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

Autores da FMUP

• Fernando José Magro Dias

  Autor

Participantes de fora da FMUP

• Louis, E
• Paridaens, K
• Al Awadhi, S
• Begun, J
• Cheon, JH
• Dignass, AU
• Márquez, JR
• Moschen, AR
• Narula, N
• Rydzewska, G
• Freddi, MJ
• Travis, SP

Unidades de investigação

• Biomedicina

• Laboratório Associado RISE- Rede de Investigação em Saúde

  

  Investigador

  Fernando Carlos De Landér Schmitt

• RISE-Health

  

  Investigador

  Fernando Carlos De Landér Schmitt

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 10000 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 pound 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

• FECAL CALPROTECTIN; ORAL MESALAZINE; MAINTENANCE; MANAGEMENT; INFLIXIMAB; RELAPSE; RISK