Artículo
Long-term real-world effectiveness and safety of ustekinumab in Crohn's disease patients: the SUSTAIN study.
Autor/es | Chaparro, María
Bastón Rey, Iria Fernández Salgado, Estela González García, Javier Ramos, Laura Diz Lois, Palomares Argüelles Arias, Federico Gisbert, Javier P. |
Departamento | Universidad de Sevilla. Departamento de Medicina |
Fecha de publicación | 2022 |
Fecha de depósito | 2022-10-04 |
Publicado en |
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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 ... 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. Downloaded from https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izab357/6528818 by Universidad de Sevilla user on 04 October 2022 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 as sociated 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. Lay Summary 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 |
Cita | Chaparro, M., Bastón Rey, I., Fernández Salgado, E., González García, J., Ramos, L., Diz Lois, P.,...,Gisbert, J.P. (2022). Long-term real-world effectiveness and safety of ustekinumab in Crohn's disease patients: the SUSTAIN study.. Inflammatory Bowel Diseases, 40 (20), 115-12. https://doi.org/10.1093/ibd/izab357. |
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