dc.creator | Valdes Delgado, Teresa | es |
dc.creator | Olmedo Martín, Raúl | es |
dc.creator | Iborra, Marisa | es |
dc.creator | Herrera de Guise, Claudia | es |
dc.creator | Fuentes-Valenzuela, Esteban | es |
dc.creator | Melcarne, Luigi | es |
dc.creator | Argüelles Arias, Federico | es |
dc.date.accessioned | 2023-09-22T13:37:24Z | |
dc.date.available | 2023-09-22T13:37:24Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Valdes Delgado, T., Olmedo Martín, R., Iborra, M., Herrera de Guise, C., Fuentes-Valenzuela, E., Melcarne, L. y Argüelles Arias, F. (2023). Effectiveness and safety of ustekinumab in bio-naive Crohn's disease patients: a multicentre observational retrospective study. Therapeutic Advances in Gastroenterology, 16, 1-13. https://doi.org/10.1177/17562848231153560. | |
dc.identifier.issn | 1756-283X | es |
dc.identifier.uri | https://hdl.handle.net/11441/149118 | |
dc.description.abstract | Background: Clinical trials have demonstrated the efficacy and safety of ustekinumab in
Crohn’s disease (CD). However, more data are necessary on the effectiveness of ustekinumab
in bio-naïve patients in real-life studies.
Objectives: The aim of our study was to evaluate the effectiveness and safety of ustekinumab
in patients with CD refractory or intolerant to conventional therapy and without previous
exposure to biological drugs.
Design: We performed a nationwide, observational, retrospective, multicentre study including
patients with CD, in which ustekinumab was used as the first biological drug.
Methods: The corticosteroid-free clinical and biological response and remission were
analysed at weeks 16, 24, 52 and 72. Clinical remission was defined as Harvey–Bradshaw
index⩽4 and biological remission as a faecal calprotectin (FC) <250mg/g and C-reactive
protein (CRP) <5mg/L. Moreover, the persistence of the treatment and any adverse events
were assessed.
Results: In all, 84 patients were included in the study, males and females were equally
distributed, with a median age of 63years [interquartile range (IQR): 51–75] and a median
disease duration of 6.8years [IQR: 3.6–17.0]. The majority (86.9%) of patients were treated
with ustekinumab as monotherapy, without concomitant immunosuppressive medication. The
proportion of patients in corticosteroid-free clinical remission or response at weeks 16, 24, 52
and 72 was 93.3% (56/60), 86.8% (46/53), 82.2% (37/45) and 71.4% (30/42), respectively. CRP
returned to normal values in 47.6%, 43.2%, 50% and 52.4% of patients at weeks 16, 24, 52 and
72, respectively. Similarly, FC was normalized in 45.5%, 45.5%, 48.6% and 50% of patients at
weeks 16, 24, 52 and 72, respectively. The cumulative probability of remaining on ustekinumab
treatment was 84.8% (95% confidence interval: 73.3–91.6) after 72weeks. Ustekinumab was
discontinued in 10 patients (11.9%) within 72weeks of follow-up. Reasons for discontinuing
treatment were lack of response (n=4), adverse events (n=4) and death (n=2). There were no
discontinuations because of stable remission.
Conclusions: Ustekinumab was effective and safe in Spanish bio-naïve CD patients, showing
a quicker and more durable response than obtained in patients with previous biological
treatment. In this cohort of bio-naïve patients starting on ustekinumab, the average age was
high. | es |
dc.format | application/pdf | es |
dc.format.extent | 13 p. | es |
dc.language.iso | eng | es |
dc.publisher | SAGE Publishing | es |
dc.relation.ispartof | Therapeutic Advances in Gastroenterology, 16, 1-13. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Biological therapy | es |
dc.subject | Bio-naïve | es |
dc.subject | Crohn’s disease | es |
dc.subject | Effectiveness | es |
dc.subject | Ustekinumab | es |
dc.title | Effectiveness and safety of ustekinumab in bio-naive Crohn's disease patients: a multicentre observational retrospective 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://journals.sagepub.com/doi/10.1177/17562848231153560 | es |
dc.identifier.doi | 10.1177/17562848231153560 | es |
dc.journaltitle | Therapeutic Advances in Gastroenterology | es |
dc.publication.volumen | 16 | es |
dc.publication.initialPage | 1 | es |
dc.publication.endPage | 13 | es |