Baseline Assessment of Serum Cytokines Predicts Clinical and Endoscopic Response to Ustekinumab in Patients With Crohn's Disease: A Prospective Pilot Study.

Crohn’s disease biologics cytokines mucosal healing ustekinumab

Journal

Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162

Informations de publication

Date de publication:
12 Jun 2024
Historique:
received: 30 12 2023
medline: 12 6 2024
pubmed: 12 6 2024
entrez: 12 6 2024
Statut: aheadofprint

Résumé

No biomarkers are currently available to predict therapeutic response to ustekinumab (UST) in Crohn's disease (CD). The aim of this prospective study was to identify 1 or more cytokines able to predict mucosal healing in patients with CD treated with UST. We prospectively enrolled consecutive CD patients treated with UST. At weeks 0 (baseline), 24, and 48, a panel of serum cytokines was measured by a fluorescence assay. At the same time points, fecal calprotectin (FC) was assessed. A colonoscopy was performed at baseline and at week 48, where therapeutic outcome was evaluated in terms of mucosal healing. Out of 44 patients enrolled, 22 (50%) achieved mucosal healing at the end of follow-up. Response was associated with higher interleukin (IL)-23 levels (P < .01). Fecal calprotectin levels decreased over time in responders but did not change in nonresponders (test for the interaction between time and mucosal healing, P < .001). This pilot study showed that IL-23 and FC could be reliable biomarkers in predicting therapeutic outcome to UST therapy in CD. In particular, the correlation between baseline serum levels of IL-23 and mucosal healing at 48 weeks is particularly strong, paving the way for its use to drive therapeutic decisions. This prospective pilot study showed that the assessment of IL-23 levels at baseline could predict clinical and endoscopic outcomes to ustekinumab therapy in Crohn’s disease. Testing this biomarker before starting a biological therapy could be useful for a personalized choice.

Sections du résumé

BACKGROUND BACKGROUND
No biomarkers are currently available to predict therapeutic response to ustekinumab (UST) in Crohn's disease (CD). The aim of this prospective study was to identify 1 or more cytokines able to predict mucosal healing in patients with CD treated with UST.
METHODS METHODS
We prospectively enrolled consecutive CD patients treated with UST. At weeks 0 (baseline), 24, and 48, a panel of serum cytokines was measured by a fluorescence assay. At the same time points, fecal calprotectin (FC) was assessed. A colonoscopy was performed at baseline and at week 48, where therapeutic outcome was evaluated in terms of mucosal healing.
RESULTS RESULTS
Out of 44 patients enrolled, 22 (50%) achieved mucosal healing at the end of follow-up. Response was associated with higher interleukin (IL)-23 levels (P < .01). Fecal calprotectin levels decreased over time in responders but did not change in nonresponders (test for the interaction between time and mucosal healing, P < .001).
CONCLUSIONS CONCLUSIONS
This pilot study showed that IL-23 and FC could be reliable biomarkers in predicting therapeutic outcome to UST therapy in CD. In particular, the correlation between baseline serum levels of IL-23 and mucosal healing at 48 weeks is particularly strong, paving the way for its use to drive therapeutic decisions.
This prospective pilot study showed that the assessment of IL-23 levels at baseline could predict clinical and endoscopic outcomes to ustekinumab therapy in Crohn’s disease. Testing this biomarker before starting a biological therapy could be useful for a personalized choice.

Autres résumés

Type: plain-language-summary (eng)
This prospective pilot study showed that the assessment of IL-23 levels at baseline could predict clinical and endoscopic outcomes to ustekinumab therapy in Crohn’s disease. Testing this biomarker before starting a biological therapy could be useful for a personalized choice.

Identifiants

pubmed: 38864707
pii: 7691749
doi: 10.1093/ibd/izae133
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Janssen Biotech spa

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

Auteurs

Lorenzo Bertani (L)

University of Pisa, Department of Translational Research and New Technologies in Medicine and Surgery, Via Roma, 67, 56100 Pisa, Italy.
Tuscany North West ASL, Department of General Surgery and Gastroenterology, Pontedera Hospital, Via Roma, 147, 56025, Pontedera, Italy.

Luca Antonioli (L)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Marco Fornili (M)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Vanessa D'Antongiovanni (V)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Linda Ceccarelli (L)

Pisa University Hospital, IBD Unit, Department of General Surgery and Gastroenterology, Via Paradisa, 2, 56124, Pisa, Italy.

Luca Carmisciano (L)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Laura Benvenuti (L)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Maria Gloria Mumolo (MG)

Pisa University Hospital, IBD Unit, Department of General Surgery and Gastroenterology, Via Paradisa, 2, 56124, Pisa, Italy.

Andrea Bottari (A)

University of Pisa, Department of Translational Research and New Technologies in Medicine and Surgery, Via Roma, 67, 56100 Pisa, Italy.

Veronica Pardi (V)

University of Pisa, Department of Translational Research and New Technologies in Medicine and Surgery, Via Roma, 67, 56100 Pisa, Italy.

Giovanni Baiano Svizzero (G)

Pisa University Hospital, IBD Unit, Department of General Surgery and Gastroenterology, Via Paradisa, 2, 56124, Pisa, Italy.

Laura Baglietto (L)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Nicola De Bortoli (N)

University of Pisa, Department of Translational Research and New Technologies in Medicine and Surgery, Via Roma, 67, 56100 Pisa, Italy.

Massimo Bellini (M)

University of Pisa, Department of Translational Research and New Technologies in Medicine and Surgery, Via Roma, 67, 56100 Pisa, Italy.

Matteo Fornai (M)

University of Pisa, Department of Clinical and Experimental Medicine, Via Roma, 67, 56100, Pisa, Italy.

Francesco Costa (F)

Pisa University Hospital, IBD Unit, Department of General Surgery and Gastroenterology, Via Paradisa, 2, 56124, Pisa, Italy.

Classifications MeSH