Introduction of Subcutaneous Infliximab CT-P13 and Vedolizumab in Clinical Practice: A Multi-Stakeholder Position Statement Highlighting the Need for Post-Marketing Studies.

Abstract

BACKGROUND AND AIMS:

Although subcutaneous formulations of infliximab CT-P13 and vedolizumab are registered for treating moderate-to-severe inflammatory bowel disease [IBD], many questions on their use remain unanswered. We set up a multi-stakeholder initiative resulting in a position statement.

METHODS:

Based on publicly available data, statements on subcutaneous infliximab and vedolizumab were developed and reviewed by 45 Belgian IBD physicians in a three-round modified Delphi process. During a consensus meeting, input from 16 IBD patients, nine IBD nurses and two clinical pharmacologists was provided and statements were further discussed, modified and scored. Statements achieving agreement by at least 70% of the IBD physicians were accepted.

RESULTS:

The Delphi process resulted in 79 agreed statements. In patients initiating intravenous therapy, IBD physicians would only consider switching to subcutaneous formulations in patients achieving both clinical and biological response [for Crohn's disease] or both clinical and endoscopic response [for ulcerative colitis]. For patients under maintenance therapy, switching to subcutaneous formulations was only considered in those achieving both clinical and endoscopic response while receiving standard dosing of infliximab or vedolizumab. While awaiting more scientific data, IBD physicians should consider weekly subcutaneous injections or switching back to an intravenous formulation in case of loss of response. Finally, switching to a subcutaneous formulation should always be a shared decision.

CONCLUSIONS:

All stakeholders welcomed subcutaneous infliximab and vedolizumab. However, more scientific data are needed to select the right patients and timing for switching to these newer formulations, and to explore the optimal strategy in case of loss of response.

• Authors: Liselotte Fierens, Claire Liefferinckx, Eveline Hoefkens, Triana Lobatòn, Erwin Dreesen, João Sabino, Marc Ferrante
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 16 Issue 7 Pg. 1059-1069 (Aug 04 2022) ISSN: 1876-4479 [Electronic] England
• PMID: 35078228 (Publication Type: Journal Article)
• Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: [email protected].

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Biosimilar Pharmaceuticals
• CT-P13
• Gastrointestinal Agents
• vedolizumab
• Infliximab

Topics

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Biosimilar Pharmaceuticals (therapeutic use)
• Colitis, Ulcerative (chemically induced, drug therapy)
• Gastrointestinal Agents
• Humans
• Inflammatory Bowel Diseases (chemically induced, drug therapy)
• Infliximab
• Marketing
• Treatment Outcome