Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease
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. STARDUST was an international, multicenter, phase 3b, interventional, rando...
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| Veröffentlicht in: | Clinical gastroenterology and hepatology 2023-01, Vol.21 (1), p.153-163.e12 |
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| creator | Kucharzik, Torsten Wilkens, Rune D’Agostino, Maria-Antonietta Maconi, Giovanni Le Bars, Manuela Lahaye, Marjolein Bravatà, Ivana Nazar, Maciej Ni, Lioudmila Ercole, Elena Allocca, Mariangela Machková, Naděžda de Voogd, Floris A.E. Palmela, Carolina Vaughan, Rose Maaser, Christian Grega, Tomas Niangova, Ivana Repak, Rudolf Matejkova, Petra Vanickova, Radka Agerbæk, Juel Mie Cannon, Annett Giuliano, Vittorio Antoni, Christoph Büning, Jürgen Gebel, Michael Grewe, Martin Küpper, Sebastian Ryschka, Nikolas Potthoff, Andrej Reindl, Wolfgang Schliwa, Karolin Schulz, Martin Schulze, Hermann Krankenhaus, Markus Affronti, Marco Laura, Maria Bezzio, Christina Cavallaro, Flaminia Coletta, Marina Costantino, Andrea Furfaro, Federico Pizzolante, Fabrizio Bots, Steven De Knegt, Robert Bunganic, Ivan Opravil, Zdenek Poza, Joaquin Rimola, Jordi Ferrer, Cristina Suarez |
| description | 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.
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.
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%).
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
[Display omitted] |
| doi_str_mv | 10.1016/j.cgh.2022.05.055 |
| format | Article |
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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.
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%).
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
[Display omitted]</description><identifier>ISSN: 1542-3565</identifier><identifier>EISSN: 1542-7714</identifier><identifier>DOI: 10.1016/j.cgh.2022.05.055</identifier><identifier>PMID: 35842121</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Biological Products ; Colon ; Crohn Disease - diagnostic imaging ; Crohn Disease - drug therapy ; Crohn’s Disease ; Ecology, environment ; Health ; Humans ; Intestinal Ultrasound ; Life Sciences ; Remission Induction ; Reproducibility of Results ; STARDUST ; Transmural Remission ; Treatment Outcome ; Ustekinumab - therapeutic use</subject><ispartof>Clinical gastroenterology and hepatology, 2023-01, Vol.21 (1), p.153-163.e12</ispartof><rights>2023 The Authors</rights><rights>Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>Attribution</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-92ff5c246caa57d14aa62f852ca8efda384fd460faba303f8f342dd6617434123</citedby><cites>FETCH-LOGICAL-c430t-92ff5c246caa57d14aa62f852ca8efda384fd460faba303f8f342dd6617434123</cites><orcidid>0000-0002-0183-4483</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1542356522006498$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35842121$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://uvsq.hal.science/hal-04552336$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Kucharzik, Torsten</creatorcontrib><creatorcontrib>Wilkens, Rune</creatorcontrib><creatorcontrib>D’Agostino, Maria-Antonietta</creatorcontrib><creatorcontrib>Maconi, Giovanni</creatorcontrib><creatorcontrib>Le Bars, Manuela</creatorcontrib><creatorcontrib>Lahaye, Marjolein</creatorcontrib><creatorcontrib>Bravatà, Ivana</creatorcontrib><creatorcontrib>Nazar, Maciej</creatorcontrib><creatorcontrib>Ni, Lioudmila</creatorcontrib><creatorcontrib>Ercole, Elena</creatorcontrib><creatorcontrib>Allocca, Mariangela</creatorcontrib><creatorcontrib>Machková, Naděžda</creatorcontrib><creatorcontrib>de Voogd, Floris A.E.