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Inflammatory bowel disease
Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis
  1. Edouard Louis1,
  2. Kristine Paridaens2,
  3. Sameer Al Awadhi3,
  4. Jakob Begun4,
  5. Jae Hee Cheon5,
  6. Axel U Dignass6,
  7. Fernando Magro7,8,
  8. Juan Ricardo Márquez9,
  9. Alexander R Moschen10,
  10. Neeraj Narula11,
  11. Grazyna Rydzewska12,13,
  12. Matthew J Freddi14,
  13. Simon PL Travis15
  1. 1Hepato-Gastroenterology and Digestive Oncology Department, University and Centre Hospitalier Univestitaire (CHU) Liège, Liège, Belgium
  2. 2Ferring International Center SA, Saint-Prex, Switzerland
  3. 3Gastroenterology Department, Rashid Hospital, Dubai, UAE
  4. 4Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
  5. 5Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
  6. 6Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany
  7. 7Department of Biomedicine, Unit of Pharmacology and Therapeutics, University of Porto, Porto, Portugal
  8. 8Department of Gastroenterology, São João University Hospital, Porto, Portugal
  9. 9Colorectal Surgery Department, Instituto de Coloproctologia ICO Clinica Las Americas, Medellin, Colombia
  10. 10University Clinic for Internal Medicine, Johannes Kepler University, Linz, Austria
  11. 11Division of Gastroenterology, Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
  12. 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
  13. 13Collegium Medicum, Jan Kochanowski University of Kielce, Kielce, Poland
  14. 14Violicom Medical Limited, Aldermaston, UK
  15. 15NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK
  1. Correspondence to Dr Kristine Paridaens; kristine.paridaens{at}ferring.com

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.

  • ulcerative colitis
  • 5-aminosalicylic acid (5-asa)
  • inflammatory bowel disease

Data availability statement

All data supporting the findings of this study are available within the article or online supplemental information and no additional source data are required.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjgast-2021-000853

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    Data availability statement

    All data supporting the findings of this study are available within the article or online supplemental information and no additional source data are required.

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    Footnotes

    • Contributors All authors were responsible for conceptualisation, methodology, investigation, formal analysis, writing, manuscript review. All authors approved the final manuscript. MJF is the guarantor for this work.

    • Funding This work was supported by Ferring Pharmaceuticals.

    • 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, Bristol-Myers Squibb, Falk, Ferring, Hospira, Janssen, Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp & Dohme, Sandoz, Takeda, UCB and Vifor. JRM has received sponsorship as speaker from AbbVie, Biopas, Biotoscana, Farma, Ferring, Janssen, and Takeda. ARM is receiving research support from AbbVie and Takeda under the framework of the Christian Doppler Research Society; has received further consultation fees and/or speaker honoraria from AbbVie, Merck Sharp & Dohme, Takeda, Janssen-Cilag, Amgen, Sandoz, Nestlé, Ferring, Falk, and Pfizer. NN has received grants, advisory board fees, or speakers bureau honoraria from Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Novartis, and Ferring. GR has received grants/research support or speakers fee from Abbvie, AlfaSigma, Astellas, Ferring, Janssen, Pfizer, Pharmabest, Recordatti, Sanprobi, Sandoz, Vitama and Takeda. MJF is an employee of Violicom Medical Limited that has received funding from Ferring for work on various projects. SPLT has received Grants/Research Support from: AbbVie, Buhlmann, Celgene, IOIBD, Janssen, Lilly, Pfizer, Takeda, UCB, Vifor, and Norman Collisson Foundation; Consulting Fees from: Abacus; AbbVie; Actial; ai4gi; Alcimed; Allergan; Amgen; Aptel; Arena; Asahi; Aspen; Astellas; Atlantic; AstraZeneca; Barco; Biocare; Biogen; BLPharma; Boehringer Ingelheim; BMS; Buhlmann; Calcico; Celgene; Cellerix; Cerimon; ChemoCentryx; Chiesi; CisBio; ComCast; Coronado; Cosmo; Ducentis; Dynavax; Elan; Enterome; Equillium; Falk; Ferring; FPRT Bio; Galapagos; Genentech/Roche; Genzyme; Gilead; Glenmark; Grunenthal; GSK; GW Pharmaceuticals; Immunocore; Immunometabolism; Indigo; Janssen; Lexicon; Lilly; Medarex; Medtrix; Merck; Merrimack; Millenium; Neovacs; Novartis; Novo Nordisk; NPS-Nycomed; Ocera; Optima; Origin; Otsuka; Palau; Pentax; Pfizer; Pharmaventure; Phillips; P&G; Pronota; Proximagen; Resolute; Robarts; Sandoz; Santarus; Satisfai; Sensyne; Shire; SigmoidPharma; Sorriso; Souffinez; Syndermix; Synthon; Takeda; Theravance; Tigenix; Tillotts; Topivert; Trino Therapeutics with Wellcome Trust; TxCell; UCB Pharma; Vertex; VHsquared; Vifor; Warner Chilcott and Zeria; Speaker Fees from: AbbVie, Amgen, Biogen, Falk; Ferring, Janssen, Pfizer, Shire, Takeda, UCB; ST holds no stocks or share options.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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