Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study

Abstract

ObjectiveThe efficacy of anti-tumour necrosis factors (anti-TNFs) in patients with Crohn's disease (CD) and symptomatic small bowel stricture (SSBS) is controversial. The aim of this study was to estimate the efficacy of adalimumab in these patients and to identify the factors predicting success.DesignWe performed a multicentre, prospective, observational cohort study in patients with CD and SSBS. The included patients underwent magnetic resonance enterography at baseline and subsequently received adalimumab. The primary endpoint was success at week 24, defined as adalimumab continuation without prohibited treatment (corticosteroids after the eight week following inclusion, other anti-TNFs), endoscopic dilation or bowel resection. The baseline factors independently associated with success were identified using a logistic regression model, leading to a simple prognostic score. Secondary endpoints were prolonged success after week 24 (still on adalimumab, without dilation nor surgery) and time to bowel resection in the whole cohort.ResultsFrom January 2010 to December 2011, 105 patients were screened and 97 were included. At week 24, 62/97 (64%) patients had achieved success. The prognostic score defined a good prognosis group with 43/49 successes, an intermediate prognosis group with 17/28 successes and a poor prognosis group with 1/16 successes. After a median follow-up time of 3.8 years, 45.7%±6.6% (proportion±SE) of patients who were in success at week 24 (ie, 29% of the whole cohort) were still in prolonged success at 4 years. Among the whole cohort, 50.7%±5.3% of patients did not undergo bowel resection 4 years after inclusion.ConclusionsA successful response to adalimumab was observed in about two-thirds of CD patients with SSBS and was prolonged in nearly half of them till the end of follow-up. More than half of the patients were free of surgery 4 years after treatment initiation.Clinical Trial registration numberNCT01183403; Results.

Mechanisms, Management, and Treatment of Fibrosis in Patients With Inflammatory Bowel Diseases

“…However, data from ultrasound studies 120 , the CD Resource, Evaluation and Assessment Tool (TREAT) registry, 121 and randomized controlled clinical trials 122 do not support this contention. A prospective multicenter observational cohort study (CREOLE) testing the effects of induction and maintenance therapy with the anti-TNF agent adalimumab in patients with CD with symptomatic small bowel strictures found that 61% of patients met the primary endpoint, at week 24, of requiring no steroid or need for endoscopic dilation no surgery, no adverse events, and no need for an alternate anti-TNF 123 . More than half of the patients fulfilled these criteria after 2 years treatment with adalimumab.…”

Endoscopic Balloon Dilation Size and Avoidance of Surgery in Stricturing Crohnʼs Disease

“…Anti-TNF initiation in newly diagnosed CD has been shown to reduce future surgery 16 . Further, in the CREOLE study of 97 patients with symptomatic strictures, bowel resection and endoscopic dilation were able to be avoiding following adalimumab initiation in 64% after 24 weeks and 29% after a median follow up of 4 years 17 . Yet, prior work by our group found that among patients hospitalized for small bowel obstruction due to stricturing CD, anti-TNF use did not reduce the risk of surgery 18 .…”

Unmet Therapeutic Needs: Focus on Intestinal Fibrosis Surgical Approach: Resection, Strictureplasty and Others

“…The success rate of adalimumab increased with the number of prognostic factors: from 6% in the presence of only 1 or 2 factors, to 89% in the presence of 4 factors at least. In this study, the median time to intestinal resection was 3.8 ± 0.1 years [25] . However, if patient is first treated with anti-TNF but it fails, it will need intestinal resection.…”