Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis

BMJ Open Gastroenterol. 2022 Feb;9(1):e000853. doi: 10.1136/bmjgast-2021-000853.

Abstract

Objectives: 5-aminosalicylate (mesalazine; 5-ASA) is an established first-line treatment for mild-to-moderate ulcerative colitis (UC). This study aimed to model the benefits of optimising 5-ASA therapy.

Methods: A decision tree model followed 10 000 newly diagnosed patients with mild-to-moderately active UC through induction and 1 year of maintenance treatment. Optimised treatment (maximising dose of 5-ASA and use of combined oral and rectal therapy before treatment escalation) was compared with standard treatment (standard doses of 5-ASA without optimisation). Modelled data were derived from published meta-analyses. The primary outcomes were patient numbers achieving and maintaining remission, with an analysis of treatment costs for each strategy conducted as a secondary outcome (using UK reference costs).

Results: During induction, there was a 39% increase in patients achieving remission through the optimised pathway without requiring systemic steroids and/or biologics (6565 vs 4725 for standard). Potential steroidal/biological adverse events avoided included: seven venous thromboembolisms and eight serious infections. Out of the 6565 patients entering maintenance following successful induction on 5-ASA, there was a 21% reduction in relapses when optimised (1830 vs 2311 for standard). This translated into 297 patients avoiding further systemic steroids and 214 biologics. Optimisation led to an average net saving of £272 per patient entering the model for the induction and maintenance of remission over 1 year.

Conclusion: Modelling suggests that optimising 5-ASA therapy (both the inclusion of rectal 5-ASA into a combined oral and rectal regimen and maximisation of 5-ASA dose) has clinical and cost benefits that supports wider adoption in clinical practice.

Keywords: 5-aminosalicylic acid (5-asa); inflammatory bowel disease; ulcerative colitis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Biological Products* / therapeutic use
  • Colitis, Ulcerative* / chemically induced
  • Colitis, Ulcerative* / drug therapy
  • Humans
  • Mesalamine / adverse effects
  • Mesalamine / therapeutic use
  • Neoplasm Recurrence, Local / chemically induced
  • Neoplasm Recurrence, Local / drug therapy
  • Remission Induction
  • Sulfasalazine / adverse effects

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Biological Products
  • Sulfasalazine
  • Mesalamine