Transcript PRED4-Newsletter-December-2013-modified-by-TA

Predicting Serious Drug Side Effects in Gastroenterology - PRED4
International IBD Genetics Consortium Projects
www.ibdresearch.co.uk/pred4
• Thank you all very much indeed for your fantastic support over 2013. We have recruited a total of 936 patients to PRED4,
which is a great achievement. We have until the end of 2013 to reach our initial target of 1100 patients.
• The Pharmacogenetics Office will be closed 24th December 2013 - 1st January 2014. You may still send samples over this
period as lab staff will be working over this period.
• If you have any urgent queries you may call our Research nurse Suzie Marriott on 01392 408937 or 07810 834996 between
Christmas and New Year’s Eve.
We are extending PRED4 until December 2014.
The thiopurine induced pancreatitis arm of the study is now closed and we have added 2 new arms (below) which will
open in January 2014.
Sulphasalazine Induced Neutropaenia
• History of inflammatory bowel disease or Rheumatoid arthritis
• History of Sulphasalazine exposure in the previous 30 days
• Normal total white cell count and neutrophil count at baseline
• Fall in neutrophil count to ≤0.5 x109/L
• Medical opinion implicating Sulphasalazine leads to dose reduction or drug withdrawal (even if temporary)
Thiopurine induced Liver Injury
• History of inflammatory bowel disease
• Normal ALT and bilirubin at baseline
• No pre-existing liver disease
• Elevation of ALT and/or bilirubin to ≥ 5 times upper limit of normal (defined by local lab)
• History of thiopurine exposure in the previous 30 days prior to this abnormal blood test
• Medical opinionTips
implicating
thiopurine
in development
of hepatotoxicity
which we
have found
helpful to identify
PPI and TNF patients
Talk to your Neurologists, Rheumatologists and Dermatologists (and Neurophysiology)
Contact imaging for MRI scans and cross check with codes for UC (K51) and CD (K50); Arthropathies (M00-M25) and
Spondyloarthropathies (M45-M49); G35-G37 (Demyelinating diseases of the CNS); or other conditions for which the
Anti-TNFα is being used.
Codes for identifying patients with PPI induced renal failure:
The NEXT Steps……
M13.1 (Percutaneous needle biopsy of lesion of kidney) + N10 and N12 (Acute tubulo-interstitial nephritis) OR
Y53 (Side
effectshappens
from Gastrointestinal
drugs)
We thought it would be an idea to share with
you what
to the blood
samples and case report forms when they
are
received
in
Exeter.
The
blood
samples
are
delivered
to
our
molecular
genetics
where
theRenal
DNAteam
is extracted
If you have clinic letters available in an electronic format, ask your IT department do a search laboratory
for patients seen
by the
with PPI /
and then stored until the genetic wide
association
studies
(GWAS)
are performed.
The case report forms are all
omeprazole
etc. in the
“Diagnosis”
or “Medical
History” sections.
‘adjudicated’ by an expert panel of consultants. The panel look at each case/patient to evaluate how likely it is that the
We have found that raising the profile of the Anti-TNF/ PPI study to our neurology and renal colleagues has also been very
drug caused the adverse event. The patients are graded as definite or probable or possible or unlikely cases of drug
successful. E.g. MDT meetings or at lunch time presentations. We can also provide you with laminated inclusion criteria to
induced serious adverse events. DNA from definite and probable cases are then sent for genotyping and analyses.
place in clinic rooms.
