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2015 ERS EVENTS
DATE: SATURDAY SEPTEMBER 25TH
VENUE: Wyndham Apollo Hotel, AmsterdamMEETING ROOM: BoardroomTIME: 15:00-17.30PM
CHAIR: Leif Bjermer, Respiratory Medicine and Allergology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden
REG BIOMARKERSWORKING GROUP
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Agenda
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Letter to the Editor / Editorial discussing differences between NICE & GINA statements on FeNO
Review on the role of eosinophils / inflammometry in airways disease
Publication Updates
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Editorial for Review…Perspective Article: discussing differences between NICE & GINA statements on FeNO (focus on inflammometry)
• Target journal: npj Primary Care Medicine (previously drafted for Respiratory Medicine; revised target JACI: In Practice but also discussed; Lancet Respiratory Medicine also suggested by Zuzana Diamant on Sept 24th)
• Next steps: Kjell Alving developing first draft (for review at ERS meeting)
• Motivated by new UK NICE Guidance: which:o Recommends FeNO (in addition to spirometry) in all patients to
help diagnose asthma. If obstruction is detected on spirometry, a responsiveness test will also be carried out.
o Does not recommend FeNO to help guide on-going management (due to limitations in the current evidence)
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Biomarker review paper• Working title: Inflammometry in obstructive airway disease – time for
a reappraisal
• Concept: A review of eosinophils/inflammometry in airways disease
• Rationale: o Mike Thomas received feedback on his EAACI talk (on blood
eosinophils as predictors of future risk in asthma and COPD) that suggested a lack of understanding of the potential value of blood eosinophils as a biomarker in primary care.
o There would be value in a review paper to discuss the potential utility of blood eosinophils for primary care respiratory medicine
o The review should focus on clinically accessible biomarkers and provide useful guidance to primary care clinicians
• Target journal: Nature Primary Care Respiratory Medicine
• Next steps: Editor has approved concept in theory; agree authorship at ERS ...
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OPCRD Data QueriesSpecific Ideas proposedExtension of OPC biomarker data collection
Future Study Ideas
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OPCRD Queries following Barcelona
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Research ideas prompted by the data
• FeNO as a predictor of ICS response in COPDo Helgo Magnussen
• FeNO as a predictor of COPD exacerbationso Bernardino Alcázar
• Others...?
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OPCRD FeNO data & expansion plans
• Study ideas relating to FeNO as a biomarker in COPD:o Immediately infeasible in OPCRD: ≤100 COPD patients with
FeNO data• Short-term: other datasets…?• Medium- / longer-term:
o iHARP in COPD– FeNO will be collected (and linked to routine records in
OPCRD)– Status: Service expansion proposal – Funding to be confirmed– Intentions to start to implement Q3 2015
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Additional OPCRD Biomarker updates
• The Optimum Patient Care Clinical Service will be integrating a new IgE point care test into the service (skin prick test that provides IgE reading) o Use in uncontrolled ≥Step 3 (primarily) ± those with
poor inhaler techniqueo Devices approved for use; anticipate implementation
Q1 2016• The OPC Research Database will contain
additional IgE data available for research shortly thereafter.
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Research ideas discussed in Barca (I)
1. Evaluate the utility of blood eosinophils as a predictor of outcomes:o Identify steroid naïve patients with a normal blood eosinophil counto Evaluate whether their outcomes are worse if they are treated (vs not treated) with
ICS
2. Elevated FeNO & Blood Eosinophils: Identify patients with both blood eosinophil data & FeNO data and evaluate whether presence of both (i) raised blood eos and (ii) raised FeNO are associated with increased exacerbation risko A similar study was previously carried out in the National Health and Nutrition
Examination Survey (NHANES) database. o Data from Uppsala suggest that, independently, neither raised FeNO nor raised
blood eosinophils is predictive, but when jointly / both are raised, the have a strong link with mortality.
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Research ideas discussed in Barca (II)
3. Utility of blood eosinophils as a predictor of response to therapy – dual bronchodilation vs ICS/LABA:o Compare outcomes for COPD patients who initiate treatment as ICS/LABA
therapy with those initiating LABA/LAMA therapyo Stratify the results by blood eosinophils counto LABA/LAMA patient numbers in the OPCRD are currently low – this may
need to be a future studyo There are currently sufficient numbers to compare outcomes for ICS/LABA
vs Triple therapy (stratified by blood eosinophil count) ahead to comparing ICS/LABA to dual bronchodilation, when numbers permit.– A protocol has already been drafted by REG for the ICS/LABA vs Triple
therapy in collaboration with Alberto Papi (study funding still to be found)
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Research ideas discussed in Barca (II)
4. Link between smoking and FeNO level: the NHANES database contains an objective marker of cigarette exposure (serum cotinine).
5. Consider pulmonary vs systemic drivers of high blood eosinophils, e.g.:o If FeNO decreases but blood eosinophil count does not, it may suggest the
presence of small airways disease and indicate a trial of extra-fine particle ICS. Alternatively high blood eosinophil (in those with low FeNO) may suggest the presence of another condition that is not being adequately managed.
o High blood eosinophils may be a marker of systemic risk – there are data to suggest that COPD patients with cardiovascular disease are at increased risk of mortality if treated with tiotropium rather than ICS/LABA. It is uncertain whether the risk is driven by systemic inflammation in general, or by systematic inflammation associated with COPD exacerbations.
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Research ideas discussed in Barca (II)6. Link between eosinopenia and increase risk of pneumonia: Price et al
suggest:o Any link is very weak and it is difficult to evaluate as pneumonia incidence
is very low.o Pneumonia incidence is dose related and pneumonia o Pneumonia incidence tends to be higher in patients using standard
particle ICS therapies rather than extra-fine particle ICS formulations – likely as a higher dose of standard particle ICS was required to achieve equivalent effects in the lungs.
7. Consider opportunities to use biomarkers in the upper airway: FeNO levels in the nose tend to be low in patients with obstruction as it is produced in the sinuses:o This could be a topic of future research interest o Action: identify the number of patients in the OPCRD with rhinitis who also
have FeNO data. – N=306
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Agree some seed projects… & date of next meeting
What’s next for the group…?