Predicting Serious Drug Side Effects in Gastroenterology - PRED4 International IBD Genetics Consortium Projects Welcome to the OCTOBER 2013 edition of the PRED4 newsletter IBD Research Team and how to contact us: Marian Parkinson - Tel: And Clare Heard - Tel: Tips which we have found helpful to identify 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: M13.1 (Percutaneous needle biopsy of lesion of kidney) + N10 and N12 (Acute tubulo-interstitial nephritis) OR Y53 (Side effects from Gastrointestinal drugs) If you have clinic letters available in an electronic format, ask your IT department do a search for patients seen by the Renal team with PPI / omeprazole etc in the “Diagnosis” or “Medical history” sections. We have found that raising the profile of the Anti-TNF/ PPI study to our neurology and renal colleagues has also been very successful. E.g. MDT meetings or at lunch time presentations. We can also provide you with laminated inclusion criteria to place in clinic rooms. Many thanks for recruiting to the PRED4 study, we are recruiting well but need an extra drive to recruit patients into the TNF and PPI arms of the study. The most successful way to increase recruitment is to involve your neurology, rheumatology and dermatology (TNF) and renal (PPI) consultants. Please see a reminder below of some of the tips to assist you with recruiting to the Anti-TNF and PPI arms. Thank you all very much for your efforts to date. The PRED4 study incorporates: TIP – Thiopurine induced Pancreatitis; TIM – Thiopurine induced myelosupression; PPI – PPI induced nephrotoxicity ; TNF – Anti- TNF induced demyelination Please can we ask you to send in your CRF forms as soon as possible. You may also use the eCRF for entering clinical data Please contact the team to obtain a user name. Thank you. Dr Tariq Ahmad (Chief Investigator) Claire Bewshea – IBD Research Project Manager Tel: Mobile: Junior doctors: Drs Abhey Singh (TNF) ; Graham Heap (TIP/TIM) Noami Edney

PRED4 Hospital sites - recruitment numbers taken from the date sample tested in laboratory - up to 3 rd Oct 2013 Royal Devon & Exeter Hospital53 Weston Area NHS Trust Hospital, Weston-S-Mare5 Guy's Hospital, London52 Aberdeen Royal Infirmary4 Southampton General Hospital35 Basingstoke & North Hants Hospital4 Royal Derby Hospital26 Darlington Memorial & Bishop Auckland Hospital4 Florence, Italy24 Great Ormond Street Hospital – Paediatric4 Hull Royal Infirmary, East Yorkshire24 Royal Blackburn Hospital East Lanc's4 Nottingham University Hospitals23 South Africa, Groote Schuur4 Royal Berkshire Hospital, Reading22 Stoke Mandeville Hospital, Bucks4 Western General Hospital, Edinburgh20 The James Cook University Hospital, South Tees4 Addenbrooke's Hospital, Cambridge18 Warrington Hospital, Warrington & Halton4 Orebro University Hospital, Sweden18 Basildon Hospital3 University Hospital Bristol17 Bradford Royal Infirmary3 Ninewells Hospital, Dundee16 Colchester General3 Royal Cornwall Hospital, Treliske15 County Hospital Hereford3 St James's University Hospital, Leeds15 Dudley Group of Hospitals3 Freemantle Hospital Australia13 Glasgow Royal Infirmary3 Kent & Canterbury Hospital, East Kent13 Nottingham Children's Hospital, NUH-Paediatric3 University Hospital Padua, Italy12 Royal Liverpool & Broadgreen3 Derriford Hospital, Plymouth11 Scunthorpe General Hospital3 Gloucester Hospitals NHS F/T11 University Hospital of North Tees3 Mater Clinic, South Brisbane, Australia11 West Middlesex University Hospital3 The Royal London Barts Health NHS Trust11 Alder Hey Children’s Hospital2 Torbay Hospital – South Devon Healthcare NHS F/T11 Cross House Hospital, Ayrshire & Arran, Scotland2 New Cross Hospital, Wolverhampton10 Dorset County Hospital2 Salford Royal Hospital, Manchester10 Harrogate & District NHS Foundation Trust2 St Mark's Hospital, Harrow10 Kiel, Germany2 York Teaching Hospital10 Luton & Dunstable Hospital2 John Radcliffe Hospital Oxford9 Mater Dei Hospital, Malta2 Kings College Hospital, London9 Milton Keynes Hospital, Buckinghamshire2 Watford General Hospital, West Herts9 Queen Alexandra Hospital, Portsmouth2 Aintree University Hospitals NHS Trust8 Regional Hospital Viborg, Denmark2 Airedale General Hospital, West Yorkshire8 Royal Hallamshire Hospital, Sheffield2 Mid Yorkshire NHS Trust8 Sandwell Hospital Birmingham2 Norfolk & Norwich Hospital8 Sheffield Children's Hospital – Paediatric2 Poole Hospital NHS F/Trust8 University Hospital of Ioannina, Greece2 St George's, Tooting, London8 Worthing Hospital, West Sussex2 University Hospital of North Staffordshire8 Epsom & St Hellier Hospital1 Yorkhill Children's Hospital, Glasgow – Paediatric8 Ipswich Hospital1 Haifa, Israel7 Leeds General Infirmary Hospital –Paediatric1 Mount Sinai, Toronto, Canada7 Leicester General Hospital – Paediatric1 Queen Elizabeth Hospital, Birmingham7 Lewisham University Hospital1 Royal Victoria Hospital, Newcastle7 Manchester Royal Infirmary1 Sussex County Hosp., Brighton University Hospital7 North Cumbria Hospital1 Calderdale Royal Hospital6 Royal Free Hospital, Hampstead1 Chesterfield Royal Hospital6 Royal Hampshire County Hospital1 Frimley Park Hospital, Surrey6 Royal United Hospital, Bath1 Llandough Hospital, Cardiff6 Sandwell Hospital Birmingham1 Musgrove Park Hospital, Taunton6 Shaare Zedek Medical Centre, Israel1 Royal Bournemouth General Hospital6 Southmead Hospital, North Bristol1 University College London Hospital6 St James's University Hospital, Leeds & Nott's Children's1 University Hospital (Wythenshawe) South Manchester6 University Hospital of Wales, Cardiff1 Birmingham Heartlands Hospital, Birmingham5 Worcester Royal Infirmary1 Chelsea & Westminster Hospital, London5 Freeman Hospital, Newcastle (RENAL)5 Kettering Hospital, Northampton5 Total from UK sites744 King's Mill Hospital, Nottinghamshire5 Total from International sites105 NHS Forth Valley Royal Hospital, Larbert, Scotland5 Princess Alexandra Hospital, Essex5PRED4 GRAND TOTAL RECRUITED849 Shrewsbury & Telford Hospital5 South Tyneside NHS Foundation Trust5