</creatorcontrib><creatorcontrib>Palmela, Carolina</creatorcontrib><creatorcontrib>Vaughan, Rose</creatorcontrib><creatorcontrib>Maaser, Christian</creatorcontrib><creatorcontrib>Grega, Tomas</creatorcontrib><creatorcontrib>Niangova, Ivana</creatorcontrib><creatorcontrib>Repak, Rudolf</creatorcontrib><creatorcontrib>Matejkova, Petra</creatorcontrib><creatorcontrib>Vanickova, Radka</creatorcontrib><creatorcontrib>Agerbæk, Juel Mie</creatorcontrib><creatorcontrib>Cannon, Annett</creatorcontrib><creatorcontrib>Giuliano, Vittorio</creatorcontrib><creatorcontrib>Antoni, Christoph</creatorcontrib><creatorcontrib>Büning, Jürgen</creatorcontrib><creatorcontrib>Gebel, Michael</creatorcontrib><creatorcontrib>Grewe, Martin</creatorcontrib><creatorcontrib>Küpper, Sebastian</creatorcontrib><creatorcontrib>Ryschka, Nikolas</creatorcontrib><creatorcontrib>Potthoff, Andrej</creatorcontrib><creatorcontrib>Reindl, Wolfgang</creatorcontrib><creatorcontrib>Schliwa, Karolin</creatorcontrib><creatorcontrib>Schulz, Martin</creatorcontrib><creatorcontrib>Schulze, Hermann</creatorcontrib><creatorcontrib>Krankenhaus, Markus</creatorcontrib><creatorcontrib>Affronti, Marco</creatorcontrib><creatorcontrib>Laura, Maria</creatorcontrib><creatorcontrib>Bezzio, Christina</creatorcontrib><creatorcontrib>Cavallaro, Flaminia</creatorcontrib><creatorcontrib>Coletta, Marina</creatorcontrib><creatorcontrib>Costantino, Andrea</creatorcontrib><creatorcontrib>Furfaro, Federico</creatorcontrib><creatorcontrib>Pizzolante, Fabrizio</creatorcontrib><creatorcontrib>Bots, Steven</creatorcontrib><creatorcontrib>De Knegt, Robert</creatorcontrib><creatorcontrib>Bunganic, Ivan</creatorcontrib><creatorcontrib>Opravil, Zdenek</creatorcontrib><creatorcontrib>Poza, Joaquin</creatorcontrib><creatorcontrib>Rimola, Jordi</creatorcontrib><creatorcontrib>Ferrer, Cristina Suarez</creatorcontrib><creatorcontrib>STARDUST Intestinal Ultrasound study group</creatorcontrib><title>Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease</title><title>Clinical gastroenterology and hepatology</title><addtitle>Clin Gastroenterol Hepatol</addtitle><description>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.
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.
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%).
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
[Display omitted]</description><subject>Adult</subject><subject>Biological Products</subject><subject>Colon</subject><subject>Crohn Disease - diagnostic imaging</subject><subject>Crohn Disease - drug therapy</subject><subject>Crohn’s Disease</subject><subject>Ecology, environment</subject><subject>Health</subject><subject>Humans</subject><subject>Intestinal Ultrasound</subject><subject>Life Sciences</subject><subject>Remission Induction</subject><subject>Reproducibility of Results</subject><subject>STARDUST</subject><subject>Transmural Remission</subject><subject>Treatment Outcome</subject><subject>Ustekinumab - therapeutic 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Wolfgang</creatorcontrib><creatorcontrib>Schliwa, Karolin</creatorcontrib><creatorcontrib>Schulz, Martin</creatorcontrib><creatorcontrib>Schulze, Hermann</creatorcontrib><creatorcontrib>Krankenhaus, Markus</creatorcontrib><creatorcontrib>Affronti, Marco</creatorcontrib><creatorcontrib>Laura, Maria</creatorcontrib><creatorcontrib>Bezzio, Christina</creatorcontrib><creatorcontrib>Cavallaro, Flaminia</creatorcontrib><creatorcontrib>Coletta, Marina</creatorcontrib><creatorcontrib>Costantino, Andrea</creatorcontrib><creatorcontrib>Furfaro, Federico</creatorcontrib><creatorcontrib>Pizzolante, Fabrizio</creatorcontrib><creatorcontrib>Bots, Steven</creatorcontrib><creatorcontrib>De