dc.creator | Chaparro, María | es |
dc.creator | Bastón Rey, Iria | es |
dc.creator | Fernández Salgado, Estela | es |
dc.creator | González García, Javier | es |
dc.creator | Ramos, Laura | es |
dc.creator | Diz Lois, Palomares | es |
dc.creator | Argüelles Arias, Federico | es |
dc.creator | Gisbert, Javier P. | es |
dc.date.accessioned | 2022-10-04T14:21:09Z | |
dc.date.available | 2022-10-04T14:21:09Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | 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. | |
dc.identifier.issn | 1078-0998 | es |
dc.identifier.issn | 1536-4844 | es |
dc.identifier.uri | https://hdl.handle.net/11441/137607 | |
dc.description.abstract | 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. | es |
dc.description.abstract | 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 | es |
dc.format | application/pdf | es |
dc.format.extent | 12 p. | es |
dc.language.iso | eng | es |
dc.publisher | Oxford University Press | es |
dc.relation.ispartof | Inflammatory Bowel Diseases, 40 (20), 115-12. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Crohn’s disease | es |
dc.subject | Effectiveness | es |
dc.subject | Real-world evidence | es |
dc.subject | Safety | es |
dc.subject | Ustekinumab | es |
dc.title | Long-term real-world effectiveness and safety of ustekinumab in Crohn's disease patients: the SUSTAIN study. | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izab357/6528818 | es |
dc.identifier.doi | 10.1093/ibd/izab357 | es |
dc.journaltitle | Inflammatory Bowel Diseases | es |
dc.publication.volumen | 40 | es |
dc.publication.issue | 20 | es |
dc.publication.initialPage | 115 | es |
dc.publication.endPage | 12 | es |