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Multicenter Study
. 2023 Dec;21(13):3365-3378.e5.
doi: 10.1016/j.cgh.2023.01.013. Epub 2023 Jan 31.

Adalimumab in Biologic-naïve Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID

Yoram Bouhnik  1 , Guillaume Pineton de Chambrun  2 , Jérôme Lambert  3 , Maria Nachury  4 , Philippe Seksik  5 , Romain Altwegg  6 , Lucine Vuitton  7 , Carmen Stefanescu  8 , Stéphane Nancey  9 , Alexandre Aubourg  10 , Mélanie Serrero  11 , Jérôme Filippi  12 , Kristell Desseaux  3 , Stéphanie Viennot  13 , Vered Abitbol  14 , Madina Boualit  15 , Arnaud Bourreille  16 , Cyrielle Giletta  17 , Anthony Buisson  18 , Xavier Roblin  19 , Nina Dib  20 , Georgia Malamut  14 , Aurélien Amiot  21 , Mathurin Fumery  22 , Edouard Louis  23 , Yasmine Elgharabawy  24 , Laurent Peyrin-Biroulet  25 ; MICA-GETAID Study Group
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Free article
Multicenter Study

Adalimumab in Biologic-naïve Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID

Yoram Bouhnik et al. Clin Gastroenterol Hepatol. 2023 Dec.
Free article

Abstract

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.

Keywords: Abscess; Adalimumab; Anti-TNF; Crohn’s Disease; Surgery.

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