1. Predicting Serious Drug Side Effects in Gastroenterology - PRED4 International IBD Genetics Consortium Projects www.ibdresearch.co.uk/pred4 PRED4 newsletter November 2013 IBD Research Team and how to contact us: Marian Parkinson - Tel: 01392 403812 marian.parkinson@nhs.net And Clare Heard - Tel: 01392 403818 clare.heard@nhs.net Tips 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: 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. Dates to note 1.Thiopurine induced pancreatitis (TIP)– recruitment to this arm ends 31 December 2013. Please send in your final cases, CRFs and DCFs now! 2.Recruitment to all other arms will continue to the end of 2014 3.Sulphasalazine induced agranulocytosis (SIA) and Thiopurine induced liver injury (TILI) open from Jan 2014 (study amendment to include these additional arms within PRED4 to follow). Inclusion Criteria for new study arms (opening January 2014) – please start looking out for potential participants Sulphasalazine Induced Neutropaenia History of inflammatory bowel disease or Rheumatoid arthritis History of Sulphasalazine exposure in the previous 30days 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 opinion implicating thiopurine in development of hepatotoxicity Dr Tariq Ahmad (Chief Investigator) E-mail: tariq.ahmad1@nhs.nettariq.ahmad1@nhs.net Claire Bewshea – IBD Research Project Manager E-mail: claire.bewshea@nhs.net Tel: 01392 406928 Mobile: 07828146468 Junior doctors: Drs Abhey Singh (TNF) abhey.singh@nhs.net ; abhey.singh@nhs.net Graham Heap (TIP/TIM) grahamheap@nhs.net Naomi Edney naomi.edney@nhs.net (PPI)naomi.edney@nhs.net

2. PRED4 Hospital sites - number recruited is based on the samples logged in laboratory by:- 28th October 2013 Please note figures exclude any screening log failures or patients withdrawn Guy's Hospital, London52South Tyneside NHS Foundation Trust5 Royal Devon & Exeter Hospital50Weston Area NHS Trust Hospital, Weston-S-Mare5 Southampton General Hospital35Aberdeen Royal Infirmary4 Hull Royal Infirmary, East Yorkshire25Basingstoke & North Hants Hospital4 Royal Derby Hospital25Darlington Memorial & Bishop Auckland Hospital4 Florence, Italy24Great Ormond Street Hospital - Paediatric4 Royal Berkshire Hospital, Reading23King's Mill Hospital, Nottinghamshire4 Western General Hospital, Edinburgh20Royal Blackburn Hospital East Lanc's4 Addenbrooke's Hospital, Cambridge19South Africa, Groote Schuur4 Ninewells Hospital, Dundee18Stoke Mandeville Hospital, Bucks4 St James's University Hospital, Leeds18The James Cook University Hospital, South Tees4 Orebro University Hospital, Sweden17Warrington Hospital, Warrington & Halton NHS4 University Hospital Bristol17Basildon Hospital3 Nottingham University Hospitals16Bradford Royal Infirmary3 Kent & Canterbury Hospital, East Kent14Colchester General3 Royal Cornwall Hospital, Treliske14County Hospital Hereford3 Freemantle Hospital Australia13Dudley Group of Hospitals3 University Hospital Padua, Italy13Glasgow Royal Infirmary3 Derriford Hospital, Plymouth11Nottingham Children's Hospital, NUH -Paediatric3 Gloucester Hospitals NHS F/Trust11Royal Hallamshire Hospital, Sheffield3 Mater Clinic, South Brisbane, Australia11Royal Liverpool & Broadgreen3 The Royal London Barts Health NHS Trust11Sandwell Hospital Birmingham3 Torbay Hospital - SDHFT11Scunthorpe General Hospital3 New Cross Hospital, Wolverhampton10University Hospital of North Tees3 Salford Royal Hospital10West Middlesex University Hospital3 York Teaching Hospital10Alder Hey Hospital2 John Radcliffe Hospital Oxford9Crosshouse Hospital, Ayrshire & Arran, Scotland2 Kings College Hospital, London9Dorset County Hospital2 Poole Hospital NHS F/Trust9Harrogate & District NHS Foundation Trust2 St Mark's Hospital, Harrow9Kiel, Germany2 Watford General Hospital, West Herts9Luton & Dunstable Hospital2 Aintree University Hospitals NHS Trust8Mater Dei Hospital, Malta2 Airedale General Hospital, West Yorkshire8Milton Keynes Hospital, Buckinghamshire2 Mid Yorkshire NHS Trust8Queen Alexandra Hospital, Portsmouth2 Norfolk & Norwich Hospital8Regional Hospital Viborg, Denmark2 Royal Victoria Infirmary, Newcastle8Royal Free Hospital, Hampstead2 St George's, Tooting, London8Sheffield Children's Hospital - Paediatric2 University Hospital of North Staffordshire8University Hospital of Ioannina, Greece2 Yorkhill Children's Hospital, Glasgow - Paediatric8Worthing Hospital, West Sussex2 Frimley Park Hospital, Surrey7Epsom & St Hellier Hospital1 Haifa, Israel7Ipswich Hospital1 Mount Sinai, Toronto, Canada7Leeds General Infirmary Hospital - Paediatric1 Musgrove Park Hospital, Taunton7Leicester General Hospital - Paediatric1 Queen Elizabeth Hospital, Birmingham7Manchester Royal Infirmary1 Sussex County Hospital, Brighton7North Cumbria Hospital1 Wythenshawe Hospital, Manchester7Queen Elizabeth Hospital, South London1 Birmingham Heartlands Hospital6Royal Hampshire County Hospital1 Calderdale Royal Hospital6Royal United Hospital, Bath1 Chelsea & Westminster Hospital, London6Shaare Zedek Medical Centre, Israel1 Chesterfield Royal Hospital6Southmead Hospital, North Bristol1 Llandough Hospital, Cardiff6University Hospital Lewisham1 Royal Bournemouth General Hospital6University Hospital of Wales, Cardiff1 University College London Hospital6Worcester Royal Infirmary1 Freeman Hospital, Newcastle (RENAL)5Yeovil District Hospital1 Kettering Hospital, Northampton5 NHS Forth Valley Royal Hospital, Larbert, Scotland5 Total UK recruited:- 745 Princess Alexandra Hospital, Essex5 Total International:- 105 Shrewsbury & Telford Hospital5 Grand total :-850