Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients : The SUSTAIN Study
Chaparro, María (Hospital Universitario de la Princesa (Madrid))
Baston-Rey, Iria (Complejo Hospitalario Universitario de Santiago de Compostela)
Fernández-Salgado, Estela (Complejo Hospitalario Universitario de Pontevedra)
González García, Javier (Hospital Público Comarcal la Inmaculada (Almeria))
Ramos López, Laura (Hospital Universitario de Canarias (Tenerife))
Diz-Lois Palomares, María Teresa (Complejo Hospitalario Universitario de A Coruña)
Argüelles-Arias, Federico (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Iglesias Flores, Eva (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Cabello, Mercedes (Hospital Universitario Virgen de Valme (Sevilla, Andalusia))
Rubio Iturria, Saioa (Complejo Hospitalario de Navarra)
Núñez Ortiz, Andrea (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Charro, Mara (Hospital de Barbastro)
Ginard, Daniel (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Dueñas Sadornil, Carmen (Hospital San Pedro de Alcántara)
Merino Ochoa, Olga (Hospital Universitario de Cruces (Barakaldo, País Basc))
Busquets, David (Hospital Universitari de Girona Doctor Josep Trueta)
Iyo, Eduardo (Hospital Comarcal de Inca)
Gutiérrez Casbas, Ana (Hospital General Universitario de Alicante (Alacant, País Valencià))
Ramírez de la Piscina, Patricia (Arabako Unibertsitate Ospitalea (Vitoria, País Basc))
Bosca-Watts, Marta Maia (Hospital Clínic Universitari (València))
Arroyo, Maite (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Garcia, Maria José (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Hinojosa, Esther (Hospital de Manises (València))
Gordillo, Jordi (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Martínez Montiel, Pilar (Hospital Universitario 12 de Octubre (Madrid))
Velayos Jiménez, Benito (Hospital Clínico Universitario de Valladolid)
Quílez Ivorra, Cristina (Hospital Marina Baixa (La Vila Joiosa, Alacant))
Vázquez Morón, Juan María (Hospital Juan Ramón Jiménez (Huelva))
María Huguet, José (Hospital General Universitario de Valencia)
González-Lama, Yago (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Muñagorri Santos, Ana Isabel (Hospital de Donostia (Sant Sebastià, País Basc))
Amo, Víctor Manuel (Hospital Regional Universitario de Málaga)
Martín-Arranz, María Dolores (Hospital Universitario La Paz (Madrid))
Bermejo, Fernando (Hospital Universitario de Fuenlabrada ( Madrid))
Martínez Cadilla, Jesús (Hospital Álvaro Cunqueiro (Vigo))
Rubín de Célix, Cristina (Hospital Universitario de la Princesa (Madrid))
Fradejas Salazar, Paola (Hospital Virgen de la Concha (Zamora))
San Román, Antonio López (Hospital Universitario Ramón y Cajal (Madrid))
Jiménez, Nuria (Hospital General Universitario de Elche)
García López, Santiago (Hospital Universitario Miguel Servet (Saragossa))
Figuerola, Anna (Consorci Hospitalari Provincial de Castelló)
Jiménez, Itxaso (Hospital de Galdakao (Usansolo, Biscaia))
Martínez Cerezo, Francisco José (Hospital Universitari Sant Joan de Reus (Tarragona))
Taxonera, Carlos (Instituto de Investigación del Hospital Clínico San Carlos (Madrid))
Varela, Pilar (Hospital Universitario de Cabueñes (Gijón))
de Francisco, Ruth (Instituto de Investigación Biosanitaria del Principado de Asturias)
Monfort, David (Consorci Sanitari de Terrassa)
Molina Arriero, Gema (Complejo Hospitalario Universitario de Ferrol)
Hernández Camba, Alejandro (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
P. Gisbert, Javier (Hospital Universitario de la Princesa (Madrid))
Van Domselaar, Manuel (Hospital Universitario de Torrejón)
Pajares Villarroya, Ramón (Hospital Universitario Infanta Sofía (San Sebastián de los Reyes))
Núñez, Alejandro (Hospital Clínico Universitario (Salamanca))
Rodríguez Moranta, Francisco (Hospital Universitari de Bellvitge)
Marín-Jiménez, Ignacio (Hospital General Universitario Gregorio Marañón)
Robles Alonso, Virginia (Hospital Universitari Vall d'Hebron)
Martín Rodríguez, María del Mar (Hospital Universitario Virgen de las Nieves (Granada))
Camo-Monterde, Patricia (Hospital Universitario San Jorge)
García Tercero, Iván (Hospital General Universitario Santa Lucía (Cartagena, Múrcia))
Navarro Llavat, Mercedes (Hospital de Sant Joan Despí Moisès Broggi)
Arias García, Lara (Hospital Universitario de Burgos)
Hervías Cruz, Daniel (Hospital General Universitario de Ciudad Real)
Sulleiro, Sara (Janssen Medical Department (Madrid))
Novella, Cynthia (Janssen Medical Department (Madrid))
Vispo, Eugenia (Janssen Medical Department (Madrid))
Barreiro de-Acosta, Manuel
P. Gisbert, Javier (Complejo Hospitalario Universitario de Santiago de Compostela)
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Crohn's disease ; Effectiveness ; Real-world evidence ; Safety ; Ustekinumab
Published in:	Inflammatory Bowel Diseases, Vol. 28 (february 2022) , p. 1725-1736, ISSN 1536-4844

DOI: 10.1093/ibd/izab357
PMID: 35166347

12 p, 2.4 MB

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