Clinical profiles and outcomes in patients with ulcerative colitis receiving standard and higher-than-standard doses of vedolizumab: findings from a real-world study in Europe

Abstract

Objective

Vedolizumab is an antibody targeting α₄β₇ integrin used in the treatment of ulcerative colitis (UC). Patients are commonly prescribed higher-than-standard doses if treatment response is inadequate, but little is known about the drivers and impact of increased dosing. Our objective was to use real-world data to describe vedolizumab dosages in current clinical practice, patient characteristics, physicians’ reasons for prescribing vedolizumab, and physician treatment satisfaction.

Methods

Data were derived from the Adelphi Real World UC vedolizumab Chart Review, a cross-sectional survey of gastroenterologists and their UC patients, conducted in France, Germany, Italy, Spain, and the United Kingdom between December 2022 and March 2023. Gastroenterologists provided data on patient demographics, clinical characteristics, treatment and vedolizumab dosage history, reasons for dose choice, and treatment satisfaction.

Results

Data were returned on 448 patients by 112 gastroenterologists. Overall, 83.5% of patients were on a standard vedolizumab dose and 10.3% were on a higher-than-standard dose. The worsening of symptoms was the most cited reason for higher doses. Most reported symptoms at survey were fatigue, abdominal distention or pain, diarrhea, and bowel urgency, with the latter particularly in higher-than-standard dose patients. Patients on higher-than-standard dose had high rates of mild (37.0%) or moderate (26.1%) disease, and low rates of remission (33.8%). Physicians were dissatisfied with treatment control for 2.7% of standard and 26.1% of higher-than-standard dose patients.

Conclusions

Over 10% of patients were receiving a higher-than-standard dose of vedolizumab, but despite this were found to have suboptimal clinical outcomes and low physician satisfaction.

Keywords:

• Ulcerative colitis
• vedolizumab
• treatment outcome
• observation
• administration and dosage

Transparency

Declaration of funding

Data collection was undertaken by Adelphi Real World as part of an independent survey, entitled the Adelphi Real World UC vedolizumab Chart Review. The Adelphi Real World UC vedolizumab Chart Review is a wholly owned Adelphi product. Eli Lilly and Company subscribed to this survey and did not influence the original survey through contribution to the design of questionnaires or data collection. Publication of study results was not contingent on the subscriber’s approval or censorship of the manuscript.

Declaration of financial/other relationships

PS, IR, SH and THG are employees of Eli Lilly and Company and may hold stock or stock options.

HK, EQ, NH, and VP are employees of Adelphi Real World.

JPG has served as a speaker, a consultant and advisory member for or has received research funding from MSD, Abbvie, Hospira, Pfizer, Kern Pharma, Biogen, Takeda, Janssen, Roche, Sandoz, Celgene, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma.

A reviewer on this manuscript has disclosed that they sit or have sat on the advisory board for and/or received lecture grants from AbbVie, Biogen, MSD, Galapagos, Ferring, Janssen, Pfizer, Takeda. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work but have no other relevant financial relationships to disclose.

Author contributions

All authors (1) were involved in conception or design, or analysis and interpretation of data; (2) were involved in drafting and revising the article; (3) reviewed and agreed on the final version to be published; and (4) agreed to take responsibility and be held accountable for the contents of the article, including resolving any questions raised about the accuracy or integrity of the published work.

Acknowledgements

Medical writing support under the guidance of the authors was provided by Niels Haan of Adelphi Real World, in accordance with Good Publication Practice (GPP3) guidelines.

Data availability statement

All data, i.e. methodology, materials, data, and data analysis, that support the findings of this survey are the intellectual property of Adelphi Real World. All requests for access should be addressed directly to Hannah Knight at [email protected]. Hannah Knight is an employee of Adelphi Real World.