RT Journal Article
T1 Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study.
A1 Chaparro, Maria
A1 Baston-Rey, Iria
A1 Fernandez-Salgado, Estela
A1 Gonzalez-Garcia, Javier
A1 Ramos, Laura
A1 Diz-Lois Palomares, Maria Teresa
A1 Arguelles-Arias, Federico
A1 Iglesias-Flores, Eva
A1 Cabello, Mercedes
A1 Rubio-Iturria, Saioa
A1 Nuñez-Ortiz, Andrea
A1 Charro, Mara
A1 Ginard, Daniel
A1 Dueñas-Sadornil, Carmen
A1 Merino-Ochoa, Olga
A1 Busquets, David
A1 Iyo, Eduardo
A1 Gutierrez-Casbas, Ana
A1 Ramirez-de-la-Piscina, Patricia
A1 Bosca-Watts, Marta Maia
A1 Arroyo, Maite
A1 Garcia, Maria Jose
A1 Hinojosa, Esther
A1 Gordillo, Jordi
A1 Martinez-Montiel, Pilar
A1 Velayos-Jimenez, Benito
A1 Quilez-Ivorra, Cristina
A1 Vazquez-Moron, Juan Maria
A1 Maria-Huguet, Jose
A1 Gonzalez-Lama, Yago
A1 Muñagorri-Santos, Ana Isabel
A1 Amo, Victor Manuel
A1 Martin-Arranz, Maria Dolores
A1 Bermejo, Fernando
A1 Martinez-Cadilla, Jesus
A1 Rubin-de-Celix, Cristina
A1 Fradejas-Salazar, Paola
A1 Lopez-San-Roman, Antonio
A1 Jimenez, Nuria
A1 Garcia-Lopez, Santiago
A1 Figuerola, Anna
A1 Jimenez, Itxaso
A1 Martinez-Cerezo, Francisco Jose
A1 Taxonera, Carlos
A1 Varela, Pilar
A1 de-Francisco, Ruth
A1 Monfort, David
A1 Molina-Arriero, Gema
A1 Hernandez-Camba, Alejandro
A1 Garcia-Alonso, Francisco Javier
A1 Van-Domselaar, Manuel
A1 Pajares-Villarroya, Ramon
A1 Nuñez, Alejandro
A1 Rodriguez-Moranta, Francisco
A1 Marin-Jimenez, Ignacio
A1 Robles-Alonso, Virginia
A1 Martin-Rodriguez, Maria Del Mar
A1 Camo-Monterde, Patricia
A1 Garcia-Tercero, Ivan
A1 Navarro-Llavat, Mercedes
A1 Arias-Garcia, Lara
A1 Hervias-Cruz, Daniel
A1 Sulleiro, Sara
A1 Novella, Cynthia
A1 Vispo, Eugenia
A1 Barreiro-de-Acosta, Manuel
A1 Gisbert, Javier P
K1 Crohn’s disease
K1 Effectiveness
K1 Real-world evidence
K1 Safety
K1 Ustekinumab
K1 Área de Gestión Sanitaria Norte de Almería
K1 Área de Gestión Sanitaria Sur de Sevilla
K1 Área de Gestión Sanitaria Norte de Almería
K1 Área de Gestión Sanitaria Sur de Sevilla
K1 Área de Gestión Sanitaria Sur de Sevilla
AB Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice. A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.
PB Oxford University Press
YR 2022
FD 2022-02-15
LK http://hdl.handle.net/10668/19795
UL http://hdl.handle.net/10668/19795
LA en
NO Chaparro M, Baston-Rey I, Fernández-Salgado E, González García J, Ramos L, Diz-Lois Palomares MT, et al. Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study. Inflamm Bowel Dis. 2022 Nov 2;28(11):1725-1736
DS RISalud
RD Apr 18, 2025