Autologous hematopoetic stem cell transplantation for refractory Crohn disease a randomized clinical trial

Christopher J. Hawkey, Matthieu Allez, Miranda M. Clark, Myriam Labopin, James O. Lindsay, Elena Ricart, Gerhard Rogler, Montserrat Rovira, Jack Satsangi, Silvio Danese, Nigel Russell, John Gribben, Peter Johnson, Jerome Larghero, Catherine Thieblemont, Sandro Ardizzone, Daan Dierickx, Adalberto Ibatici, Timothy Littlewood, Francesco OnidaUrs Schanz, Severine Vermeire, Jean Frederic Colombel, Jean Paul Jouet, Elizabeth Clark, Riccardo Saccardi, Alan Tyndall, Simon Travis, Dominique Farge

Research output: Contribution to journalArticlepeer-review

Abstract

IMPORTANCE Case reports and series suggest hematopoietic stem cell transplantation (HSCT) may benefit some patients with Crohn disease. OBJECTIVE To evaluate the effect of autologous HSCT on refractory Crohn disease. DESIGN, SETTING, AND PARTICIPANTS Parallel-group randomized clinical trial conducted in 11 European transplant units from July 2007 to September 2011, with follow-up through March 2013. Patients were aged 18 to 50 years with impaired quality of life from refractory Crohn disease not amenable to surgery despite treatment with 3 or more immunosuppressive or biologic agents and corticosteroids. INTERVENTIONS All patients underwent stem cell mobilization before 1:1 randomization to immunoablation and HSCT (n = 23) or control treatment (HSCT deferred for 1 year [n = 22]). All were given standard Crohn disease treatment as needed. MAIN OUTCOMES AND MEASURES Sustained disease remission at 1 year, a composite primary end point comprising clinical remission (Crohn Disease Activity Index (CDAI)

Original languageEnglish
Pages (from-to)2524-2534
Number of pages11
JournalJournal of the American Medical Association
Volume314
Issue number23
DOIs
Publication statusPublished - Dec 15 2015

ASJC Scopus subject areas

  • Medicine(all)

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