Benefit-Risk Trade-offs and Patient Preferences for Therapy Selection in Ulcerative Colitis: a Multicountry Preference Study.

benefit-risk assessment filgotinib ulcerative colitis

Journal

Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162

Informations de publication

Date de publication:
10 Aug 2024
Historique:
received: 05 03 2024
medline: 10 8 2024
pubmed: 10 8 2024
entrez: 10 8 2024
Statut: aheadofprint

Résumé

To help navigate the complex treatment landscape of ulcerative colitis (UC), we quantified the benefit-risk trade-offs that patients were willing to make when choosing treatment. Patients completed an online discrete choice experiment. Eligible patients had a UC diagnosis for ≥6 months, were aged ≥18 years, and resided in France, Germany, Italy, Spain, or the UK. Patients chose between 2 hypothetical treatments set up to ensure trade-offs were made. Clinical trial data, literature review, and patient interviews identified treatment attributes. Relative attribute importance (RAI) scores and maximum acceptable risks were generated. A patient-centric benefit-risk assessment of 200 mg of filgotinib was conducted as an example to show how measured trade-offs can be used. Overall, 631 patients participated; patients had a mean age of 42.2 years and were predominantly male (75.3%). Achieving and maintaining clinical remission was the most important factor for patients (RAI 32.4%); to achieve this, patients were willing to accept slightly higher risks of blood clots, serious infections, and malignancies compared with lower risk treatment profiles. Patients also valued the convenience of oral treatments, avoiding steroids, and the ability to attend school/work. The patient-centric benefit-risk assessment suggested patients are significantly more likely to prefer Janus kinase 1 preferential inhibitor filgotinib over placebo. Achieving clinical remission was the highest treatment priority for patients. To attain this, patients were willing to accept some slightly higher risk treatment profiles. Patient choices in the benefit-risk assessment suggested patients were significantly more likely to prefer filgotinib over placebo. Patients were willing to accept slightly higher risk treatment profiles over lower risk treatment profiles for an increased chance of achieving and maintaining remission. A patient-centric benefit-risk assessment suggested 200 mg of filgotinib had an acceptable benefit-risk profile.

Sections du résumé

BACKGROUND BACKGROUND
To help navigate the complex treatment landscape of ulcerative colitis (UC), we quantified the benefit-risk trade-offs that patients were willing to make when choosing treatment.
METHODS METHODS
Patients completed an online discrete choice experiment. Eligible patients had a UC diagnosis for ≥6 months, were aged ≥18 years, and resided in France, Germany, Italy, Spain, or the UK. Patients chose between 2 hypothetical treatments set up to ensure trade-offs were made. Clinical trial data, literature review, and patient interviews identified treatment attributes. Relative attribute importance (RAI) scores and maximum acceptable risks were generated. A patient-centric benefit-risk assessment of 200 mg of filgotinib was conducted as an example to show how measured trade-offs can be used.
RESULTS RESULTS
Overall, 631 patients participated; patients had a mean age of 42.2 years and were predominantly male (75.3%). Achieving and maintaining clinical remission was the most important factor for patients (RAI 32.4%); to achieve this, patients were willing to accept slightly higher risks of blood clots, serious infections, and malignancies compared with lower risk treatment profiles. Patients also valued the convenience of oral treatments, avoiding steroids, and the ability to attend school/work. The patient-centric benefit-risk assessment suggested patients are significantly more likely to prefer Janus kinase 1 preferential inhibitor filgotinib over placebo.
CONCLUSIONS CONCLUSIONS
Achieving clinical remission was the highest treatment priority for patients. To attain this, patients were willing to accept some slightly higher risk treatment profiles. Patient choices in the benefit-risk assessment suggested patients were significantly more likely to prefer filgotinib over placebo.
Patients were willing to accept slightly higher risk treatment profiles over lower risk treatment profiles for an increased chance of achieving and maintaining remission. A patient-centric benefit-risk assessment suggested 200 mg of filgotinib had an acceptable benefit-risk profile.

Autres résumés

Type: plain-language-summary (eng)
Patients were willing to accept slightly higher risk treatment profiles over lower risk treatment profiles for an increased chance of achieving and maintaining remission. A patient-centric benefit-risk assessment suggested 200 mg of filgotinib had an acceptable benefit-risk profile.

Identifiants

pubmed: 39126434
pii: 7731363
doi: 10.1093/ibd/izae162
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Gilead Sciences

Informations de copyright

© 2024 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.

Auteurs

Javier P Gisbert (JP)

Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Carlos III Health Institute, Madrid, Spain.

Stefan Schreiber (S)

Department of Internal Medicine I, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany.

Corey A Siegel (CA)

Inflammatory Bowel Disease Center, Section of Gastroenterology & Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.

Fernando Magro (F)

CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal.

Anna Jus (A)

Galapagos NV, Leiden, Netherlands.

Chiara Whichello (C)

Evidera Inc., London, UK.

Christine Michaels-Igbokwe (C)

Evidera Inc., Montreal, QC, Canada.

Sebastian Heidenreich (S)

Evidera Inc., London, UK.

Alessandra Oortwijn (A)

Galapagos NV, Leiden, Netherlands.

Séverine Vermeire (S)

Department of Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium.

Classifications MeSH