Embedding research in UK IBD

services
Dr John Mansfield
Newcastle upon Tyne
 Presenter Declarations

This presenter has the following declarations of

relationship with industry:
• Honoraria / support from: Janssen, Falk and
Tillotts
• Research grants from Genentech/Roche
 Research on the Patient’s Journey
1. Diagnosis – Susceptibility environment genes
2. Initial treatment - Prognosis
3. Maintenance treatment of remission
4. On-going symptoms – Fatigue - pain
5. Side effects of treatment
6. Experimental treatment – ASUC – Stem cell Tx -
FMT – Commercial drug trials
7. Stopping treatment
8. Colon cancer risk
 Patient’s Journey
• Diagnosis – Susceptibility environment genes
• Initial treatment - Prognosis
• Maintenance treatment of remission
• On-going symptoms – Fatigue - pain
• Side effects of treatment
• Experimental treatment – ASUC – Stem cell Tx
- FMT – Commercial drug trials
• Stopping treatment
• Colon cancer risk
A programme for managing fatigue, pain
and urgency/ incontinence in IBD:
IBD BOOST

NIHR Programme grant, £2.3m over 5 years

Prof Christine Norton

Florence Nightingale Professor of
Clinical Nursing Research
King’s College
London
 IBD BOOST: Outline
• Qualitative (focus groups): patient priorities
• Co-design online self management programme: pilot
• Cohort study: symptoms, associations, clusters and
desire for help (12,500 people, 15+ centres)
– Checklist and Algorithm for IBD nurses to detect reversible
causes (including disease activity) for symptoms: treat and
reassess: 1000+ people
• Randomised Trial: online self management package +
IBD nurse specialist support vs. care as usual: 600 pt
• Health Economics and process evaluation

6
 Patient’s Journey
• Diagnosis – Susceptibility environment genes
• Initial treatment - Prognosis
• Maintenance treatment of remission
• On-going symptoms – Fatigue - pain
• Side effects of treatment
• Experimental treatment – ASUC – Stem cell Tx
- FMT – Commercial drug trials
• Stopping treatment
• Colon cancer risk
 I-CARE STUDY
Ibd CAncer and seRious infections in Europe

10826 patients have been enrolled by 485 investigators to date.

2468 patients in UK

ICARE in UK
PRED4: UK IBD Pharmacogenetics Network
 Patient’s Journey
• Diagnosis – Susceptibility environment genes
• Initial treatment - Prognosis
• Maintenance treatment of remission
• On-going symptoms – Fatigue - pain
• Side effects of treatment
• Experimental treatment – ASUC – Stem cell Tx
- FMT – Commercial drug trials
• Stopping treatment
• Colon cancer risk
 I ASO

Does giving anakinra alongside steroids

improve outcomes in Acute Severe UC?

A phase II randomised placebo controlled double blinded

trial of Interleukin 1 blockade in Acute Severe COlitis

11
 Autologous Stem Cell Transplantation in Crohn’s
disease: low intensity therapy evaluation
NIHR funded

James Lindsay
Professor of Inflammatory Bowel Disease
Barts and The London School of Medicine
Queen Mary University of London
Consultant Gastroenterologist, Barts Health NHS Trust
Blizard Institute
www.blizard.qmul.ac.uk
 STOP-COLITIS
A double blind randomised controlled trial to
investigate the efficacy of FMT in achieving and
maintaining remission in patients with UC

• 1 year 30 patient pilot comparing giving FMT through the

stomach or the bowel

• 230 patient trial with an efficacy endpoint

 Research on the Patient’s Journey
1. Diagnosis – Susceptibility environment genes
2. Initial treatment - Prognosis
3. Maintenance treatment of remission
4. On-going symptoms – Fatigue - pain
5. Side effects of treatment
6. Experimental treatment – ASUC – Stem cell Tx -
FMT – Commercial drug trials
7. Stopping treatment –SPARE
8. Colon cancer risk – ENDCaP-C
 Practical tips for research in IBD clinics

• Involve the whole team

– Colleagues
– IBD nurses
– Clinic nurses
– Infusion unit nurses
– Secretaries
– Patients – Patient groups etc
 More tips!
• Have research nurses attend IBD clinic
• Have the summary of open trials in every
clinic room
• Have the PIS (pt info sheets) in clinic
• If patients wait, use this time to prime them
about research – Banners / posters etc
• Only do trials you care about
 Conclusions
• IBD research in UK is very active

• Any IBD unit in the UK can participate in these

studies
– Investigators meeting Nottingham 12.11.18
– Keep a look out on BSG website for details

• The ambition: every IBD patient in every IBD

clinic to be offered an opportunity to participate
in research