Multinational evaluation of clinical decision-making in the treatment and management of mild-to-moderate ulcerative colitis

Abstract

Objectives

To understand current thinking and clinical decision-making in the treatment and management of patients with mild-to-moderate ulcerative colitis (UC).

Methods

This multinational, survey-based study was conducted in 2021. Two meetings were held, involving 11 IBD specialists, that used a series of questions and discussion to identify all factors possibly related to the management of UC. The importance of identified factors was assessed using an online questionnaire covering three scenarios – active disease, remission and patient empowerment. Each factor was scored on a scale of 0 (very-unimportant) to 100 (very-important) within each scenario, by a separate group of healthcare professionals working in IBD.

Results

A total of 157 individual factors were identified by the 11 IBD specialists and scored in the three scenarios by 56 respondents (52; 93% specialist gastroenterologists) from Europe and North America (25; 45%), South America (19; 34%) and the Middle East, Asia and Australia (12; 21%). For all scenarios, factors related to educating patients regarding UC and its treatment and understanding of patient goals ranked highest, ahead of clinical considerations regarding disease activity and treatment history. Setting realistic short-term treatment targets was a key consideration. 5-ASA optimisation and use of faecal calprotectin monitoring were core strategies across the three scenarios tested. Support for patients during longer-term management of their disease, starting from initial flare, was an important recurring theme.

Conclusion

The current management approach for mild-to-moderate UC was found to be guided primarily by the patient’s perspectives and goals, alongside assessment of their medical and disease history.

Keywords:

• Induction
• maintenance
• remission
• 5-ASA
• optimisation
• mesalazine
• inflammatory bowel disease
• patient empowerment
• faecal calprotectin
• treatment goals

Disclosure statement

A. D. 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, Gilead, Galapagos, 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.

S. P. L. T. 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. K. P. is an employee of Ferring Pharmaceuticals. S. A. A. has participated in advisory board for Ferring. J. B. 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. J. H. C. has received personal fees from Celltrion Inc., Eisai Korea, Ferring Korea, IQVIA, Ferring, Janssen Korea, Shire Korea, and Takeda Korea. J. F. is an employee of Violicom Medical Limited that has received funding from Ferring for work on various projects. E. L. 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. F. M. 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. J. R. M. has received sponsorship as speaker from AbbVie, Biopas, Biotoscana, Farma, Ferring, Janssen, and Takeda. A. R. M. 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. N. N. has received grants, advisory board fees, or speakers bureau honoraria from Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Novartis, and Ferring. G. R. has received grants/research support or speakers fee from Abbvie, AlfaSigma, Astellas, Ferring, Janssen, Pfizer, Pharmabest, Recordatti, Sanprobi, Sandoz, Vitama and Takeda.

Data availability statement

All data supporting the findings of this study are available upon reasonable request to the corresponding author.

Additional information

Funding

This work was supported by Ferring Pharmaceuticals.