Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.
Por:
Chaparro M, Garre A, Iborra M, Sierra M, Barreiro-de Acosta M, Fernandez-Clotet A, de Castro L, Bosca-Watts M, Casanova M, Lopez-Garcia A, Lorente R, Rodriguez C, Carbajo A, Arroyo M, Gutierrez A, Hinojosa J, Martinez-Perez T, Villoria A, Bermejo F, Busquets D, Camps B, Canete F, Mancenido N, Monfort D, Navarro-Llavat M, Perez-Calle J, Ramos L, Rivero M, Angueira T, Camo P, Carpio D, Garcia-de-la-Filia I, Gonzalez-Munoza C, Hernandez L, Huguet J, Morales V, Sicilia B, Vega P, Vera I, Zabana Y, Nos P, Suarez Alvarez P, Calvino-Suarez C, Ricart E, Hernandez V, Minguez M, Marquez L, Hervias Cruz D, Rubio Iturria S, Barrio J, Gargayo-Puyuelo C, Frances R, Hinojosa E, Del Moral M, Calvet X, Algaba A, Aldeguer X, Guardiola J, Manosa M, Pajares R, Piqueras M, Garcia-Bosch O, Lopez Serrano P, Castro B, Lucendo A, Montoro M, Castro Ortiz E, Mesonero F, Garcia-Planella E, Fuentes D, Bort I, Delgado-Guillena P, Arias L, Iglesias A, Calvo M, Esteve M, Domenech E, Gisbert J
Publicada:
16 abr 2021
Ahead of Print:
1 abr 2021
Resumen:
BACKGROUND: The development program (UNIFI) has shown promising results
of ustekinumab in ulcerative colitis (UC) treatment that should be
confirmed in clinical practice.
AIMS: To evaluate the durability, effectiveness and safety of
ustekinumab in UC in real-life.
METHODS: Patients included in the prospectively maintained ENEIDA
registry who received at least one intravenous dose of ustekinumab due
to active UC [Partial Mayo Score (PMS) >2] were included. Clinical
activity and effectiveness were defined based on PMS. Short-term
response was assessed at week 16.
RESULTS: A total of 95 patients were included. At week 16, 53% of
patients had response (including 35% of patients in remission). In the
multivariate analysis, elevated serum C-reactive protein was the only
variable significantly associated with lower likelihood of achieving
remission. Remission was achieved in 39% and 33% of patients at weeks 24
and 52, respectively. Thirty-six percent of patients discontinued the
treatment with ustekinumab during a median follow-up of 31 weeks. The
probability of maintaining ustekinumab treatment was 87% at week 16, 63%
at week 56, and 59% at week 72; primary failure was the main reason for
ustekinumab discontinuation. No variable was associated with risk of
discontinuation. Three patients reported adverse events; one of them had
a fatal severe SARS-CoV-2 infection.
CONCLUSIONS: Ustekinumab is effective both in the short and the
long-term in real-life, even in a highly refractory cohort. Higher
inflammatory burden at baseline correlated with lower probability of
achieving remission. Safety was consistent with the known profile of
ustekinumab.
Filiaciones:
Chaparro M:
ENEIDA registry
Garre A:
ENEIDA registry
Iborra M:
ENEIDA registry
Sierra M:
ENEIDA registry
Barreiro-de Acosta M:
ENEIDA registry
Fernandez-Clotet A:
ENEIDA registry
de Castro L:
ENEIDA registry
Bosca-Watts M:
Hospital Clinico de Valencia. Universitat de València, Valencia, Spain
Casanova M:
ENEIDA registry
Lopez-Garcia A:
ENEIDA registry
Lorente R:
ENEIDA registry
Rodriguez C:
ENEIDA registry
Carbajo A:
ENEIDA registry
Arroyo M:
ENEIDA registry
Gutierrez A:
ENEIDA registry
Hinojosa J:
ENEIDA registry
Martinez-Perez T:
ENEIDA registry
Villoria A:
ENEIDA registry
Bermejo F:
ENEIDA registry
Busquets D:
ENEIDA registry
Camps B:
ENEIDA registry
Canete F:
ENEIDA registry
Mancenido N:
ENEIDA registry
Monfort D:
ENEIDA registry
Navarro-Llavat M:
ENEIDA registry
Perez-Calle J:
ENEIDA registry
Ramos L:
ENEIDA registry
Rivero M:
ENEIDA registry
Angueira T:
ENEIDA registry
Camo P:
ENEIDA registry
Carpio D:
ENEIDA registry
Garcia-de-la-Filia I:
ENEIDA registry
Gonzalez-Munoza C:
ENEIDA registry
Hernandez L:
ENEIDA registry
Huguet J:
ENEIDA registry
Morales V:
ENEIDA registry
Sicilia B:
ENEIDA registry
Vega P:
ENEIDA registry
Vera I:
ENEIDA registry
Zabana Y:
ENEIDA registry
Nos P:
ENEIDA registry
Suarez Alvarez P:
ENEIDA registry
Calvino-Suarez C:
ENEIDA registry
Ricart E:
ENEIDA registry
Hernandez V:
ENEIDA registry
Minguez M:
Hospital Clinico de Valencia. Universitat de València, Valencia, Spain
Marquez L:
ENEIDA registry
Hervias Cruz D:
ENEIDA registry
Rubio Iturria S:
ENEIDA registry
Barrio J:
ENEIDA registry
Gargayo-Puyuelo C:
ENEIDA registry
Frances R:
ENEIDA registry
Hinojosa E:
ENEIDA registry
Del Moral M:
ENEIDA registry
Calvet X:
ENEIDA registry
Algaba A:
ENEIDA registry
Aldeguer X:
ENEIDA registry
Guardiola J:
ENEIDA registry
Manosa M:
ENEIDA registry
Pajares R:
ENEIDA registry
Piqueras M:
ENEIDA registry
Garcia-Bosch O:
ENEIDA registry
Lopez Serrano P:
ENEIDA registry
Castro B:
ENEIDA registry
Lucendo A:
ENEIDA registry
Montoro M:
ENEIDA registry
Castro Ortiz E:
ENEIDA registry
Mesonero F:
ENEIDA registry
Garcia-Planella E:
ENEIDA registry
Fuentes D:
ENEIDA registry
Bort I:
ENEIDA registry
Delgado-Guillena P:
ENEIDA registry
Arias L:
ENEIDA registry
Iglesias A:
ENEIDA registry
Calvo M:
ENEIDA registry
Esteve M:
ENEIDA registry
Domenech E:
ENEIDA registry
Gisbert J:
ENEIDA registry
Green Published, Green Accepted
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