TY - JOUR
T1 - Autologous hematopoetic stem cell transplantation for refractory Crohn disease a randomized clinical trial
AU - Hawkey, Christopher J.
AU - Allez, Matthieu
AU - Clark, Miranda M.
AU - Labopin, Myriam
AU - Lindsay, James O.
AU - Ricart, Elena
AU - Rogler, Gerhard
AU - Rovira, Montserrat
AU - Satsangi, Jack
AU - Danese, Silvio
AU - Russell, Nigel
AU - Gribben, John
AU - Johnson, Peter
AU - Larghero, Jerome
AU - Thieblemont, Catherine
AU - Ardizzone, Sandro
AU - Dierickx, Daan
AU - Ibatici, Adalberto
AU - Littlewood, Timothy
AU - Onida, Francesco
AU - Schanz, Urs
AU - Vermeire, Severine
AU - Colombel, Jean Frederic
AU - Jouet, Jean Paul
AU - Clark, Elizabeth
AU - Saccardi, Riccardo
AU - Tyndall, Alan
AU - Travis, Simon
AU - Farge, Dominique
PY - 2015/12/15
Y1 - 2015/12/15
N2 - 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)
AB - 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)
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U2 - 10.1001/jama.2015.16700
DO - 10.1001/jama.2015.16700
M3 - Article
C2 - 26670970
AN - SCOPUS:84950111817
VL - 314
SP - 2524
EP - 2534
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
SN - 0002-9955
IS - 23
ER -