Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry

Mañosa, Míriam; Fernández-Clotet, A; Nos, Pilar; Martín-Arranz, María Dolores; Manceñido, Noemí; Carbajo, Ana Yaiza; Hinojosa, Esther; Hernández-Camba, Alejandro; Muñoz-Pérez, Roser; Boscá-Watts, Maia; Calvo, Marta; Sierra-Ausín, Mónica; Sánchez-Rodríguez, Eugenia; Acosta, Manuel Barreiro‐de; Núñez-Alonso, Alejandro; Zabana, Yamile; Márquez, Lucía; Gisbert, Javier P.; Guardiola, Jordi; Sainz, Empar; Delgado-Guillena, Pedro; Busquets, David; Domselaar, Manuel Van; Girona, Eva; Lorente, Rufo; Casas-Deza, D; Huguet, José María; Maestro, Sandra; Cabello, M. José; Castro, Jesús; Iborra, Marisa; Cañete, Fiorella; Calafat, Margalida; Domènech, Eugeni

doi:10.1016/j.dld.2022.07.013

Cited by 23 publications

(32 citation statements)

References 24 publications

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“…Yamada et al published a retrospective study looking at vedolizumab in the post-operative setting, finding that at rates of clinical (Harvey–Bradshaw index ≤ 4) remission were similar between patients receiving vedolizumab or anti-TNFα therapy at 6–12 months of follow-up, whereas rates of endoscopic remission, defined by simple endoscopic score for CD (SES-CD) of 0, was significantly decreased in patients receiving vedolizumab as compared with anti-TNFα therapy (25% vs 66%, P = 0.01) [ 77 ]. In a retrospective study looking at patients with CD receiving vedolizumab or ustekinumab after curative intestinal resection with ileocolonic anastomosis in the ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU, authors found that 40% of patients on vedolizumab and 42% of patients on ustekinumab had post-operative endoscopic recurrence (defined by Rutgeerts score > i1, with endoscopy within 18 months post-surgery) [ 78 ]. These rates are similar to those reported with anti-TNFα agents, e.g.…”

Section: Resultsmentioning

confidence: 99%

Post-operative prevention and monitoring of Crohn’s disease recurrence

Lee

Cantrell

Shen

et al. 2022

Gastroenterology Report

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Crohn’s disease (CD) and ulcerative colitis (UC) are relapsing and remitting chronic inflammatory diseases of the gastrointestinal tract. Although surgery for UC can provide a cure, surgery for CD is rarely curative. In the past few decades, research has identified risk factors for postsurgical CD recurrence, enabling patient risk stratification to guide monitoring and prophylactic treatment to prevent CD recurrence. A MEDLINE literature review identified articles regarding post-operative monitoring of CD recurrence after resection surgery. In this review, we discuss the evidence on risk factors for post-operative CD recurrence as well as suggestions on post-operative management.

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Section: Resultsmentioning

confidence: 99%

Post-operative prevention and monitoring of Crohn’s disease recurrence

Lee

Cantrell

Shen

et al. 2022

Gastroenterology Report

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“…Moreover, another retrospective study including CD patients with a prevention strategy with Vedolizumab or Ustekinumab showed similar efficacy between the two therapies. The cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for Ustekinumab and Vedolizumab, respectively [15].…”

Section: Discussionmentioning

confidence: 96%

“…Therefore, larger postoperative controlled trials are needed to establish the effectiveness of Vedolizumab on the rate of POR. Only a few data are available concerning the use of Vedolizumab for the prevention and treatment of POR, and only anecdotal experience or retrospective studies concerning its application in preventing POR [14][15][16]32].…”

Section: Discussionmentioning

confidence: 99%

“…However, only prophylactic treatment with anti-TNF showed more significant results [9]. In fact, a few RCTs showed a lower rate of endoscopic and clinical recurrence in patients treated with anti-TNFα compared to azathioprine or mesalamine [10][11][12][13], and only a few retrospective studies compared anti-TNFα or Ustekinumab and Vedolizumab showing conflicting results [14][15][16].…”

Section: Introductionmentioning

confidence: 99%

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Prophylactic Treatment with Vedolizumab in the Prevention of Postoperative Recurrence (POR) in High-Risk Crohn’s Patients

Frieri

Valvano

Frassino

et al. 2023

JCM

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About 50% of Crohn’s Disease (CD) patients undergo an intestinal resection during their lifetime. Although the patients experience a fairly long period of well-being after the intestinal resection, they presented a postoperative recurrence (POR) in 40% of cases within 5 years. In this case series, we aimed to evaluate the incidence of POR in CD patients with high risk for early POR, prophylactically treated with Vedolizumab. All consecutive CD patients (followed from 2017 to 2020) who underwent ileocolonic resection after the loss of response at anti-Tumor Necrosis Factor α (anti-TNFα) and with one or more risk factors for early POR were included. POR was defined as a Rutgeerts score (Ri) > 1 at the colonoscopic evaluation. All the included patients underwent a Magnetic resonance enterography (MRE) at least one year after the surgical resection. Six patients (4 Female; 2 Males) were included. At the first endoscopic evaluation, all patients were in endoscopic remission (5 patients Ri 0; 1 patient Ri 1). No stenosis nor other intestinal wall changes or complications were observed at MRE. Five patients underwent colonoscopy over two years of follow-up (median: 32 months; range 25–33). The Ri score was 0 in four patients, while the fifth patient showed severe endoscopic relapse. The same patient presented a clinical relapse (Harvey-Bradshaw index = 10) with a flare of disease in the colonic mucosa. These data suggest that early post-operative treatment with Vedolizumab could be a valuable strategy to be submitted to a prospective controlled trial for preventing POR.

