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Profile of patients with inflammatory bowel disease in conjunction with unmet needs and decision-making for choosing a new biologic therapy: a baseline analysis of the VEDOIBD-Study

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

We characterized the profile of Crohn’s disease (CD) or ulcerative colitis (UC) biologic-naïve patients (starting a new therapy with vedolizumab or TNFα-antagonists), their baseline disease activity predictors, and their perception of the quality of life (HRQoL).

Methods

The VEDOIBD-Study is a real-world study on the effectiveness of vedolizumab vs other biologics as induction and maintenance therapy for CD and UC. A total of 627 CD and 546 UC patients were enrolled from IBD-experienced centers across Germany. In both biologic-naïve vedolizumab (n=397) and anti-TNF (n=359) patients, CD and UC disease severity and HRQoL predictors were analyzed with logistic regression. The results were reported as odds ratio (OR) and 95% confidence interval (CI).

Results

When compared to biologic-naïve anti-TNF patients, a first biological therapy with vedolizumab was considered for older CD patients, with a less complicated though longer disease course, and with a history of comorbidities. No differences in (unmet) needs were observed among patients with UC. The presence of extra-intestinal manifestations in biologic-naïve anti-TNF patients with CD (OR (95% CI): 3.83 (1.69–8.68)) and, in both biologic-naïve groups of patients with UC, stool frequency (2.00 (1.25–3.19); 1.82 (1.10–3.02), respectively) and rectal bleeding (2.24 (1.20–4.18); 1.92 (1.19–3.11), respectively) emerged as the most important predictors of disease severity, which in turn were also significantly associated with a worse HRQoL.

Conclusion

This study highlights the existence of unmet medical needs of patients with CD or UC, for whom a new biological therapy is planned as part of the VEDOIBD-Study, which considerably impacts their HRQoL.

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Acknowledgements

The authors thank all the physicians and nursing staff of the Kompetenznetz Darmerkrankungen for the recruitment and care of the VEDOIBD-Study participants. We thank Sina Franzenburg and Maren Moser of the Kompetenznetz Darmerkrankungen in Kiel for the study coordination, and Dr. Michelle Rothaug for proofreading the manuscript.

We thank Takeda Pharma Vertrieb GmbH & Co. KG., Berlin, Germany, for the financial support of the VEDOIBD-Study. We also thank the German Inflammatory Bowel Diseases group (GISG) for its cooperation.

Funding

The VEDOIBD-Study was funded by Takeda Pharma Vertrieb GmbH & Co. KG., Berlin, Germany.

Author information

Authors and Affiliations

  1. Kompetenznetz Darmerkrankungen, Kiel, Germany

    Romina di Giuseppe, Sandra Plachta-Danielzik, Bernd Bokemeyer & Stefan Schreiber

  2. Gastroenterology Practice, Saarbrücken, Germany

    Wolfgang Mohl

  3. Gastroenterology Practice, Iserlohn, Germany

    Martin Hoffstadt

  4. Gastroenterology Practice, Kassel, Germany

    Thomas Krause

  5. Interdisciplinary Crohn Colitis Centre Minden, Märchenweg 17, 32439, Minden, Germany

    Bernd Bokemeyer

  6. Clinic of General Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Germany

    Bernd Bokemeyer & Stefan Schreiber

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  1. Romina di Giuseppe
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Contributions

Study design: BB, SS. Conception of the work: BB, RdG, SPD, SS. Patient recruitment and data collection: BB, MH, TK,WM, SPD, SS. Data management and statistical analysis: RdG. Data interpretation: BB, RdG, SPD, SS. Writing original draft: RdG, SPD. Critical revision of the manuscript: BB, RdG, MH, TK,WM, SPD, SS.

Corresponding author

Correspondence to Bernd Bokemeyer.

Ethics declarations

Ethics approval

Study procedures have been approved by the Ethics Committee of the Faculty of Medicine of Kiel University, Germany, (AZ D461/17) in compliance with the Professional Code of Conduct of the Schleswig-Holstein Chamber of Physicians and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Informed consent for publication was obtained from all individual participants included in the study.

Conflict of interest

RdG and SPD have no relevant financial or non-financial interests to disclose.

WM has received consulting fees from Abbvie, Amgen, Hexal, Janssen, Pfizer, Synformulas, and Takeda, outside the submitted work. Fees for lectures and further education from Abbvie, Alanta health service GmbH, Almirall, Aptalis, biogen, Falk, Gilead, Janssen, Pfizer, Medtronic, MSD, Shire, Takeda, and Vifor, outside the submitted work. Fees for studies from Abbvie, Janssen, MSD, Pfizer, and Takeda, outside the submitted work. Fees for activities in public law bodies as member of the Advisory Commission of the Examination Office for the Saarland, the State Committee of Physicians and Health Insurance Companies and the Extended State Committee, outside the submitted work. Dependent employment in the group of Alanta health group GmbH, Hamburg, outside the submitted work. Shares and other fees from Abbvie and Gilead, outside the submitted work.

MH has received fees for studies from Sandoz, Janssen, and Abbvie, outside the submitted work.

TK has received consulting fees from Takeda, Janssen, Pfizer, Ferring, AbbVie, and MSD, outside the submitted work.

BB has received consulting fees from AbbVie, MSD, Shire, Ferring, Hospira, Takeda, Movetis, Shield Therapeutics, Pfizer, Biogen, Janssen, Hexal, and Celgene, outside the submitted work. Financial support for lectures and teaching from AbbVie, Ferring, MSD, Merckle, Falk, HLR, Shield Therapeutics, Pfizer, Celltrion, Takeda, Janssen, and Mundipharma, outside the submitted work. Grant and financial support for research from AbbVie and Ferring, outside the submitted work.

SS has received personal fees from Abbvie, Arena, BMS, Biogen, Celltrion, Celgene, IMAB, Gilead, MSD, Mylan, Pfizer, Fresenius, Janssen, Takeda, Theravance, provention Bio, from Protagonist, and Falk, outside the submitted work.

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Romina di Giuseppe and Sandra Plachta-Danielzik contributed equally as first authors.

Bernd Bokemeyer and Stefan Schreiber contributed equally as last authors.

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di Giuseppe, R., Plachta-Danielzik, S., Mohl, W. et al. Profile of patients with inflammatory bowel disease in conjunction with unmet needs and decision-making for choosing a new biologic therapy: a baseline analysis of the VEDOIBD-Study. Int J Colorectal Dis 36, 2445–2453 (2021). https://doi.org/10.1007/s00384-021-03943-5

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