Marian Parkinson
Tel: 01392 403812
[email protected]
Clare Heard
Tel: 01392 403818
[email protected]
Dr Tariq Ahmad (Chief Investigator)
E-mail: [email protected]
Junior doctors:
Dr Abhey Singh (TNF)
[email protected] ;
Claire Bewshea –
IBD Research Project Manager
E-mail: [email protected]
Tel: 01392 406928
Mobile: 07828146468
Dr Graham Heap (TIP/TIM)
[email protected]
Dr Naomi Edney
[email protected] (PPI)
PRED4 Hospital sites - number recruited is based on the samples logged in laboratory by:
28th November 2013
Please note figures exclude any screening log failures or patients withdrawn
Guy's Hospital, London
53
Shrewsbury & Telford Hospital
5
Royal Devon & Exeter Hospital
50
St Vincent's Hospital, Melbourne, Australia
5
Southampton General Hospital
35
Weston General Hospital
5
Royal Derby Hospital
26
Basingstoke & North Hants Hospital
4
Florence, Italy
24
Darlington Memorial & Bishop Auckland Hospital
4
Royal Berkshire Hospital
24
Flinders Medical C entre, South Australia
4
Hull Royal Infirmary
23
Great Ormond Street Hospital - Paediatric
4
St James's University Hospital, Leeds
21
King's Mill Hospital, Nottinghamshire
4
University of Alberta, C anada
21
Raigmore Hospital, Inverness
4
Western General Hospital, Edinburgh
20
Royal Blackburn Hospital
4
Addenbrooke's, C ambridge
19
Scunthorpe General Hospital
4
Orebro University Hospital, Sweden
18
South Africa, Groote Schuur
4
Ninewells Hospital, Dundee
17
St Vincent's Hospital, Sydney, Australia
4
University Hospitals Bristol
17
Stoke Mandeville Hospital, Bucks
4
Fremantle Hospital, Australia
16
James C ook University Hospital, South Tees
4
Nottingham University Hospitals
16
Warrington Hospital
4
Kent & C anterbury Hospital
14
Aberdeen Royal Infirmary
3
Royal C ornwall Hospital
14
Basildon Hospital
3
University Hospital Padua, Italy
14
Bradford Royal Infirmary
3
Gloucester Royal Hospital
12
C olchester General Hospital
3
Aintree University Hospital
11
C ounty Hospital Hereford
3
Derriford Hospital, Plymouth
11
Glasgow Royal Infimary
3
Mater C linic, Brisbane, Australia
11
Liverpool Hospital, Australia
3
Royal London Barts Hospital
11
Nottingham C hildren's Hospital - Paediatric
3
York Teaching Hospital
11
Royal Free Hospital, London
3
New C ross Hospital, Wolverhampton
10
Royal Hallamshire Hospital, Sheffield
3
Salford Royal Hospital
10
Royal Liverpool & Broadgreen Hospital
3
Torbay Hospital
10
Sandwell Hospital, Birmingham
3
John Radcliffe Hospital, Oxford
9
University Hospital North Tees
3
King's C ollege Hospital, London
9
West Middlesex University Hospital
3
Poole Hospital
9
Worthing Hospital
3
St Mark's Hospital, Harrow
9
Alder Hey C hildren's Hospital - Paediatric
2
Watford General Hospital
9
C rosshouse Hospital, Ayrshire & Arran
2
Airedale General Hospital
8
Dorset C ounty Hospital
2
Mid Yorkshire NHS Trust
8
Harrogate District Hospital
2
Norfolk & Norwich Hospital
8
Kiel, Germany
2
Queen Elizabeth Hospital, Birmingham
8
Leicester General Hospital - Paediatric
2
Royal Victoria Infirmary, Newcastle
8
Luton and Dunstable Hospital
2
St George's Hospital, London
8
Mater Dei Hospital, Malta
2
University Hospital North Staffordshire
8
Milton Keynes Hospital
2
Wythenshawe Hospital
8
Pennine Trust, Manchester
2
Yorkhill C hildren's Hospital, Glasgow - Paediatric
8
Regional Hospital Viborg, Denmark
2
C helsea and Westminster Hospital
7
Sheffield C hildren's Hospital - Paediatric
2
Frimley Park Hospital
7
University Hospital of Ioannina, Greece
2
Haifa, Israel
7
Yeovil District Hospital
2
Mount Sinai, C anada
7
Epsom & St Helier University Hospitals
1
Musgrove Park Hospital, Taunton
7
Ipswich Hospital
1
Royal Sussex C ounty Hospital, Brighton
7
Leeds General Infirmary - Paediatric
1
University C ollege London Hospital
7
Manchester Royal Infirmary
1
Birmingham Heartlands Hospital
6
North C umbria University Hospitals
1
C alderdale Royal Hospital
6
Queen Elizabeth Hospital, London
1
C hesterfield Royal Hospital
6
Royal Hampshire C ounty Hospital
1
Llandough Hospital, C ardiff
6
Royal United Hospital, Bath
1
Royal Adelaide Hospital, Australia
6
Shaare Zedek Medical C entre, Israel
1
Royal Bournemouth General Hospital
6
Southmead Hospital, Bristol
1
Royal Brisbane & Women’s Hospital, Australia
6
University Hospital Lewisham
1
South Tyneside District Hospital
6
University Hospital of Wales
1
Dudley Group of Hospitals
5
Worcester Royal Infirmary
1
Freeman Hospital, Newcastle (RENAL)
5
Kettering Hospital
5
Forth Valley Royal Hospital
5
Princess Alexandra Hospital, Essex
5
Queen Alexandra Hospital, Portsmouth
5
Total UK Recruited:
Total International Recruited:
Grand Total:
777
159
936