Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN Study

Chaparro, María ; Baston-Rey, Iria ; Fernández-Salgado, Estela ; González García, Javier ; Ramos, Laura ; Diz-Lois Palomares, María Teresa ; Argüelles-Arias, Federico ; Iglesias Flores, Eva ; Cabello, Mercedes ; Rubio Iturria, Saioa ; Núñez Ortiz, Andrea ; Charro, Mara ; Ginard, Daniel ; Dueñas Sadornil, Carmen ; Merino Ochoa, Olga ; Busquets, David ; Iyo, Eduardo ; Gutiérrez Casbas, Ana ; Ramírez de la Piscina, Patricia ; Boscá-Watts, Marta Maia ; Arroyo, Maite ; García, María José ; Hinojosa, Esther ; Gordillo, Jordi ; Martínez Montiel, Pilar ; Velayos Jiménez, Benito ; Quílez Ivorra, Cristina ; Vázquez Morón, Juan María ; María Huguet, José ; González-Lama, Yago ; Muñagorri Santos, Ana Isabel ; Amo, Víctor Manuel ; Martín-Arranz, María Dolores ; Bermejo, Fernando ; Martínez Cadilla, Jesús ; Rubín de Célix, Cristina ; Fradejas Salazar, Paola ; San Román, Antonio López ; Jiménez, Nuria ; García López, Santiago (Universidad de Zaragoza) ; Figuerola, Anna ; Jiménez, Itxaso ; Martínez Cerezo, Francisco José ; Taxonera, Carlos ; Varela, Pilar ; de Francisco, Ruth ; Monfort, David ; Molina Arriero, Gema ; Hernández Camba, Alejandro ; García-Alonso, Francisco Javier ; Van Domselaar, Manuel ; Pajares Villarroya, Ramón ; Núñez, Alejandro ; Rodríguez Moranta, Francisco ; Marín-Jiménez, Ignacio ; Robles Alonso, Virginia ; Martín Rodríguez, María del Mar ; Camo-Monterde, Patricia ; García Tercero, Iván ; Navarro Llavat, Mercedes ; Arias García, Lara ; Hervías Cruz, Daniel ; Sulleiro, Sara ; Novella, Cynthia ; Vispo, Eugenia ; Barreiro-de Acosta, Manuel ; Gisbert, Javier P

Resumen: Background
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.
Methods
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.
Results
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).
Conclusions
Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.

Idioma: Inglés

DOI: 10.1093/ibd/izab357

Año: 2022

Publicado en: INFLAMMATORY BOWEL DISEASES 28, 11 (2022), 1725-1736
ISSN: 1078-0998

Factor impacto JCR: 4.9 (2022)

Categ. JCR: GASTROENTEROLOGY & HEPATOLOGY rank: 28 / 93 = 0.301 (2022) - Q2 - T1

Factor impacto CITESCORE: 10.1 - Medicine (Q1)

Factor impacto SCIMAGO: 1.834 - Immunology and Allergy (Q1) - Gastroenterology (Q1)

Tipo y forma: Artículo (Versión definitiva)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)