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

Publicated to:Inflammatory Bowel Diseases. 28 (11): 1725-1736 - 2022-11-02 28(11), DOI: 10.1093/ibd/izab357

Authors: Chaparro M; Baston-Rey I; Fernández-Salgado E; González García J; Ramos L; Diz-Lois Palomares MT; Argüelles-Arias F; Iglesias Flores E; Cabello M; Rubio Iturria S; Núñez Ortiz A; Charro M; Ginard D; Dueñas Sadornil C; Merino Ochoa O; Busquets D; Iyo E; Gutiérrez Casbas A; Ramírez de la Piscina P; Boscá-Watts MM; Arroyo M; García MJ; Hinojosa E; Gordillo J; Martínez Montiel P; Velayos Jiménez B; Quílez Ivorra C; Vázquez Morón JM; María Huguet J; González-Lama Y; Muñagorri Santos AI; Amo VM; Martín-Arranz MD; Bermejo F; Martínez Cadilla J; Rubín de Célix C; Fradejas Salazar P; San Román AL; Jiménez N; García López S; Figuerola A; Jiménez I; Martínez Cerezo FJ; Taxonera C; Varela P; de Francisco R; Monfort D; Molina Arriero G; Hernández Camba A; García-Alonso FJ; Van Domselaar M; Pajares Villarroya R; Núñez A; Rodríguez Moranta F; Marín-Jiménez I; Robles Alonso V; Martín Rodríguez MDM; Camo-Monterde P; García Tercero I; Navarro Llavat M; Arias García L; Hervías Cruz D; Sulleiro S; Novella C; Vispo E; Barreiro-de Acosta M; Gisbert JP

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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. This large retrospective study demonstrated the short- and long-term effectiveness and safety of ustekinumab in patients with Crohn’s disease in real-world clinical practice, including those with refractory disease.

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