Year 2022 / Volume 114 / Number 5
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Year 2022 / Volume 114 / Number 5

Original

Ustekinumab in Crohn's disease: real-world outcomes and predictors of response

272-279

Laura Lorenzo González, Teresa Valdés Delgado, Juan María Vázquez Morón, Luisa Castro Laria, Eduardo Leo Carnerero, María Belén Maldonado Pérez, Damián Sánchez Capilla, Héctor Pallarés Manrique, Antonia Sáez Díaz, Federico Argüelles Arias, Laura Lorenzo González on behalf of Grupo de Enfermedad Inflamatoria de Andalucía *,

* Grupo de Enfermedad Inflamatoria de Andalucía : Laura Lorenzo González, Teresa Valdés Delgado, Juan María Vázquez Morón, Luisa Castro Laria, Eduardo Leo Carnerero, María Belén Maldonado Pérez, Damián Sánchez Capilla, Héctor Pallarés Manrique, Federico Argüelles-Arias

Background: ustekinumab is a monoclonal antibody that inhibits interleukins IL-12 and IL-23, and is approved for the treatment of Crohn's disease (CD) and, more recently, also ulcerative colitis (UC). The aim of this study was to evaluate the effectiveness and safety of ustekinumab, as well as to identify possible predictive factors of response in a real-life setting. Methods: an observational, retrospective, multicenter study was carried out in 4 hospitals in Andalusia. Adult patients with a confirmed diagnosis of CD treated with ustekinumab from 2017 to 2019 were included. Clinical response was analyzed at 3, 6 and 12 months of treatment. Clinical disease activity was assessed with the Harvey-Bradshaw index (HBI) and the Crohn's Disease Activity Index (CDAI); biochemical response was assessed with lab parameters such as CRP and ESR. One-year ustekinumab drug-survival was analyzed. Results: a total of 98 patients were analyzed (mean age, 43 years; 52 % were male); 56 % had failed with ≥ 2 previous biologicals therapies. At 3 months, 69 % of the patients were in response and 40.8 % in remission. At 6 months, 56 % were in clinical remission. At 12 months, 73.7 % were in clinical response and 60.5 % in remission. Corticosteroid-free remission was 32.4 %, 44 %, and 47.4 % at 3, 6, and 12 months, respectively. Cumulative survival after one year of treatment with ustekinumab was 85.3 %. Biochemical parameters such as CRP and ESR showed a statistically significant decrease between baseline and control levels at 3, 6, and 12 months. A lower HBI at baseline and female sex were predictors of corticosteroid-free clinical remission in a univariate analysis. In the multivariate analysis no variables were found as predictors of corticosteroid-free clinical remission. Conclusion: ustekinumab therapy is safe and useful, inducing clinical response in more than 50 % of patients, including patients who failed with other biological therapies.

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Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
The Spanish Journal of Gastroenterology is the official organ of the Sociedad Española de Patología Digestiva, the Sociedad Española de Endoscopia Digestiva and the Asociación Española de Ecografía Digestiva
© 2022 The Spanish Journal of Gastroenterology