Background & Aims: Vedolizumab is indicated for the treatment of chronic pouchitis in the European Union. We assessed whether vedolizumab induced mucosal healing (MH) and if MH was associated with clinical improvements.
Methods: EARNEST, a randomized, double-blind, placebo-controlled study, evaluated vedolizumab efficacy and safety in adults with chronic pouchitis. Centrally read endoscopic and histologic evaluation was performed at baseline, Week (W)14, and W34. Ulcer count, adapted Simple Endoscopic Score for Crohn's Disease in the pouch, and Pouchitis Disease Activity Index histologic component were evaluated. Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 were compared by MH status at W14.
Results: Following treatment, mean (standard deviation) number of ulcers in vedolizumab-treated patients reduced from 15.1 (16.4) to 5.0 (4.9) at W14 and 2.7 (3.2) at W34 versus placebo-treated patients with corresponding values of 11.8 (11.3), 13.4 (18.4), and 9.7 (13.8) (vedolizumab vs placebo difference [95% confidence interval]: W14: -8.4 [-14.3, -2.6]; W34: -7.0 [-12.0, -2.0]). More patients receiving vedolizumab versus placebo achieved reduction in ulcerated pouch surface area (W14: 52.4% vs 20.0%; difference, 32.4 percentage points [p.p] [9.7, 51.4]; W34: 52.1% vs 12.9%; difference, 40.2p.p [15.6, 60.3]), absence of ulceration (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [-2.0, 39.5]), Simple Endoscopic Score for Crohn's Disease remission (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [-2.0, 39.5]), and MH (W14: 16.7% vs 2.5%; difference, 14.2p.p [1.9, 26.4]). Patients with MH at W14 had higher rates of Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 than those without.
Conclusions: Vedolizumab induced endoscopic improvements in patients with chronic pouchitis, which was associated with improved outcomes at W34, particularly in patients achieving MH at W14. (ClinicalTrials.gov number, NCT02790138.).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.cgh.2024.06.037 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Preventive effect of Clostridium butyricum MIYAIRI against pouchitis in children with ulcerative colitis.
Surg Today
December 2024
Department of Gastrointestinal and Pediatric Surgery, Mie University Graduate School of Medicine, Edobashi 2-174, Tsu, Mie, 514-8507, Japan.
Purpose: Pouchitis is a major complication after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis in children (UCc). In this study, we investigated whether the oral administration of Clostridium butyricum MIYAIRI 588 (CBM) can reduce the incidence of pouchitis after IPAA in UCc.
Methods: We reviewed the data for pediatric patients with UC, who underwent IPAA in Mie University Hospital between 2004 and 2022.
Predictors of pouch failure and quality of life following ileal pouch-anal anastomosis for ulcerative colitis: a retrospective multicenter study.
ANZ J Surg
December 2024
Department of General Surgery, Division of Colorectal Surgery, Dokuz Eylül University, Izmir, Turkey.
Background: This study aimed to investigate the causes of failure after the ileal pouch-anal anastomosis (IPAA) procedure for ulcerative colitis (UC) and to determine the independent risk factors affecting their quality of life.
Methods: This multi-center cohort study included all UC patients who underwent IPAA at nine referral centers in Türkiye from 2010 to 2018. Centers were categorized as high-volume (≥10 cases/year) or low-volume (<10 cases/year).
Incidence, Risk Factors, and Outcomes of Chronic Antibiotic-Refractory Pouchitis in Korean Patients with Ulcerative Colitis.
Gut Liver
December 2024
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Background/aims: The study investigated the incidence, risk factors, and clinical outcomes of chronic antibiotic-refractory pouchitis (CARP) in Korean patients with ulcerative colitis (UC).
Methods: This single-center retrospective study included patients with UC who underwent total proctocolectomy with ileal pouch-anal anastomosis at the Asan Medical Center in Korea between January 1987 and December 2022. The primary outcomes were endoscopic remission and pouch failure.
Factors Associated With Biologic Therapy After Ileal Pouch-Anal Anastomosis in Patients With Ulcerative Colitis.
Inflamm Bowel Dis
November 2024
Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
Background: Patients with ulcerative colitis (UC) undergoing proctocolectomy and ileal pouch-anal anastomosis (IPAA) may eventually require biologic therapy. Factors associated with biologic therapy after IPAA have not been previously studied.
Methods: All patients with UC after total proctocolectomy and IPAA who were followed at Rabin Medical Center comprehensive pouch clinic and who consented to prospective observational follow-up were included.
Broadening perspectives in the treatment of chronic pouchitis.
Rev Esp Enferm Dig
December 2024
Digestive Diseases, Complejo Asistencial Universitario de León, España.
We present the case of a 64-year-old male diagnosed with corticosteroid-dependent ulcerative colitis in 1999, who underwent total proctocolectomy with a J-pouch in 2005. Three years later, he developed recurrent histologically confirmed pouchitis, with clinical worsening. Several therapies were tried, including Infliximab, which provided stability for six years, until the development of antibodies led to moderate pouchitis in the rectal stump.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!