Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease

<b>Background:</b> Ustekinumab (UST) has demonstrated effectiveness in treating patients with Crohn’s disease. Monitoring treatment response can improve disease management and reduce healthcare costs. We investigated whether UST trough levels (TLs), serum IL22, and Oncostatin M (OSM) lev...

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Main Authors: Luisa Bertin, Brigida Barberio, Alessandro Gubbiotti, Lorenzo Bertani, Francesco Costa, Linda Ceccarelli, Pierfrancesco Visaggi, Giorgia Bodini, Andrea Pasta, Renato Sablich, Maria Teresa Urbano, Antonio Ferronato, Andrea Buda, Manuela De Bona, Giulio Del Corso, Alessandro Massano, Imerio Angriman, Marco Scarpa, Fabiana Zingone, Edoardo Vincenzo Savarino
Format: Article
Language:English
Published: MDPI AG 2024-03-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/13/6/1539
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author Luisa Bertin
Brigida Barberio
Alessandro Gubbiotti
Lorenzo Bertani
Francesco Costa
Linda Ceccarelli
Pierfrancesco Visaggi
Giorgia Bodini
Andrea Pasta
Renato Sablich
Maria Teresa Urbano
Antonio Ferronato
Andrea Buda
Manuela De Bona
Giulio Del Corso
Alessandro Massano
Imerio Angriman
Marco Scarpa
Fabiana Zingone
Edoardo Vincenzo Savarino
author_facet Luisa Bertin
Brigida Barberio
Alessandro Gubbiotti
Lorenzo Bertani
Francesco Costa
Linda Ceccarelli
Pierfrancesco Visaggi
Giorgia Bodini
Andrea Pasta
Renato Sablich
Maria Teresa Urbano
Antonio Ferronato
Andrea Buda
Manuela De Bona
Giulio Del Corso
Alessandro Massano
Imerio Angriman
Marco Scarpa
Fabiana Zingone
Edoardo Vincenzo Savarino
author_sort Luisa Bertin
collection DOAJ
description <b>Background:</b> Ustekinumab (UST) has demonstrated effectiveness in treating patients with Crohn’s disease. Monitoring treatment response can improve disease management and reduce healthcare costs. We investigated whether UST trough levels (TLs), serum IL22, and Oncostatin M (OSM) levels could be early indicators of non-response by analysing their correlation with clinical and biochemical outcomes in CD. <b>Methods:</b> Patients with CD initiating UST treatment from October 2018 to September 2020 were enrolled at six Italian centres for inflammatory bowel disease (IBD). Clinical and biochemical data were collected at four time points: baseline, second subcutaneous (SC) dose, fourth SC dose, and 52 weeks. TLs were measured during maintenance, at the second SC dose, and at the fourth SC dose. IL-22 and OSM serum levels were assessed at baseline and the second SC dose. We analysed whether TLs, IL22 levels, and OSM serum levels were associated with clinical response, clinical remission, biochemical remission, and endoscopic remission using the appropriate statistical tests. <b>Results:</b> Out of eighty-four initially enrolled patients, five were lost to follow-up, and eleven discontinued the drug before 52 weeks. At the 52-week time point, 47% achieved biochemical remission based on faecal calprotectin levels, and 61.8% achieved clinical remission. TLs at the second SC dose significantly correlated with biochemical remission at the same time point (<i>p</i> = 0.011). However, TLs did not correlate with clinical remission. Baseline OSM levels did not correlate with biochemical or clinical remission or response. IL22 levels notably decreased during UST therapy (<i>p</i> = 0.000), but its values did not correlate with biochemical or clinical remission. <b>Conclusions:</b> UST is an effective therapy for patients with CD. TLs measured at the second SC dose significantly correlated with biochemical remission, emphasising their potential role in treatment monitoring. Levels of OSM and IL-22, despite a significant decrease in the latter during therapy, did not exhibit correlations with clinical or biochemical outcomes in our study. Further studies are needed to confirm these findings.
