Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease
Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved..
BACKGROUND & AIMS: Ustekinumab is an effective treatment of Crohn's disease (CD). Of interest to patients is knowing how soon symptoms may improve. We analyzed ustekinumab response dynamics from the ustekinumab CD trials.
METHODS: Patients with CD received intravenous induction with ustekinumab ∼6 mg/kg (n = 458) or placebo (n = 457). Week 8 ustekinumab responders received subcutaneous ustekinumab 90 mg as the first maintenance dose or as an extended induction dose for nonresponders. Patient-reported symptom changes (stool frequency, abdominal pain, general well-being) within the first 14 days and clinical outcomes through week 44 were evaluated using the CD Activity Index.
RESULTS: After ustekinumab infusion, stool frequency improvement was significantly (P < .05) greater than placebo on day 1 and for all patient-reported symptoms by day 10. In patients with no history of biologic failure or intolerance, cumulative clinical remission rates increased from 23.0% at week 3 to 55.5% at week 16 after the subcutaneous dose at week 8. Corresponding cumulative rates for patients with a history of biologic failure or intolerance increased from 12.9% to 24.1%. Neither change from baseline in CD Activity Index score nor week 8 ustekinumab pharmacokinetics were associated with week 16 response. Among all patients who received subcutaneous ustekinumab 90 mg q8w, up to 66.7% were in clinical response at week 44.
CONCLUSIONS: Ustekinumab induction provided symptom relief by day 1 post-infusion. Following ustekinumab infusion and a subcutaneous 90 mg injection, clinical outcomes continued to increase through week 16 and up to week 44. Regardless of week 8 clinical status or ustekinumab pharmacokinetics, patients should receive additional treatment at week 8.
CLINICALTRIALS: gov numbers, NCT01369329, NCT01369342, and NCT01369355.
| Errataetall: |
ErratumIn: Clin Gastroenterol Hepatol. 2024 Apr 3;:. - PMID 38582496 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association - 22(2024), 1 vom: 22. Jan., Seite 144-153.e2 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Colombel, Jean-Frédéric [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial |
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| Anmerkungen: |
Date Completed 27.12.2023 Date Revised 06.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT01369329, NCT01369342, NCT01369355 ErratumIn: Clin Gastroenterol Hepatol. 2024 Apr 3;:. - PMID 38582496 Citation Status MEDLINE |
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| doi: |
10.1016/j.cgh.2023.06.014 |
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| Förderinstitution / Projekttitel: |
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| 500 | |a Date Revised 06.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01369329, NCT01369342, NCT01369355 | ||
| 500 | |a ErratumIn: Clin Gastroenterol Hepatol. 2024 Apr 3;:. - PMID 38582496 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND & AIMS: Ustekinumab is an effective treatment of Crohn's disease (CD). Of interest to patients is knowing how soon symptoms may improve. We analyzed ustekinumab response dynamics from the ustekinumab CD trials | ||
| 520 | |a METHODS: Patients with CD received intravenous induction with ustekinumab ∼6 mg/kg (n = 458) or placebo (n = 457). Week 8 ustekinumab responders received subcutaneous ustekinumab 90 mg as the first maintenance dose or as an extended induction dose for nonresponders. Patient-reported symptom changes (stool frequency, abdominal pain, general well-being) within the first 14 days and clinical outcomes through week 44 were evaluated using the CD Activity Index | ||
| 520 | |a RESULTS: After ustekinumab infusion, stool frequency improvement was significantly (P < .05) greater than placebo on day 1 and for all patient-reported symptoms by day 10. In patients with no history of biologic failure or intolerance, cumulative clinical remission rates increased from 23.0% at week 3 to 55.5% at week 16 after the subcutaneous dose at week 8. Corresponding cumulative rates for patients with a history of biologic failure or intolerance increased from 12.9% to 24.1%. Neither change from baseline in CD Activity Index score nor week 8 ustekinumab pharmacokinetics were associated with week 16 response. Among all patients who received subcutaneous ustekinumab 90 mg q8w, up to 66.7% were in clinical response at week 44 | ||
| 520 | |a CONCLUSIONS: Ustekinumab induction provided symptom relief by day 1 post-infusion. Following ustekinumab infusion and a subcutaneous 90 mg injection, clinical outcomes continued to increase through week 16 and up to week 44. Regardless of week 8 clinical status or ustekinumab pharmacokinetics, patients should receive additional treatment at week 8 | ||
| 520 | |a CLINICALTRIALS: gov numbers, NCT01369329, NCT01369342, and NCT01369355 | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Crohn’s Disease | |
| 650 | 4 | |a Efficacy Dynamics | |
| 650 | 4 | |a Remission | |
| 650 | 4 | |a Response | |
| 650 | 4 | |a Ustekinumab | |
| 650 | 7 | |a Ustekinumab |2 NLM | |
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| 700 | 1 | |a Sands, Bruce E |e verfasserin |4 aut | |
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| 700 | 1 | |a Adedokun, Omoniyi J |e verfasserin |4 aut | |
| 700 | 1 | |a Izanec, James |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Tony |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Long-Long |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Scott D |e verfasserin |4 aut | |
| 700 | 1 | |a Targan, Stephan R |e verfasserin |4 aut | |
| 700 | 1 | |a Ghosh, Subrata |e verfasserin |4 aut | |
| 700 | 1 | |a Hanauer, Stephen B |e verfasserin |4 aut | |
| 700 | 1 | |a Sandborn, William J |e verfasserin |4 aut | |
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