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• W2977341289 abstract "Purpose: Binding of mucosal addressin cell adhesion molecule 1 (MAd-CAM-1) by α4β7 mediates migration of leukocytes into gastrointestinal mucosa and associated lymphoid tissue. Vedolizumab (VDZ) (previous versions MLN0002, MLN02, LDP-02) is an investigational gut-selective biologic that antagonizes α4β7. We describe the long-term clinical experience of 53 patients with mild to moderate ulcerative colitis (UC) who received VDZ for up to 2.5 years. Methods: UC patients were randomized to receive VDZ (2, 6, or 10 mg/kg) or placebo on days 1, 15, 29, and 85 in a dose-ranging study (DRS), after which (day 253) they could continue to receive VDZ 2 mg/kg q8 weeks in an open-label, long-term extension study (ES) for up to an additional 547 days. Partial Mayo score (PMS) was used to assess response to therapy through the final study visit (90 days after last dose). Safety, pharmacokinetics, pharmacodynamics, and immunogenicity were assessed at multiple time points. At ES completion, subjects were eligible to continue to receive VDZ in an ongoing, phase 3 safety extension trial (experience not included). Results: 38 patients received VDZ during the DRS and all continued in the ES. An additional 15 treatment-naïve patients were enrolled in the ES. 43 patients (81%) completed the ES. Reasons for discontinuation were lack of efficacy (n=5), adverse event (n=3) and withdrawal of consent (n=2). Pretreatment mean (SD) PMS was 3.7 (1.43) for the DRS and 5.4 (1.88) for the ES. At day 491 of the ES (before patients began enrolling into phase 3 ES), the mean (SD) PMS was 0.8 (1.15), and 88% of patients (n=43) were in clinical remission. Mean (SD) exposure to VDZ was 580.3 (167.2) days. During the ES, 70% of patients reported ≥1 adverse event (AE); 9% reported ≥1 serious AE. The most common AEs were nasopharyngitis (15%), headache (8%), cough (8%), arthralgia (4%) and URI (4%). One patient required hospitalization for a self-limited viral gastroenteritis, but no other serious infections were reported. One serious infusion reaction occurred in a patient who had been exposed to VDZ in a previous clinical trial. 3 patients (6%) developed human anti-human antibody to VDZ. There were no cases of progressive multifocal leukoencephalopathy or deaths during either study. Mean preinfusion serum VDZ concentrations were dose proportional and remained steady and detectable throughout the study with nearly full inhibition of α4β7 receptors. 29 patients (55%) elected to continue to receive VDZ in the phase 3 ES. Conclusion: Long-term VDZ administration was well tolerated, with a high rate of study completion. 2.0 mg/kg q 8 wks achieved target receptor saturation and was associated with durable mean decreases in disease activity. Disclosure: Drs. Parikh, Leach, and Xu - Shareholders of Takeda Pharmaceuticals, Employees of Millenium; Dr. Feagan - Grant/Research Support from Merck, Otsuka, Milllennium, Tillotts, Abbott, Protein Design Labs, Boehringer Engelheim, Novartis, Centocor, Berlex, Synta, Schering Canada, Elan/Biogen, UCB Pharma, BMS, Proctor and Gamble, Osiris, Genentech, CombinatoRx, ActoGeniX, Wyeth; Consultant for Synta, Millennium, Merck, Centocor, Elan/Biogen, Janssen-Ortho, Protein Design Labs, ISIS, Teva Pharmaceuticals, Santarus, Schering Plough, Bristol-Myers Squibb, Celgene, Combinatorx, UCB Pharma, Napo Pharma, Abbott, Proctor and Gamble, Osiris, Berlex, Astra Zeneca, GeneLogic Inc. Cerimon Pharm.,Tioga Pharm, Serono, Genentech, Tillotts, Unity Pharmaceuticals, Albireo Pharma, Given Imaging Inc., Salix Pharm., Ore Pharm.(previously GeneLogic), Novonordisk, GSK, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Alba Therapeutics, Axcan, Funxional Therapeutics, Gilead, Nektar, Pfizer, Shire, Wyeth, Zealand Pharm; Speakers Bureau for Astra Zeneca; Member, Scientific Advisory Board, Protein Design Labs, Astra Zeneca, Elan/Biogen, Celltech, Synta, Merck, Celgene, Novartis, Given Imaging Inc., UCB Pharma, Salix Pharmaceuticals, Abbott Laboratories, Centocor Inc. Pfizer, Axcan, Tillotts Pharma AG, Prometheus Laboratories." @default.
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• W2977341289 date "2011-10-01" @default.
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• W2977341289 title "Long-Term Clinical Experience with Vedolizumab in Patients with Mild to Moderate Ulcerative Colitis" @default.
• W2977341289 doi "https://doi.org/10.14309/00000434-201110002-01236" @default.
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