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spelling doaj.art-f8f0745e338b41b3b85f3924bb3fb27f2024-03-27T13:47:39ZengMDPI AGJournal of Clinical Medicine2077-03832024-03-01136153910.3390/jcm13061539Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s DiseaseLuisa Bertin0Brigida Barberio1Alessandro Gubbiotti2Lorenzo Bertani3Francesco Costa4Linda Ceccarelli5Pierfrancesco Visaggi6Giorgia Bodini7Andrea Pasta8Renato Sablich9Maria Teresa Urbano10Antonio Ferronato11Andrea Buda12Manuela De Bona13Giulio Del Corso14Alessandro Massano15Imerio Angriman16Marco Scarpa17Fabiana Zingone18Edoardo Vincenzo Savarino19Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, 35128 Padova, ItalyGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, 35128 Padova, ItalyGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, 35128 Padova, ItalyDepartment of General Surgery and Gastroenterology, Tuscany Northwest ASL—Pontedera Hospital, 56025 Pontedera, ItalyIBD Unit, Department of General Surgery, Pisa University Hospital, 56124 Pisa, ItalyIBD Unit, Department of General Surgery, Pisa University Hospital, 56124 Pisa, ItalyIBD Unit, Department of General Surgery, Pisa University Hospital, 56124 Pisa, ItalyGastrointestinal Unit, Department of Internal Medicine, University of Genoa, 16132 Genoa, ItalyGastrointestinal Unit, Department of Internal Medicine, University of Genoa, 16132 Genoa, ItalyGastroenterology Unit, Santa Maria Degli Angeli Hospital, 33170 Pordenone, ItalyGastroenterology Unit, Santa Maria Degli Angeli Hospital, 33170 Pordenone, ItalyEndoscopy Unit, Department of Medicine, ULSS7 “Pedemontana”, “Alto Vicentino” Hospital, 36014 Santorso, ItalyGastroenterology Unit, Department of Gastrointestinal Oncological Surgery, S. Maria del Prato Hospital, 32032 Feltre, ItalyGastroenterology Unit, Department of Gastrointestinal Oncological Surgery, S. Maria del Prato Hospital, 32032 Feltre, ItalyInstitute of Information Science and Technologies “A. Faedo”, National Research Council of Italy (CNR), 56124 Pisa, ItalyGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, 35128 Padova, ItalyThird Surgical Clinic Section, Department of Surgical, Oncological and Gastroenterological Sciences, Azienda Ospedale Università Padova, 35128 Padova, ItalyThird Surgical Clinic Section, Department of Surgical, Oncological and Gastroenterological Sciences, Azienda Ospedale Università Padova, 35128 Padova, ItalyGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, 35128 Padova, ItalyGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, 35128 Padova, Italy<b>Background:</b> Ustekinumab (UST) has demonstrated effectiveness in treating patients with Crohn’s disease. Monitoring treatment response can improve disease management and reduce healthcare costs. We investigated whether UST trough levels (TLs), serum IL22, and Oncostatin M (OSM) levels could be early indicators of non-response by analysing their correlation with clinical and biochemical outcomes in CD. <b>Methods:</b> Patients with CD initiating UST treatment from October 2018 to September 2020 were enrolled at six Italian centres for inflammatory bowel disease (IBD). Clinical and biochemical data were collected at four time points: baseline, second subcutaneous (SC) dose, fourth SC dose, and 52 weeks. TLs were measured during maintenance, at the second SC dose, and at the fourth SC dose. IL-22 and OSM serum levels were assessed at baseline and the second SC dose. We analysed whether TLs, IL22 levels, and OSM serum levels were associated with clinical response, clinical remission, biochemical remission, and endoscopic remission using the appropriate statistical tests. <b>Results:</b> Out of eighty-four initially enrolled patients, five were lost to follow-up, and eleven discontinued the drug before 52 weeks. At the 52-week time point, 47% achieved biochemical remission based on faecal calprotectin levels, and 61.8% achieved clinical remission. TLs at the second SC dose significantly correlated with biochemical remission at the same time point (<i>p</i> = 0.011). However, TLs did not correlate with clinical remission. Baseline OSM levels did not correlate with biochemical or clinical remission or response. IL22 levels notably decreased during UST therapy (<i>p</i> = 0.000), but its values did not correlate with biochemical or clinical remission. <b>Conclusions:</b> UST is an effective therapy for patients with CD. TLs measured at the second SC dose significantly correlated with biochemical remission, emphasising their potential role in treatment monitoring. Levels of OSM and IL-22, despite a significant decrease in the latter during therapy, did not exhibit correlations with clinical or biochemical outcomes in our study. Further studies are needed to confirm these findings.https://www.mdpi.com/2077-0383/13/6/1539inflammatory bowel diseaseCrohn’s diseaseOncostatin MIL-22ustekinumab trough levelsustekinumab
spellingShingle Luisa Bertin
Brigida Barberio
Alessandro Gubbiotti
Lorenzo Bertani
Francesco Costa
Linda Ceccarelli
Pierfrancesco Visaggi
Giorgia Bodini
Andrea Pasta
Renato Sablich
Maria Teresa Urbano
Antonio Ferronato
Andrea Buda
Manuela De Bona
Giulio Del Corso
Alessandro Massano
Imerio Angriman
Marco Scarpa
Fabiana Zingone
Edoardo Vincenzo Savarino
Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease
Journal of Clinical Medicine
inflammatory bowel disease
Crohn’s disease
Oncostatin M
IL-22
ustekinumab trough levels
ustekinumab
title Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease
title_full Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease
title_fullStr Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease
title_full_unstemmed Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease
title_short Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease
title_sort association between ustekinumab trough levels serum il 22 and oncostatin m levels and clinical and biochemical outcomes in patients with crohn s disease
topic inflammatory bowel disease
Crohn’s disease
Oncostatin M
IL-22
ustekinumab trough levels
ustekinumab
url https://www.mdpi.com/2077-0383/13/6/1539
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