IBD in Patients with Moderate to Severe PSO

• Research type

  Research Study

• Full title

  Real-world pattern of Inflammatory Bowel Disease (IBD), raised faecal calprotectin and IBD red flag symptoms in Primary Care Patients with Moderate to Severe Psoriasis: a cohort study

• IRAS ID

  260046

• Contact name

  Richard Warren

• Contact email

  Richard.Warren@manchester.ac.uk

• Sponsor organisation

  North West EHealth

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 6 months, 9 days

• Research summary

  Inflammatory Bowel Disease (IBD) which includes both ulcerative colitis and crohns disease is common to other immune-mediated diseases, in particular, psoriasis. Previous studies have shown an increased risk of IBD in patients with psoriasis. However, a key limitation to these studies is they do not capture those who have symptoms or clinical characteristics indicative of IBD without a confirmed diagnosis, meaning they may underestimate the wider potential burden of IBD.
  Therefore, the aim of this epidemiological study is to identify patients with an existing diagnosis of IBD and patients with gut inflammation symptomatic of IBD, using faecal calprotectin (a marker of inflammatory bowel disease) and IBD red flags, in patients with moderate to severe psoriasis in a primary care setting.
  Patient’s will be defined as having moderate to severe psoriasis: as any patient with an existing diagnosis of psoriasis and any of the following documented in their medical records:
  1. Psoriasis Area and Severity Index (PASI) ≥10
  2. Referral to a dermatology specialist with a follow up appointment
  3. Received phototherapy or systemic therapy
  4. More than six treatment prescriptions in the last 12 months for psoriasis
  The study is a multi-centre study in the UK comprising of components; (1) a retrospective chart review, and in patients without a diagnosis of IBD (2) a stool sample to test for faecal calprotectin, (3) a bespoke patient questionnaire including the self- administered psoriasis area severity index (SAPASI)and (4) a follow up chart review 24 months following enrollment to the study

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  19/NW/0512

• Date of REC Opinion

  20 Aug 2019

• REC opinion

  Favourable Opinion