Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease

Torsten Kucharzik; Rune Wilkens; Maria Antonietta D'Agostino; Giovanni Maconi; Manuela Le Bars; Marjolein Lahaye; Ivana Bravatà; Maciej Nazar; Lioudmila Ni; Elena Ercole; Mariangela Allocca; Naděžda Machková; Floris A. E. de Voogd; Carolina Palmela; Rose Vaughan; Christian Maaser; Tomas Grega; Ivana Niangova; Rudolf Repak; Petra Matejkova; Radka Vanickova; Juel Mie Agerbæk; Annett Cannon; Giuliano Vittorio Mussati; Christoph Antoni; Jürgen Büning; Michael Gebel; Martin Grewe; Sebastian Küpper; Nikolas Ryschka; Andrej Potthoff; Wolfgang Reindl; Karolin Schliwa; Martin Schulz; Hermann Schulze; Markus Krankenhaus; Marco Affronti; Maria Laura De Simone; Christina Bezzio; Flaminia Cavallaro; Marina Coletta; Andrea Costantino; Federico Furfaro; Fabrizio Pizzolante; Steven Bots; Robert De Knegt; Ivan Bunganic; Zdenek Opravil; Joaquin Poza; Jordi Rimola; Cristina Suarez Ferrer

doi:10.1016/j.cgh.2022.05.055

Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease

Torsten Kucharzik, Rune Wilkens, Maria Antonietta D'Agostino, Giovanni Maconi, Manuela Le Bars, Marjolein Lahaye, Ivana Bravatà, Maciej Nazar, Lioudmila Ni, Elena Ercole, Mariangela Allocca, Naděžda Machková, Floris A. E. de Voogd, Carolina Palmela, Rose Vaughan, Christian Maaser, Tomas Grega, Ivana Niangova, Rudolf Repak, Petra MatejkovaRadka Vanickova, Juel Mie Agerbæk, Annett Cannon, Giuliano Vittorio Mussati, Christoph Antoni, Jürgen Büning, Michael Gebel, Martin Grewe, Sebastian Küpper, Nikolas Ryschka, Andrej Potthoff, Wolfgang Reindl, Karolin Schliwa, Martin Schulz, Hermann Schulze, Markus Krankenhaus, Marco Affronti, Maria Laura De Simone, Christina Bezzio, Flaminia Cavallaro, Marina Coletta, Andrea Costantino, Federico Furfaro, Fabrizio Pizzolante, Steven Bots, Robert De Knegt, Ivan Bunganic, Zdenek Opravil, Joaquin Poza, Jordi Rimola, Cristina Suarez Ferrer

Risultato della ricerca: Contributo in rivista › Articolo in rivista

Abstract

Background & aims: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure. Methods: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat. Results: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21-0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%). Conclusions: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients. Clinicaltrials: gov number: NCT03107793.

Lingua originale	English
pagine (da-a)	N/A-N/A
Rivista	Clinical Gastroenterology and Hepatology
Volume	2022
DOI	https://doi.org/10.1016/j.cgh.2022.05.055
Stato di pubblicazione	Pubblicato - 2022

Keywords

Crohn’s Disease, Intestinal Ultrasound, Transmural Remission

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10.1016/j.cgh.2022.05.055

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Kucharzik, T., Wilkens, R., D'Agostino, M. A., Maconi, G., Le Bars, M., Lahaye, M., Bravatà, I., Nazar, M., Ni, L., Ercole, E., Allocca, M., Machková, N., de Voogd, F. A. E., Palmela, C., Vaughan, R., Maaser, C., Grega, T., Niangova, I., Repak, R., ... Ferrer, C. S. (2022). Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease. Clinical Gastroenterology and Hepatology, 2022, N/A-N/A. https://doi.org/10.1016/j.cgh.2022.05.055

@article{2c45909fb0b04fd3b929f7f9fe81d3b8,

title = "Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn{\textquoteright}s Disease",

abstract = "Background & aims: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure. Methods: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat. Results: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21-0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%). Conclusions: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients. Clinicaltrials: gov number: NCT03107793.",

keywords = "Crohn{\textquoteright}s Disease, Intestinal Ultrasound, Transmural Remission, Crohn{\textquoteright}s Disease, Intestinal Ultrasound, Transmural Remission",

