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Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease
Comparable Efficacy of Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease: A Retrospective Cohort Study
Background & Aims: Isolated small bowel Crohn's disease (CD) is defined by involvement of the ileum, jejunum, or extensive small intestinal segments in the absence of colonic disease. This phenotype presents a therapeutic challenge, as biologic agents demonstrate reduced efficacy in this subgroup. Data on the use of upadacitinib specifically for isolated small bowel CD remain limited. This study aimed to evaluate the efficacy of upadacitinib in patients with this phenotype using the International Bowel Ultrasound Segment Activity Score (IBUS-SAS).
Methods: A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted. Based on whether the disease involved the small bowel, individuals were categorized into an isolated small bowel CD group and a non-small bowel CD group. The primary endpoint was the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS) from baseline to week 12. Secondary endpoints at week 12 included radiographic response (defined as a>25% or>2.0 mm reduction in bowel wall thickness [BWT] from baseline, or a>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade), change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI) from baseline, and changes in laboratory parameters (C-reactive protein, erythrocyte sedimentation rate). Statistical analyses included between-group comparisons, within-group comparison and logistic regression to identify predictors of radiographic response.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Guangzhou
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Guangdong, Guangzhou, China, 510000
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- confirmed diagnosis of Crohn's disease (CD) based on the 2023 Chinese clinical practice guidelines (Guangzhou);
- initiated upadacitinib treatment (45 mg once daily) and completed at least 12 weeks of follow-up;
- underwent intestinal ultrasound examinations both before treatment initiation and at week 12
Exclusion Criteria:
- age <18 years;
- concomitant use of other CD medications during upadacitinib treatment, including glucocorticoids, mesalazine, immunosuppressants, or biologics;
- undergoing surgical intervention during the upadacitinib treatment period
- history of other gastrointestinal diseases (e.g., ulcerative colitis, intestinal tuberculosis);
- incomplete clinical data.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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case group:isolated small bowel Crohn's disease group
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A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.
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control group:a non-small bowel Crohn's disease group
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A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS)
Tijdsspanne: from baseline to week 12
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The maximum value of IBUS-SAS (International Bowel Ultrasound Segment Activity Score) is 100.
The theoretical minimum is 4, but the clinically effective minimum is 0. In general, the lower the score, the milder the intestinal inflammation.
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from baseline to week 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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radiographic response
Tijdsspanne: at week 12
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defined as a>25% or>2.0 mm reduction in bowel wall thickness [BWT] from baseline, or a>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade
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at week 12
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change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI)
Tijdsspanne: from baseline to week 12
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The Crohn's Disease Activity Index (CDAI) has a theoretical maximum of 1100 and a theoretical minimum of 0. Consistent with the definition of disease activity in this scoring system, the lower the score, the lower the disease activity and the better the clinical status.
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from baseline to week 12
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changes in laboratory parameters (C-reactive protein)
Tijdsspanne: from baseline to week 12
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from baseline to week 12
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changes in laboratory parameters (Erythrocyte sedimentation rate)
Tijdsspanne: from baseline to week 12
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from baseline to week 12
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Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.
- Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
- Dulai PS, Singh S, Vande Casteele N, Boland BS, Rivera-Nieves J, Ernst PB, Eckmann L, Barrett KE, Chang JT, Sandborn WJ. Should We Divide Crohn's Disease Into Ileum-Dominant and Isolated Colonic Diseases? Clin Gastroenterol Hepatol. 2019 Dec;17(13):2634-2643. doi: 10.1016/j.cgh.2019.04.040. Epub 2019 Apr 19.
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Studie voltooiing (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026ZSLYEC-305
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