Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn’s Disease Recurrence. A GETECCU Randomised Trial

López-Sanromán, Antonio; Vera-Mendoza, Isabel; Domènech, Eugeni; Taxonera, Carlos; Ruı́z, Vicente Vega; Marín-Jiménez, Ignacio; Guardiola, Jordi; Castro, Luísa; Esteve, María; Iglesias, Eva; Ceballos, Daniel; Martínez-Montiel, Pilar; Gisbert, Javier P.; Mínguez, Miguel; Echarri, Ana; Calvet, Xavier; Barrio, Jesús; Hinojosa, Joaquín; Martín-Arranz, María Dolores; Márquez-Mosquera, Lucía; Bermejo, Fernando; Rimola, Jordi; Pons, Vicente; Nos, Pilar

doi:10.1093/ecco-jcc/jjx051

Cited by 63 publications

(50 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Interestingly the rate of previous intestinal resection was low in our cohort (17%) as compared to the POCER study where one‐third of patients had a previous intestinal resection or to the PREVENT study where 43% of patients had a previous resection within 10 years. Similarly, to a recent prospective cohort or to two recent controlled randomised studies, we did not identify penetrating disease as a risk factor for endoscopic recurrence . In a recent meta‐analysis B3 phenotype was identified as a risk factor, however, there was a high heterogeneity …”

Section: Discussionmentioning

confidence: 50%

“…Similarly, to a recent prospective cohort or to two recent controlled randomised studies, we did not identify penetrating disease as a risk factor for endoscopic recurrence. 4,15,21 In a recent meta-analysis B3 phenotype was identified as a risk factor, however, there was a high heterogeneity. 33 In our cohort, post-operative anti-TNF therapy was the only therapeutic drug associated with a reduction risk of endoscopic recurrence.…”

Section: Discussionmentioning

confidence: 99%

“…A sub‐analysis performed in the POCER study suggested that adalimumab may be superior to thiopurines in preventing early endoscopic post‐operative recurrence in high‐risk patients . In a recent randomised controlled trial, adalimumab was not superior to azathioprine to prevent post‐operative endoscopic recurrence at 1 year, but the population was not selected for high risk for recurrence …”

Section: Introductionmentioning

confidence: 99%

“…20 In a recent randomised controlled trial, adalimumab was not superior to azathioprine to prevent post-operative endoscopic recurrence at 1 year, but the population was not selected for high risk for recurrence. 21 The aim of our study was to identify predictors of post-operative endoscopic recurrence in a large prospective multicentric cohort of CD patients who underwent ileocolonic resection.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Male gender, active smoking and previous intestinal resection are risk factors for post‐operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study

Auzolle

Nancey

Tran‐Minh

et al. 2018

Aliment Pharmacol Ther

View full text Add to dashboard Cite

Summary Background After ileocaecal resection for Crohn's disease (CD), inflammatory lesions frequently recur on the anastomosis and/or on the neo‐terminal ileum. Aim To identify predictors of early post‐operative endoscopic recurrence. Methods From September 2010 to September 2017, the REMIND group conducted a prospective nationwide study in nine French academic centres. Data were collected at the time of surgery and endoscopy, performed 6‐12 months after surgery. Endoscopic recurrence was defined as a Rutgeerts score ≥i2. Baseline factors associated with endoscopic recurrence were searched by univariate and multivariate regression analysis. Results Two hundred and eighty‐nine CD patients were included. Endoscopy within 1 year following surgery was performed in 225 (78%) patients (104M/121F). Mean age and disease duration were 35 (12.2) and 8.8 (8.9) years respectively. Seventy (32%) patients were active smokers at surgery. One hundred and forty‐two (63%) patients received at least one anti‐TNF therapy before surgery. After surgery, 40 (18%) patients received thiopurines and 66 (29%) received an anti‐TNF agent. Endoscopic recurrence occurred in 107 (47%) patients. In multivariate analysis, male gender (OR = 2.48 [IC 95% 1.40‐4.46]), active smoking at surgery (OR = 2.65 [IC 95% 1.44‐4.97]) and previous resection (OR = 3.03 [IC 95% 1.36‐7.12]) were associated with a higher risk of endoscopic recurrence. Inversely, post‐operative anti‐TNF treatment decreased the risk of endoscopic recurrence (OR = 0.50 [IC 95% 0.25‐0.96]). Conclusions Male gender, active smoking at surgery and previous intestinal resection are associated with a higher risk of endoscopic post‐operative recurrence, while post‐operative anti‐TNF treatment is associated with a lower risk.

show abstract

Section: Discussionmentioning

confidence: 50%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Male gender, active smoking and previous intestinal resection are risk factors for post‐operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study

