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.
|Journal||BMJ Open Gastroenterology|
|Publication status||Published - 2022 Feb 14|
Bibliographical noteFunding Information:
Competing interests EL has received research grants from Janssen, Pfizer, and Takeda; educational grants from AbbVie, Janssen, MSD and Takeda; speaker fees from AbbVie, Falk, Ferring, Hospira, Janssen, MSD, Pfizer, and Takeda; participated in advisory boards for AbbVie, Celgene, Ferring, Hospira, Janssen, MSD, Pfizer, Takeda, Galapagos, Gilead, Arena, Elli Lilly; consultant for AbbVie. KP is an employee of Ferring Pharmaceuticals. SAA has participated in advisory board for Ferring. JB has received honoraria, research grants or consulting fees from Abbvie, Janssen, Takeda, Pfizer, Ferring, Bristol Myers Squibb, Gilead, Tillott’s, Sandoz, Chiesi, Celltrion, Microba and Antara. JHC has received personal fees from Celltrion, Inc. Eisai Korea, Ferring Korea, IQVIA, Ferring, Janssen Korea, Shire Korea and Takeda Korea. AUD has received fees for participation in clinical trials, review activities, such as data monitoring boards, statistical analysis, end point committees from Falk, Abbvie, Janssen, Gilead and Pfizer; consultancy fees from Abbvie, MSD, Ferring, Roche/Genentech, Takeda, Vifor, Pharmacosmos, Boehringer-Ingelheim, Falk, Janssen, Pfizer, Sandoz/Hexal, BMS/ Celgene, Tillotts, Amgen and Fresenius Kabi; payment from lectures including service on speakers bureaus from Falk Foundation, Ferring, MSD, Abbvie, Vifor, Janssen, Pfizer, Tillotts, Takeda, Gilead/ Galapagos; payment for development of educational presentations from Tillotts and Ferring. FM has served as speaker and received honoraria from Abbvie, Biogen,
1Hepato-Gastroenterology and Digestive Oncology Department, University and Centre Hospitalier Univestitaire (CHU) Liège, Liège, Belgium 2Ferring International Center SA, Saint-Prex, Switzerland 3Gastroenterology Department, Rashid Hospital, Dubai, UAE 4Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia 5Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of) 6Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany 7Department of Biomedicine, Unit of Pharmacology and Therapeutics, University of Porto, Porto, Portugal 8Department of Gastroenterology, São João University Hospital, Porto, Portugal 9Colorectal Surgery Department, Instituto de Coloproctologia ICO Clinica Las Americas, Medellin, Colombia 10University Clinic for Internal Medicine, Johannes Kepler University, Linz, Austria 11Division of Gastroenterology, Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada 12Clinical Department of Internal Medicine and Gastroenterology with Inflammatory Bowel Disease Subdivision, The Central Clinical Hospital of the Ministry of the Interior Affairs and Administration, Warsaw, Poland 13Collegium Medicum, Jan Kochanowski University of Kielce, Kielce, Poland 14Violicom Medical Limited, Aldermaston, UK 15NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK Acknowledgements Writing support was provided by Violicom Medical Limited and was funded by Ferring Pharmaceuticals.
Funding This work was supported by Ferring Pharmaceuticals.
All Science Journal Classification (ASJC) codes