Adalimumab in Biologic-naïve Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess : A Prospective Study From the GETAID
Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved..
BACKGROUND & AIMS: The management of intra-abdominal abscesses complicating Crohn's disease (CD) is challenging, and surgery with delayed intestinal resection is often recommended. The aims of this study were to estimate the success rate of adalimumab (ADA) in patients with CD with an intra-abdominal abscess resolved without surgery, and to identify predictive factors for success.
METHODS: A multicenter, prospective study was conducted in biologic-naïve patients with CD with resolved intra-abdominal abscess treated with ADA with a 2-year follow-up. The primary endpoint was ADA failure at week (W) 24 defined as a need for steroids after W12, intestinal resection, abscess recurrence, and clinical relapse. Secondary post-hoc endpoint was the long-term success defined as the survival without abscess relapse or intestinal resection at W104. The factors associated with ADA failure at W24 and W104 were identified using a logistic and a Cox regression, respectively.
RESULTS: From April 2013 to December 2017, 190 patients from 27 GETAID centers were screened, and 117 were included in the analysis. Fifty-eight patients (50%) were male, and the median age at baseline was 28 years. At W24, 87 patients (74%; 95% confidence interval [CI], 65.5%-82.0%; n = 117) achieved ADA success. Among the 30 patients with ADA failure, 15 underwent surgery. At W104, the survival rate without abscess recurrence or surgery was 72.9% (95% CI, 62.1%-79.8%; n = 109). Abscess drainage was significantly associated with ADA failure at W24 (odds ratio, 4.18; 95% CI, 1.06-16.5; P =0 .043). Disease duration (hazard ratio [HR], 1.32; 95% CI, 1.09-1.59; P = .008), abscess drainage (HR, 5.59; 95% CI, 2.21-14.15; P = .001), and inflammatory changes in mesenteric fat (HR, 0.4; 95% CI, 0.17-0.94; P = .046) were significantly associated with ADA failure at W104.
CONCLUSION: Provided that the abscess was carefully managed before initiating medical treatment, this study showed the high efficacy of ADA in the short and long term in biologic-naïve patients with CD complicated by an intra-abdominal abscess.
CLINICALTRIALS: gov, Number: NCT02856763.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
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| Enthalten in: |
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association - 21(2023), 13 vom: 01. Dez., Seite 3365-3378.e5 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bouhnik, Yoram [VerfasserIn] |
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| Links: |
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| Themen: |
Abscess |
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| Anmerkungen: |
Date Completed 27.11.2023 Date Revised 05.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02856763 Citation Status MEDLINE |
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| doi: |
10.1016/j.cgh.2023.01.013 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM352418117 |
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| 500 | |a ClinicalTrials.gov: NCT02856763 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND & AIMS: The management of intra-abdominal abscesses complicating Crohn's disease (CD) is challenging, and surgery with delayed intestinal resection is often recommended. The aims of this study were to estimate the success rate of adalimumab (ADA) in patients with CD with an intra-abdominal abscess resolved without surgery, and to identify predictive factors for success | ||
| 520 | |a METHODS: A multicenter, prospective study was conducted in biologic-naïve patients with CD with resolved intra-abdominal abscess treated with ADA with a 2-year follow-up. The primary endpoint was ADA failure at week (W) 24 defined as a need for steroids after W12, intestinal resection, abscess recurrence, and clinical relapse. Secondary post-hoc endpoint was the long-term success defined as the survival without abscess relapse or intestinal resection at W104. The factors associated with ADA failure at W24 and W104 were identified using a logistic and a Cox regression, respectively | ||
| 520 | |a RESULTS: From April 2013 to December 2017, 190 patients from 27 GETAID centers were screened, and 117 were included in the analysis. Fifty-eight patients (50%) were male, and the median age at baseline was 28 years. At W24, 87 patients (74%; 95% confidence interval [CI], 65.5%-82.0%; n = 117) achieved ADA success. Among the 30 patients with ADA failure, 15 underwent surgery. At W104, the survival rate without abscess recurrence or surgery was 72.9% (95% CI, 62.1%-79.8%; n = 109). Abscess drainage was significantly associated with ADA failure at W24 (odds ratio, 4.18; 95% CI, 1.06-16.5; P =0 .043). Disease duration (hazard ratio [HR], 1.32; 95% CI, 1.09-1.59; P = .008), abscess drainage (HR, 5.59; 95% CI, 2.21-14.15; P = .001), and inflammatory changes in mesenteric fat (HR, 0.4; 95% CI, 0.17-0.94; P = .046) were significantly associated with ADA failure at W104 | ||
| 520 | |a CONCLUSION: Provided that the abscess was carefully managed before initiating medical treatment, this study showed the high efficacy of ADA in the short and long term in biologic-naïve patients with CD complicated by an intra-abdominal abscess | ||
| 520 | |a CLINICALTRIALS: gov, Number: NCT02856763 | ||
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| 650 | 4 | |a Adalimumab | |
| 650 | 4 | |a Anti-TNF | |
| 650 | 4 | |a Crohn’s Disease | |
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| 700 | 1 | |a Nachury, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Seksik, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Altwegg, Romain |e verfasserin |4 aut | |
| 700 | 1 | |a Vuitton, Lucine |e verfasserin |4 aut | |
| 700 | 1 | |a Stefanescu, Carmen |e verfasserin |4 aut | |
| 700 | 1 | |a Nancey, Stéphane |e verfasserin |4 aut | |
| 700 | 1 | |a Aubourg, Alexandre |e verfasserin |4 aut | |
| 700 | 1 | |a Serrero, Mélanie |e verfasserin |4 aut | |
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| 700 | 1 | |a Desseaux, Kristell |e verfasserin |4 aut | |
| 700 | 1 | |a Viennot, Stéphanie |e verfasserin |4 aut | |
| 700 | 1 | |a Abitbol, Vered |e verfasserin |4 aut | |
| 700 | 1 | |a Boualit, Madina |e verfasserin |4 aut | |
| 700 | 1 | |a Bourreille, Arnaud |e verfasserin |4 aut | |
| 700 | 1 | |a Giletta, Cyrielle |e verfasserin |4 aut | |
| 700 | 1 | |a Buisson, Anthony |e verfasserin |4 aut | |
| 700 | 1 | |a Roblin, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Dib, Nina |e verfasserin |4 aut | |
| 700 | 1 | |a Malamut, Georgia |e verfasserin |4 aut | |
| 700 | 1 | |a Amiot, Aurélien |e verfasserin |4 aut | |
| 700 | 1 | |a Fumery, Mathurin |e verfasserin |4 aut | |
| 700 | 1 | |a Louis, Edouard |e verfasserin |4 aut | |
| 700 | 1 | |a Elgharabawy, Yasmine |e verfasserin |4 aut | |
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| 700 | 0 | |a MICA-GETAID Study Group |e verfasserin |4 aut | |
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| 700 | 1 | |a Treton, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Mailhat, Charlotte |e investigator |4 oth | |
| 700 | 1 | |a Pollet, Justine |e investigator |4 oth | |
| 700 | 1 | |a Martins, Carole |e investigator |4 oth | |
| 700 | 1 | |a Savoye, Guillaume |e investigator |4 oth | |
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