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• W2334722120 abstract "Vedolizumab (VDZ) is a gut-selective monoclonal antibody to the α4β7 integrin for the treatment of moderately to severely active Crohn's disease (CD). The efficacy and safety of VDZ for CD were established in the placebo-controlled GEMINI 2 (NCT00783692)1 and GEMINI 3 (NCT01224171)2 trials and continue to be monitored in the ongoing open-label GEMINI Long-term Safety (LTS) trial (NCT00790933). Mucosal healing in CD—not pre-specified in any GEMINI trial—was previously demonstrated in 4 patients from GEMINI LTS.3 Here, we report follow-up of these 4 patients and evidence of initial and sustained mucosal healing in an additional 7 patients with CD receiving VDZ. Eligible patients (n = 9) from GEMINI 2 and GEMINI 3 were enrolled in GEMINI LTS and received VDZ 300 mg every 4 weeks. We treated an additional 2 patients with the approved VDZ induction and maintenance (dosed every 8 weeks) therapy outside of GEMINI LTS. Colonoscopic evaluations are a standard of care at our facility and were done before (up to 18 months before screening) and during the course of VDZ treatment. Retrospective chart reviews, including visual assessments of routine colonoscopies, for the 11 patients were described. Patients—6 men and 5 women—had a mean 13-year duration of CD with prior failure of tumor necrosis factor antagonist therapy. Seven patients had ileocolonic CD; 3 had disease involvement limited to the colon, and 1 to the small bowel. The majority of patients (n = 7) had a history of prior surgery for CD; 3 patients had a history of fistula. All 11 patients had significant mucosal ulcerations during baseline colonoscopic evaluation. Of patients previously demonstrating mucosal healing with VDZ,3 all 4 experienced sustained healing with continued treatment (≥4 years). Evidence of complete mucosal healing in 4 additional patients was observed with the second colonoscopy, performed within 1 to 4 years after initiating VDZ therapy. An additional 3 patients had partial mucosal healing upon their second colonoscopy, with complete healing observed at the third colonoscopy, 2.5 to 5 years after initiating VDZ therapy. Of all patients, mild recurrent CD was observed for 1 patient during a fifth colonoscopy, after >5 years of VDZ therapy. All patients experienced clinical benefit with VDZ therapy as evidenced by clinician and patient assessments. Endoscopic images show complete reversal of mucosal ulcerations in 11 patients with moderately to severely active CD within 1 to 5 years of VDZ therapy. Data provide evidence of sustained mucosal healing with long-term treatment in 10 patients; 1 patient experienced mild recurrent disease. Larger, prospective, controlled studies investigating the efficacy of VDZ in mucosal healing in CD are warranted." @default.
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• W2334722120 date "2016-03-01" @default.
• W2334722120 modified "2023-09-26" @default.
• W2334722120 title "P-006 Evidence of Mucosal Healing in Patients with Crohnʼs Disease Treated with Open-Label Vedolizumab" @default.
• W2334722120 cites W2077531651 @default.
• W2334722120 doi "https://doi.org/10.1097/01.mib.0000480052.94783.fd" @default.
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