Auzolle

Nancey

Tran‐Minh

et al. 2018

Aliment Pharmacol Ther

View full text Add to dashboard Cite

show abstract

“…5 In this randomised controlled open-label study, 84 patients were randomised to receive either AZA 2.5 mg/kg body weight or ADM [160/80 mg induction and 40 mg fortnightly thereafter] within 2 weeks after the surgery. The primary endpoint was postoperative endoscopic recurrence at 1 year, defined as a modified Rutgeerts' score of at least i2b─more than five aphthous ulcers or larger lesions in the neoterminal ileum with normal mucosa in between [with or without anastomotic lesions].…”

mentioning

confidence: 99%

Management of Postoperative Crohn’s Disease: Missing Pieces of the Puzzle

Rivière

Ferrante

2017

Journal of Crohn's and Colitis

View full text Add to dashboard Cite

Despite the development of biological therapy, surgery is still needed in patients with refractory or complicated Crohn's disease. Thirty years ago, Rutgeerts et al. showed that postoperative clinical recurrence occurred early, affecting already one in five patients at 1 year, with endoscopic lesions preceding symptoms.1 Prevention and treatment of postoperative recurrence [POR] are important to avoid multiple resections and bowel destruction. Both thiopurines and antibodies targeting tumour necrosis factor [TNF] proved to prevent the development of postoperative endoscopic recurrence. 2,3 However, data on thiopurines in this setting are scarce and a Cochrane meta-analysis, published in 2014, could not conclude on a superiority of thiopurines over placebo. 4 Although indirect evidence suggested a better outcome with anti-TNF therapy, no head-to-head trials existed in order to choose between these two options.In that regard, the APPRECIA study─published in this issue of Journal of Crohn's and Colitis─is an interesting work addressing the head-to-head comparison of azathioprine [AZA] vs adalimumab [ADM] in the prevention of postoperative endoscopic recurrence. 5In this randomised controlled open-label study, 84 patients were randomised to receive either AZA 2.5 mg/kg body weight or ADM [160/80 mg induction and 40 mg fortnightly thereafter] within 2 weeks after the surgery. The primary endpoint was postoperative endoscopic recurrence at 1 year, defined as a modified Rutgeerts' score of at least i2b─more than five aphthous ulcers or larger lesions in the neoterminal ileum with normal mucosa in between [with or without anastomotic lesions]. 6 The superiority of ADM could not be proven: endoscopic recurrence rate in the AZA group was 59% [23/39] vs 42% [19/45] in the ADM group [p = 0.12].Although the study had a good design, it seems difficult to draw strong conclusions from these probably underpowered data. For their sample size calculation, the authors expected a 35% difference in POR between ADM and AZA groups. This was based on the tremendous effect of infliximab observed in the pilot study by Regueiro et al., with only 9% of POR at 1 year in the infliximab group vs 85% in the placebo group [delta 76%, p = 0.0006].3 Although the recently published PREVENT study also showed a significant difference between infliximab and placebo, the difference was much smaller, with 22% of POR in the infliximab group and 51% in the placebo group [delta 29%, p < 0.001].7 In both trials, POR was defined as a Rutgeerts' score of at least i2. Furthermore, in APPRECIA, the estimated drop-out rate of 10% was clearly underestimated [26% in PREVENT; 15% in POCER]. 7,8 Second, Lopez-Sanroman et al. chose to include all operated patients, without taking into account risk factors for POR like active smoking, previous resection, or penetrating disease. Although these risk factors have not been validated in a prospective setting, retrospective studies repeatedly showed their implication in POR.9 In POCER, the benefit of endoscopy-driven tr...

show abstract

Azathioprine and 6-mercaptopurine for maintenance of surgically-induced remission in Crohn's disease

Gjuladin-Hellon

Iheozor‐Ejiofor

Gordon

et al. 2019

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

show abstract

Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn’s Disease Recurrence. A GETECCU Randomised Trial

Abstract: ADA has not demonstrated a better efficacy than AZA [both associated with metronidazole] for prophylaxis of POR-CD in an unselected population, although tolerance to ADA is significantly better. ClinicalTrials.gov NCT01564823.

Cited by 63 publications

References 33 publications

Male gender, active smoking and previous intestinal resection are risk factors for post‐operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study

Male gender, active smoking and previous intestinal resection are risk factors for post‐operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study

Management of Postoperative Crohn’s Disease: Missing Pieces of the Puzzle

Azathioprine and 6-mercaptopurine for maintenance of surgically-induced remission in Crohn's disease

Contact Info

Product

Resources

About