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Transition from intravenous to subcutaneous biological therapies in inflammatory bowel disease: An online survey of patients

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Abstract

Background

The transition from in-hospital intravenous administration to subcutaneous therapies to treat inflammatory bowel disease (IBD) can raise some concerns among patients due to the self-administration concerns, the management of potential side effects and the overall worries related to a change of treatment. This study aimed at evaluating patients’ opinion about the switch from intravenous to subcutaneous formulations and their knowledge on new available therapeutic options.

Methods

We conducted a survey using a questionnaire prepared by a team of gastroenterologists and nurses working at the IBD unit. It consists of 31 items and has been divided into four sections: descriptive, commitment, knowledge and passage mode opinion. The questions were formulated in Italian and conceived according to daily consultations with patients in everyday practice, without any previous piloting or specific medical literature reference. The survey was administered to consecutive IBD patients in intravenous biological treatment; patients currently or previously treated with subcutaneous therapy were excluded.

Results

Four hundred questionnaires were distributed to participants. As many as 311 patients (77.7%) completed the survey, while the remaining were excluded from the analysis; 155 (49.8%) patients were favorable to switch from intravenous to subcutaneous therapy, while only 78 (25.1%) disagreed. In univariate and multi-variate analysis, the approval rate for home therapy was significantly associated with the distance from the IBD center and work/family/personal commitments. Surprisingly, only a quarter of the IBD patients knew that almost all available therapeutic agents have a subcutaneous administration route. Regarding patients’ opinion on the efficacy of subcutaneous administration of biological agents compared to intravenous drugs, 194 (63%) had no definite idea, while 44 (14%) believed that the effectiveness could be reduced.

Conclusion

The transition from in-hospital to subcutaneous therapeutic management of biological therapy at home was generally viewed favorably by patients, especially if they have commitments or were residents far from the IBD center.

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Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

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Acknowledgements

A special thanks to Fondazione Roma for the continuous and crucial support to our scientific research.

Author information

Authors and Affiliations

  1. CEMAD Digestive Disease Center, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Università Cattolica del Sacro Cuore, 00168, Rome, Italy

    Daniele Napolitano, Laura Parisio, Elisa Schiavoni, Laura Turchini, Lucrezia Laterza, Loris Riccardo Lopetuso, Daniela Pugliese, Alfredo Papa, Antonio Gasbarrini & Franco Scaldaferri

  2. UOSD Gastroenterologia ed Endoscopia Digestiva, IRCCS INRCA, 60127, Ancona, Italy

    Carlo Romano Settanni

  3. Fondazione Policlinico A. Gemelli IRCCS, 00168, Rome, Italy

    Nicoletta Orgiana & Andrea Poscia

  4. La Maddalena Cancer Center, Palermo, Italy

    Alessio Lo Cascio

  5. ASL Bari, Bari, Italy

    Francesco Germini

  6. Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Bari, Italy

    Elena Sblendorio

  7. Istituto Europeo di Oncologia, Milan, Italy

    Alessandra Milani

  8. Università Cattolica del Sacro Cuore, Rome, Italy

    Christopher Patteril

Authors
  1. Daniele Napolitano
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  2. Carlo Romano Settanni
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  3. Laura Parisio
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  4. Nicoletta Orgiana
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  5. Andrea Poscia
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  6. Elisa Schiavoni
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  10. Elena Sblendorio
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  11. Alessandra Milani
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  13. Lucrezia Laterza
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  14. Loris Riccardo Lopetuso
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  15. Daniela Pugliese
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  16. Alfredo Papa
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  18. Franco Scaldaferri
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Contributions

D.N. designed the research study. D.N., N.O., E.S., L.T., A.L.C., F.G. and A.M. collected data. D.N., C.R.S., A.P. and L.P. interpreted data and wrote the manuscript. D.N., D.P., C.P., L.L. and L.R.L. interpreted the results and reviewed the manuscript. A.P., A.G. and F.S. contributed with suggestions and reviewed and corrected the manuscript. All authors critically revised the manuscript, approved the final version to be published and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Daniele Napolitano.

Ethics declarations

Conflict of interest

DN, CRS, LP, NO, AP, ES, LT, ALC, FG, ESb, AM, CP, LL, LRL, DP, APa, AG and FS declare no competing interests.

Ethics statement

The study was performed conforming to the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

Ethical approval

The study protocol was approved by the Ethics Committee of the “A. Gemelli” IRCCS – Catholic University of the Sacred Heart of Rome. Questionnaires and informed consents will be kept for five years.

Consent to participate

Written informed consent was obtained for the processing of personal data issued by the subjects involved in the study, in accordance with current legislation on the protection of privacy. All participants provided this consent prior to filling in the questionnaire.

Disclaimer

The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/findings and content of this article.

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Napolitano, D., Settanni, C.R., Parisio, L. et al. Transition from intravenous to subcutaneous biological therapies in inflammatory bowel disease: An online survey of patients. Indian J Gastroenterol 43, 215–225 (2024). https://doi.org/10.1007/s12664-023-01500-2

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