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“…Unfortunately, surgery is not curative, and endoscopic recurrence at the anastomotic site occurs in up to 70% of patients in the first year after surgery, followed by clinical recurrence a few years later[ 2 ]. Postoperative management of these patients is crucial to identify those at highest risk of recurrence to begin rapid prophylactic treatments targeting mainly tumor necrosis factor α (TNFα)[ 3 ], interleukins 12/23 and α4β7 integrins on leukocytes[ 4 ]. Given the high rate of recurrence after intestinal resection for CD and the cost and potential adverse effects of biologic therapies used in prophylaxis, there is a clear need to identify the mechanisms leading to postoperative recurrence (POR), to develop noninvasive methods predicting recurrence and to propose new evidence-based therapeutic strategies.…”

Section: Introductionmentioning

confidence: 99%

Saccharomyces cerevisiae prevents postoperative recurrence of Crohn's disease modeled by ileocecal resection in HLA-B27 transgenic rats

Valibouze¹,

Speca²,

Dubuquoy³

et al. 2023

World J Gastroenterol

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BACKGROUND Postoperative recurrence (POR) after ileocecal resection (ICR) affects most Crohn's disease patients within 3-5 years after surgery. Adherent-invasive Escherichia coli (AIEC) typified by the LF82 strain are pathobionts that are frequently detected in POR of Crohn's disease and have a potential role in the early stages of the disease pathogenesis. Saccharomyces cerevisiae CNCM I-3856 is a probiotic yeast reported to inhibit AIEC adhesion to intestinal epithelial cells and to favor their elimination from the gut. AIM To evaluate the efficacy of CNCM I-3856 in preventing POR induced by LF82 in an HLA-B27 transgenic (TgB27) rat model. METHODS Sixty-four rats [strain F344, 38 TgB27, 26 control non-Tg (nTg)] underwent an ICR at the 12 th wk (W12) of life and were sacrificed at the 18 th wk (W18) of life. TgB27 rats were challenged daily with oral administration of LF82 (10 9 colony forming units (CFUs)/day (d), n = 8), PBS ( n = 5), CNCM I-3856 (10 9 CFUs/d, n = 7) or a combination of LF82 and CNCM I-3856 ( n = 18). nTg rats receiving LF82 ( n = 5), PBS ( n = 5), CNCM I-3856 ( n = 7) or CNCM I-3856 and LF82 ( n = 9) under the same conditions were used as controls. POR was analyzed using macroscopic (from 0 to 4) and histologic (from 0 to 6) scores. Luminal LF82 quantifications were performed weekly for each animal. Adherent LF82 and inflammatory/regulatory cytokines were quantified in biopsies at W12 and W18. Data are expressed as the median with the interquartile range. RESULTS nTg animals did not develop POR. A total of 7/8 (87%) of the TgB27 rats receiving LF82 alone had POR (macroscopic score ≥ 2), which was significantly prevented by CNCM I-3856 administration [6/18 (33%) TgB27 rats, P = 0.01]. Macroscopic lesions were located 2 cm above the anastomosis in the TgB27 rats receiving LF82 alone and consisted of ulcerations with a score of 3.5 (2 - 4). Seven out of 18 TgB27 rats (39%) receiving CNCM I-3856 and LF82 had no macroscopic lesions. Compared to untreated TgB27 animals receiving LF82 alone, coadministration of CNCM I-3856 and LF82 significantly reduced the macroscopic [3.5 (2 - 4) vs 1 (0 - 3), P = 0.002] and histological lesions by more than 50% [4.5 (3.3 - 5.8) vs 2 (1.3 - 3), P = 0.003]. The levels of adherent LF82 were correlated with anastomotic macroscopic scores in TgB27 rats ( r = 0.49, P = 0.006), with a higher risk of POR in anim...

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Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry

Cited by 23 publications

References 24 publications

Post-operative prevention and monitoring of Crohn’s disease recurrence

Post-operative prevention and monitoring of Crohn’s disease recurrence

Prophylactic Treatment with Vedolizumab in the Prevention of Postoperative Recurrence (POR) in High-Risk Crohn’s Patients

Saccharomyces cerevisiae prevents postoperative recurrence of Crohn's disease modeled by ileocecal resection in HLA-B27 transgenic rats

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