author = "Torsten Kucharzik and Rune Wilkens and D'Agostino, {Maria Antonietta} and Giovanni Maconi and {Le Bars}, Manuela and Marjolein Lahaye and Ivana Bravat{\`a} and Maciej Nazar and Lioudmila Ni and Elena Ercole and Mariangela Allocca and Nad{\v e}{\v z}da Machkov{\'a} and {de Voogd}, {Floris A. E.} and Carolina Palmela and Rose Vaughan and Christian Maaser and Tomas Grega and Ivana Niangova and Rudolf Repak and Petra Matejkova and Radka Vanickova and Agerb{\ae}k, {Juel Mie} and Annett Cannon and Mussati, {Giuliano Vittorio} and Christoph Antoni and J{\"u}rgen B{\"u}ning and Michael Gebel and Martin Grewe and Sebastian K{\"u}pper and Nikolas Ryschka and Andrej Potthoff and Wolfgang Reindl and Karolin Schliwa and Martin Schulz and Hermann Schulze and Markus Krankenhaus and Marco Affronti and {De Simone}, {Maria Laura} and Christina Bezzio and Flaminia Cavallaro and Marina Coletta and Andrea Costantino and Federico Furfaro and Fabrizio Pizzolante and Steven Bots and {De Knegt}, Robert and Ivan Bunganic and Zdenek Opravil and Joaquin Poza and Jordi Rimola and Ferrer, {Cristina Suarez}",

year = "2022",

doi = "10.1016/j.cgh.2022.05.055",

language = "English",

volume = "2022",

pages = "N/A--N/A",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders",

}

Kucharzik, T, Wilkens, R, D'Agostino, MA, Maconi, G, Le Bars, M, Lahaye, M, Bravatà, I, Nazar, M, Ni, L, Ercole, E, Allocca, M, Machková, N, de Voogd, FAE, Palmela, C, Vaughan, R, Maaser, C, Grega, T, Niangova, I, Repak, R, Matejkova, P, Vanickova, R, Agerbæk, JM, Cannon, A, Mussati, GV, Antoni, C, Büning, J, Gebel, M, Grewe, M, Küpper, S, Ryschka, N, Potthoff, A, Reindl, W, Schliwa, K, Schulz, M, Schulze, H, Krankenhaus, M, Affronti, M, De Simone, ML, Bezzio, C, Cavallaro, F, Coletta, M, Costantino, A, Furfaro, F, Pizzolante, F, Bots, S, De Knegt, R, Bunganic, I, Opravil, Z, Poza, J, Rimola, J & Ferrer, CS 2022, 'Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease', Clinical Gastroenterology and Hepatology, vol. 2022, pagg. N/A-N/A. https://doi.org/10.1016/j.cgh.2022.05.055

TY - JOUR

T1 - Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease

AU - Kucharzik, Torsten

AU - Wilkens, Rune

AU - D'Agostino, Maria Antonietta

AU - Maconi, Giovanni

AU - Le Bars, Manuela

AU - Lahaye, Marjolein

AU - Bravatà, Ivana

AU - Nazar, Maciej

AU - Ni, Lioudmila

AU - Ercole, Elena

AU - Allocca, Mariangela

AU - Machková, Naděžda

AU - de Voogd, Floris A. E.

AU - Palmela, Carolina

AU - Vaughan, Rose

AU - Maaser, Christian

AU - Grega, Tomas

AU - Niangova, Ivana

AU - Repak, Rudolf

AU - Matejkova, Petra

AU - Vanickova, Radka

AU - Agerbæk, Juel Mie

AU - Cannon, Annett

AU - Mussati, Giuliano Vittorio

AU - Antoni, Christoph

AU - Büning, Jürgen

AU - Gebel, Michael

AU - Grewe, Martin

AU - Küpper, Sebastian

AU - Ryschka, Nikolas

AU - Potthoff, Andrej

AU - Reindl, Wolfgang

AU - Schliwa, Karolin

AU - Schulz, Martin

AU - Schulze, Hermann

AU - Krankenhaus, Markus

AU - Affronti, Marco

AU - De Simone, Maria Laura

AU - Bezzio, Christina

AU - Cavallaro, Flaminia

AU - Coletta, Marina

AU - Costantino, Andrea

AU - Furfaro, Federico

AU - Pizzolante, Fabrizio

AU - Bots, Steven

AU - De Knegt, Robert

AU - Bunganic, Ivan

AU - Opravil, Zdenek

AU - Poza, Joaquin

AU - Rimola, Jordi

AU - Ferrer, Cristina Suarez

PY - 2022

Y1 - 2022

N2 - Background & aims: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure. Methods: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat. Results: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21-0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%). Conclusions: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients. Clinicaltrials: gov number: NCT03107793.

AB - Background & aims: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure. Methods: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat. Results: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21-0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%). Conclusions: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients. Clinicaltrials: gov number: NCT03107793.

KW - Crohn’s Disease, Intestinal Ultrasound, Transmural Remission

UR - http://hdl.handle.net/10807/221892

U2 - 10.1016/j.cgh.2022.05.055

DO - 10.1016/j.cgh.2022.05.055

M3 - Article

SN - 1542-3565

VL - 2022

SP - N/A-N/A

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

ER -

Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease

Abstract

Keywords

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