%0 Journal Article
%A Chaparro, Maria
%A Baston-Rey, Iria
%A Fernandez-Salgado, Estela
%A Gonzalez-Garcia, Javier
%A Ramos, Laura
%A Diz-Lois Palomares, Maria Teresa
%A Arguelles-Arias, Federico
%A Iglesias-Flores, Eva
%A Cabello, Mercedes
%A Rubio-Iturria, Saioa
%A Nuñez-Ortiz, Andrea
%A Charro, Mara
%A Ginard, Daniel
%A Dueñas-Sadornil, Carmen
%A Merino-Ochoa, Olga
%A Busquets, David
%A Iyo, Eduardo
%A Gutierrez-Casbas, Ana
%A Ramirez-de-la-Piscina, Patricia
%A Bosca-Watts, Marta Maia
%A Arroyo, Maite
%A Garcia, Maria Jose
%A Hinojosa, Esther
%A Gordillo, Jordi
%A Martinez-Montiel, Pilar
%A Velayos-Jimenez, Benito
%A Quilez-Ivorra, Cristina
%A Vazquez-Moron, Juan Maria
%A Maria-Huguet, Jose
%A Gonzalez-Lama, Yago
%A Muñagorri-Santos, Ana Isabel
%A Amo, Victor Manuel
%A Martin-Arranz, Maria Dolores
%A Bermejo, Fernando
%A Martinez-Cadilla, Jesus
%A Rubin-de-Celix, Cristina
%A Fradejas-Salazar, Paola
%A Lopez-San-Roman, Antonio 
%A Jimenez, Nuria
%A Garcia-Lopez, Santiago
%A Figuerola, Anna
%A Jimenez, Itxaso
%A Martinez-Cerezo, Francisco Jose
%A Taxonera, Carlos
%A Varela, Pilar
%A de-Francisco, Ruth
%A Monfort, David
%A Molina-Arriero, Gema
%A Hernandez-Camba, Alejandro
%A Garcia-Alonso, Francisco Javier
%A Van-Domselaar, Manuel
%A Pajares-Villarroya, Ramon
%A Nuñez, Alejandro
%A Rodriguez-Moranta, Francisco
%A Marin-Jimenez, Ignacio
%A Robles-Alonso, Virginia
%A Martin-Rodriguez, Maria Del Mar
%A Camo-Monterde, Patricia
%A Garcia-Tercero, Ivan
%A Navarro-Llavat, Mercedes
%A Arias-Garcia, Lara
%A Hervias-Cruz, Daniel
%A Sulleiro, Sara
%A Novella, Cynthia
%A Vispo, Eugenia
%A Barreiro-de-Acosta, Manuel
%A Gisbert, Javier P
%T Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study.
%D 2022
%U http://hdl.handle.net/10668/19795
%X 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.
%K Crohn’s disease
%K Effectiveness
%K Real-world evidence
%K Safety
%K Ustekinumab
%K Área de Gestión Sanitaria Norte de Almería
%K Área de Gestión Sanitaria Sur de Sevilla
%K Área de Gestión Sanitaria Norte de Almería
%K Área de Gestión Sanitaria Sur de Sevilla
%K Área de Gestión Sanitaria Sur de Sevilla
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