Knegt, Robert</creatorcontrib><creatorcontrib>Bunganic, Ivan</creatorcontrib><creatorcontrib>Opravil, Zdenek</creatorcontrib><creatorcontrib>Poza, Joaquin</creatorcontrib><creatorcontrib>Rimola, Jordi</creatorcontrib><creatorcontrib>Ferrer, Cristina Suarez</creatorcontrib><creatorcontrib>STARDUST Intestinal Ultrasound study group</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>Clinical gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kucharzik, Torsten</au><au>Wilkens, Rune</au><au>D’Agostino, Maria-Antonietta</au><au>Maconi, Giovanni</au><au>Le Bars, Manuela</au><au>Lahaye, Marjolein</au><au>Bravatà, Ivana</au><au>Nazar, Maciej</au><au>Ni, Lioudmila</au><au>Ercole, Elena</au><au>Allocca, Mariangela</au><au>Machková, Naděžda</au><au>de Voogd, Floris A.E.</au><au>Palmela, Carolina</au><au>Vaughan, Rose</au><au>Maaser, Christian</au><au>Grega, Tomas</au><au>Niangova, Ivana</au><au>Repak, Rudolf</au><au>Matejkova, Petra</au><au>Vanickova, Radka</au><au>Agerbæk, Juel Mie</au><au>Cannon, Annett</au><au>Giuliano, Vittorio</au><au>Antoni, Christoph</au><au>Büning, Jürgen</au><au>Gebel, Michael</au><au>Grewe, Martin</au><au>Küpper, Sebastian</au><au>Ryschka, Nikolas</au><au>Potthoff, Andrej</au><au>Reindl, Wolfgang</au><au>Schliwa, Karolin</au><au>Schulz, Martin</au><au>Schulze, Hermann</au><au>Krankenhaus, Markus</au><au>Affronti, Marco</au><au>Laura, Maria</au><au>Bezzio, Christina</au><au>Cavallaro, Flaminia</au><au>Coletta, Marina</au><au>Costantino, Andrea</au><au>Furfaro, Federico</au><au>Pizzolante, Fabrizio</au><au>Bots, Steven</au><au>De Knegt, Robert</au><au>Bunganic, Ivan</au><au>Opravil, Zdenek</au><au>Poza, Joaquin</au><au>Rimola, Jordi</au><au>Ferrer, Cristina Suarez</au><aucorp>STARDUST Intestinal Ultrasound study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease</atitle><jtitle>Clinical gastroenterology and hepatology</jtitle><addtitle>Clin Gastroenterol Hepatol</addtitle><date>2023-01</date><risdate>2023</risdate><volume>21</volume><issue>1</issue><spage>153</spage><epage>163.e12</epage><pages>153-163.e12</pages><issn>1542-3565</issn><eissn>1542-7714</eissn><abstract>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.
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.
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%).
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
[Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>35842121</pmid><doi>10.1016/j.cgh.2022.05.055</doi><orcidid>https://orcid.org/0000-0002-0183-4483</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1542-3565 |
| ispartof | Clinical gastroenterology and hepatology, 2023-01, Vol.21 (1), p.153-163.e12 |
| issn | 1542-3565 1542-7714 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_04552336v1 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Biological Products Colon Crohn Disease - diagnostic imaging Crohn Disease - drug therapy Crohn’s Disease Ecology, environment Health Humans Intestinal Ultrasound Life Sciences Remission Induction Reproducibility of Results STARDUST Transmural Remission Treatment Outcome Ustekinumab - therapeutic use |
| title | Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-15T13%3A33%3A38IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Early%20Ultrasound%20Response%20and%20Progressive%20Transmural%20Remission%20After%20Treatment%20With%20Ustekinumab%20in%20Crohn%E2%80%99s%20Disease&rft.jtitle=Clinical%20gastroenterology%20and%20hepatology&rft.au=Kucharzik,%20Torsten&rft.aucorp=STARDUST%20Intestinal%20Ultrasound%20study%20group&rft.date=2023-01&rft.volume=21&rft.issue=1&rft.spage=153&rft.epage=163.e12&rft.pages=153-163.e12&rft.issn=1542-3565&rft.eissn=1542-7714&rft_id=info:doi/10.1016/j.cgh.2022.05.055&rft_dat=%3Cproquest_hal_p%3E2691051876%3C/proquest_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2691051876&rft_id=info:pmid/35842121&rft_els_id=S1542356522006498&rfr_iscdi=true |