Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial

Lancet
Severine VermeireWalter Reinisch

Abstract

PF-00547659 is a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) to selectively reduce lymphocyte homing to the intestinal tract. We aimed to assess the efficacy and safety of PF-00547659 in patients with moderate to severe ulcerative colitis. This phase 2, randomised, double-blind, placebo-controlled clinical trial recruited patients aged 18-65 years from 105 centres in 21 countries, with a history (≥3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score ≥6 and a Mayo endoscopic subscore ≥2) who had failed or were intolerant to at least one conventional therapy. Patients were stratified by previous anti-TNFα treatment, and randomly assigned by a computer-generated randomisation schedule to receive a subcutaneous injection of 7·5 mg, 22·5 mg, 75 mg, or 225 mg PF-00547659 or placebo at baseline, then every 4 weeks. Patients, investigators, and sponsors were blinded to the treatment. The primary endpoint was the proportion of patients achieving remission (total Mayo score ≤2 with no individual subscore >1 and rectal bleeding subscore ≤1) at week 12. The efficacy analysis included all patients who received at least on...Continue Reading

Citations

Mar 11, 2018·Scandinavian Journal of Gastroenterology·Bani AhluwaliaLena Öhman
Apr 7, 2018·Human Vaccines & Immunotherapeutics·Ignacio Catalan-Serra, Øystein Brenna
Apr 21, 2018·Annual Review of Immunology·Holm H Uhlig, Fiona Powrie
Mar 8, 2018·Scandinavian Journal of Gastroenterology·Axel DignassBruno Bonaz
Dec 11, 2017·The Korean Journal of Internal Medicine·Hyo Sun LeeDong Il Park
Jul 10, 2018·Expert Opinion on Investigational Drugs·Mariangela AlloccaSilvio Danese
Aug 6, 2018·Current Gastroenterology Reports·Siddharth Singh
Feb 2, 2018·Journal of Medicinal Food·Michael RohrSampath Parthasarathy
May 17, 2018·Journal of Crohn's & Colitis·Christopher A LambEugene C Butcher
Oct 31, 2018·Advances in Therapy·Roni WeisshofDavid T Rubin
Nov 18, 2018·Expert Opinion on Therapeutic Patents·Hao LiJi-Fu Wei
Jan 31, 2019·Expert Opinion on Biological Therapy·Marjolijn Duijvestein, Geert R D'Haens
Mar 22, 2019·Human Vaccines & Immunotherapeutics·Robert BattatNiels Vande Casteele
Jun 15, 2017·Nature Reviews. Gastroenterology & Hepatology·Iain Dickson
Mar 9, 2019·Current Pharmaceutical Design·Ferdinando D'AmicoSilvio Danese
Jul 13, 2017·Clinical Pharmacology and Therapeutics·Sarah Fischer, Markus F Neurath
Nov 12, 2019·Expert Opinion on Biological Therapy·Sherman Picardo, Remo Panaccione
Oct 1, 2019·Current Opinion in Gastroenterology·Sebastian ZundlerMarkus F Neurath
Mar 10, 2020·Expert Opinion on Emerging Drugs·Nicola PuglieseSilvio Danese
Apr 24, 2020·Immunological Medicine·Hiroshi Nakase
Sep 15, 2020·Expert Opinion on Drug Discovery·Dermot Cox
Dec 25, 2017·Digestive Diseases and Sciences·Paolo GiuffridaAntonio Di Sabatino
Aug 31, 2018·Inflammatory Bowel Diseases·Tamara Pérez-JeldresJesús Rivera-Nieves
Jun 18, 2019·Therapeutic Advances in Gastroenterology·João SabinoMarc Ferrante
Aug 23, 2019·World Journal of Gastroenterology : WJG·Jun-Hwan Yoo, Mark Donowitz
Jul 15, 2020·Digestive Diseases and Sciences·Neil NadparaFrank Friedenberg
Aug 15, 2017·Frontiers in Immunology·Sebastian ZundlerBritta Siegmund
Mar 21, 2018·Journal of Gastroenterology·Bram VerstocktGert Van Assche
Jun 6, 2018·Zeitschrift für Rheumatologie·S FischerM F Neurath
Nov 18, 2018·Inflammatory Bowel Diseases·Kenechukwu O Chudy-OnwugajeRaymond K Cross
Jun 14, 2019·Gut and Liver·Soo-Young Na, Won Moon
May 15, 2018·Journal of Crohn's & Colitis·Walter ReinischFabio Cataldi
Feb 23, 2020·Therapeutic Advances in Chronic Disease·Karl Hazel, Anthony O'Connor
Sep 12, 2020·Nature Reviews. Disease Primers·Taku KobayashiToshifumi Hibi
Jun 17, 2018·Mucosal Immunology·Sudarshan ParamsothyJean-Frederic Colombel

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