Registry projects: Anaemia

Service Evaluation and the VEST

study
Fraser Cummings
Clinical lead UK IBD Registry

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Anaemia Service Evaluation

Joint Working Agreement model- Pharmacosmos
Objectives
1. Observe proportion of 100 IBD patients who have
IDA of ID
2. What treatment they receive
3. Quantify iron dosing and iron deficit
4. Assess Patient PROM in relationship to treatment
5. Potentially inform future audit

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Anaemia Service Evaluation

Management of iron deficiency in IBD
patients in 5 hospitals in the UK
10 consecutive UC and 10 CD outpatients
1 year follow up of patient

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Anaemia Service Evaluation

Patient phenotype
Medication history
IBD Control PROM
Disease activity score
Routine blood test results at 2 time points
1 year apart

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VEST: The UKVedolizumab real life experience

studyin inflammatorybowel disease
Dr Peter Irving1 Dr Keith Bodger and Dr Fraser Cummings2
Summary
Thisproject aimsto capture dataon the real life experience of the introduction
of vedolizumab to routine care of IBDpatients in the UKusingthe national IBD
registry.

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How to deliver it?

Modified UK IBD Registry Web Tool
Data entry costs (Band 6 nurse 6 hours
per patient)
Registry IG structure
Patients: study specific consent
NIHR Portfolio

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Primary Outcomes
The primary outcome will be steroid-free remission at one year as
defined by an HBI at week 56 of 4 or a UCDAI 2.
Secondary Outcomes
Secondary outcomes will include but not be limited to:
Remission and response rates at Week 6, 14, Week 30 and Week 54
Durable remission / response ie at week 14, 30 and 54
Effect of vedolizumab on disease activity as measured by the PRO2,
IBD control PROM, Physicians Global Assessment and biomarkers of
disease activity
Health care usage at 1 year using HES data (to be confirmed)
Tolerance and safety of vedolizumab at 1 year
Description of the demographics, disease phenotype, disease and
treatment history and concomitant medication use of patients receiving
vedolizumab
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 SB2/Flixabi (Samsung/Biogen)
Submitted as part of RMP to EMA

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Conclusions
Flexible platform for delivering investigator
initiated multi centre research
Piloting of IBD audit topics
Joint working models
Pharmacovigilance

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