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STUDY PROTOCOL article

Front. Med.
Sec. Gastroenterology
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1458998

Comparison of ustekinumab, infliximab and combination therapy in moderately to severely active ulcerative colitis (COMBO-UC) -a study protocol of a randomized, multicenter, headto-head COMBO-UC trial

Provisionally accepted
Renata Talar-Wojnarowska Renata Talar-Wojnarowska 1Adam Fabisiak Adam Fabisiak 1*Hubert Zatorski Hubert Zatorski 1Katarzyna Płoszka Katarzyna Płoszka 2Katarzyna Błaziak Katarzyna Błaziak 2Wojciech Fendler Wojciech Fendler 2Grażyna Rydzewska Grażyna Rydzewska 3Ewa Malecka-Wojciesko Ewa Malecka-Wojciesko 1Piotr Eder Piotr Eder 4
  • 1 Department of Digestive Tract Disease, Medical University of Lodz, Lodz, Poland
  • 2 Department of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland
  • 3 Clinical Department of Internal Medicine and Gastroenterology with Inflammatory Bowel Disease Unit, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland
  • 4 Department of Gastroenterology, Dietetics and Internal Diseases, Poznan University of Medical Sciences, Poznan, Poland

The final, formatted version of the article will be published soon.

    Background: Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a complex etiology that affects the large intestine. Characterized by chronic, bloody diarrhea, UC can lead to severe complications, including an increased risk of colorectal cancer. Despite advancements in conservative treatment, including biologics like anti-TNF agents and ustekinumab (UST), many patients do not achieve full remission. Dual targeted therapy (DTT) combining infliximab (IFX) and UST is a promising approach to improve treatment outcomes.Methods: This prospective, randomized, multicenter, head-to-head controlled trial will evaluate the efficacy and safety of UST, IFX, and combination therapy (UST+IFX) in 172 patients with moderate to severe active UC across eight gastroenterology centers in Poland. The study includes a 14-16 week remission induction period followed by a 52-week maintenance phase. Patients will be randomly assigned to one of three treatment arms: IFX monotherapy, UST monotherapy, or IFX+UST combination therapy. Primary endpoint is clinical and endoscopic remission post-induction. Secondary endpoints include clinical response, biochemical remission, histological remission, and quality of life assessments using the Inflammatory Bowel Diseases Questionnaire and 36-Item Short Form Survey. Safety will be monitored through adverse event and serious adverse event reporting. Discussion: This trial aims to determine whether combining IFX and UST can achieve higher remission rates and better long-term outcomes compared to monotherapy. The results could provide crucial insights into the optimal use of biologic agents in UC treatment, potentially establishing DTT as a standard therapy. The study's design, including extensive follow-up and robust endpoint measures, will contribute to understanding the therapeutic potential and safety profile of this combination therapy

    Keywords: Inflammatory Bowel Diseases, ulcerative colitis, dual biological therapy, infliximab, Ustekinumab

    Received: 03 Jul 2024; Accepted: 02 Sep 2024.

    Copyright: © 2024 Talar-Wojnarowska, Fabisiak, Zatorski, Płoszka, Błaziak, Fendler, Rydzewska, Malecka-Wojciesko and Eder. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Adam Fabisiak, Department of Digestive Tract Disease, Medical University of Lodz, Lodz, Poland

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.