Abstract
Vedolizumab, a humanized monoclonal antibody approved for the treatment of adults with moderately to severely active ulcerative colitis or Crohn disease, targets α4β7 integrin and selectively blocks gut-specific lymphocyte trafficking. The potential effects of vedolizumab on development were assessed by standard preclinical toxicity studies in rabbits and cynomolgus monkeys. A single infusion of vedolizumab (0, 10, 30, or 100 mg/kg) was administered intravenously to pregnant rabbits on gestational day 7; rabbits were monitored to gestational day 29. Vedolizumab (0, 10, or 100 mg/kg) was administered intravenously every 2 weeks to pregnant cynomolgus monkeys beginning on gestational day 20 with the last dose on gestational day 132 (9 doses total). In rabbits, vedolizumab did not affect maternal net body weight or net gains, gravid uterine weights, or mean maternal food consumption, nor did it affect intrauterine growth or fetal survival. There were also no vedolizumab effects on embryo-fetal development compared to controls. In cynomolgus monkeys, there was no increase in prenatal loss/death or stillbirth and no maternal toxicity associated with vedolizumab. On day 28 postpartum, low levels of vedolizumab were detected in the br...Continue Reading
References
Jun 5, 1999·Reviews of Reproduction·F SajiM Koyama
Jul 26, 2006·The American Journal of Gastroenterology·Lene RiisUNKNOWN European Collaborative study group on Inflammatory Bowel Disease
Dec 23, 2006·Gut·J CornishP P Tekkis
Sep 4, 2007·Gastroenterology·Uma MahadevanDouglas A Corley
Mar 12, 2009·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Nancy G WehnerJanet Clarke
Mar 14, 2009·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Nancy G WehnerJanet Clarke
Mar 14, 2009·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Nancy G WehnerJanet Clarke
Mar 19, 2009·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Nancy G WehnerJanet Clarke
Jul 25, 2009·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Nele Pentsuk, Jan Willem van der Laan
Dec 8, 2009·The American Journal of Cardiology·Gregory A NicholsJonathan B Brown
Dec 3, 2010·Journal of Crohn's & Colitis·R E MountifieldJ M Andrews
Dec 16, 2010·The American Journal of Gastroenterology·Uma MahadevanJean-Frederio Colombel
Mar 4, 2011·Alimentary Pharmacology & Therapeutics·Z ZelinkovaC J van der Woude
Apr 6, 2011·Gut·Craig MowatUNKNOWN IBD Section of the British Society of Gastroenterology
Dec 4, 2012·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Uma MahadevanMaria T Abreu
Jul 17, 2013·Alimentary Pharmacology & Therapeutics·A AbhyankarA C Moss
Aug 9, 2013·MAbs·Peter J K van MeerHuub Schellekens
Jan 7, 2014·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Christopher J BowmanSimon Chivers
Jan 21, 2015·Journal of Crohn's & Colitis·C J van der WoudeUNKNOWN European Crohn’s and Colitis Organization
Jun 18, 2015·PloS One·Heather A BoydTine Jess
Sep 2, 2015·Nature Reviews. Gastroenterology & Hepatology·Gilaad G Kaplan
Dec 22, 2015·Gastroenterology·Geoffrey C NguyenUNKNOWN Canadian Association of Gastroenterology
Mar 1, 2016·BJOG : an International Journal of Obstetrics and Gynaecology·A W ShandC L Roberts
Apr 29, 2016·Journal of Reproductive Immunology·Charlene PorterAndrew Nesbitt
Oct 23, 2016·Gastroenterology·Uma MahadevanChristina D Chambers
Jan 12, 2017·Gut·Mette JulsgaardDaniel C Baumgart
Feb 9, 2017·Alimentary Pharmacology & Therapeutics·U MahadevanM Dubinsky
Sep 1, 2017·Multiple Sclerosis : Clinical and Laboratory Research·Undine ProschmannTjalf Ziemssen
Sep 6, 2017·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Dawn B BeaulieuUma Mahadevan