Current Projects

Inflammatory Bowel Disease

Real world effectiveness and safety of JAK inhibitors in ulcerative colitis: The Scot-Jak cohort

Project Lead: Nikolas Plevris

Method: Multi-centre retrospective cohort analysis of medical records

Cohort: Patients on JAKi (filgotinib and tofacitinib) for the treatment of UC

Inclusion criteria:

  1. Diagnosis of UC or IBDU favouring UC
  2. Symptoms attributed to active UC plus objective evidence of inflammation (CRP≥5, FC ≥250mcg/g, active inflammation on endoscopy / imaging)
  3. Minimum of 8-weeks follow up

Primary Outcome (week 8-12, week 26 and week 52):

  1. Rates of clinical remission (Partial Mayo <2 or SCCAI <5)

Secondary Outcomes (week 8-12, week 26 and week 52):

  1. Rates of biochemical remission (CRP <5 + FC <250mcg/g)
  2. Rates of mucosal healing (Endoscopic Mayo 0 or 1)
  3. Drug persistence
  4. IBD specific hospitalisation
  5. Colectomy rates
  6. Steroid use
  7. Rates of dose escalation (tofacitinib only)
  8. Safety and adverse events (inc. DVT, PE and malignancy)
  9. Predictors of effectiveness
  10. Comparative effectiveness between JAKi based on propensity score matching (if numbers allow)

Ethics: Caldicott approval will be required for data collection and dissemination. Scotland-wide approval will be applied for to avoid need for multiple site approvals.

Future work: The database can then be re-utilised for a second phase project to collect the same outcomes for upadacitinib which is now approved

Sponsored by The Scottish Society of Gastroenterology
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