Year 2022 / Volume 114 / Number 5
Original
Ustekinumab in Crohn's disease: real-world outcomes and predictors of response

272-279

DOI: 10.17235/reed.2020.7352/2020

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

Abstract
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.
Share Button
New comment
Comments
No comments for this article
References
1. Papamichael K, Gils A, Rutgeerts P, et al. Role for therapeutic drug monitoring during induction therapy with TNF antagonists in IBD: evolution in the definition and management of primary nonresponse. Inflamm Bowel Dis 2015;21(1):182-97.
2. Gisbert JP, Panés J. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: a review. Am J Gastroenterol 2009;104(3):760-7.
3. Assessment report Stelara [Internet]. [citado 11 junio 2020]. Disponible en: https://www.ema.europa.eu/en/documents/variation-report/stelara-h-c-000958-x-0049-g-epar-assessment-report-extension_en.pdf
4. Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med 2016;375(20):1946-60.
5. Biemans VBC, van der Meulen-de Jong AE, van der Woude CJ, et al. Ustekinumab for Crohn’s Disease: Results of the ICC Registry, a Nationwide Prospective Observational Cohort Study. J Crohns Colitis 2020;14(1):33-45.
6. Iborra M, Beltrán B, Fernández-Clotet A, et al. Real-world long-term effectiveness of ustekinumab in Crohn’s disease: results from the ENEIDA registry. Aliment Pharmacol Ther 2020;52(6):1017-30.
7. Iborra M, Beltrán B, Fernández-Clotet A, et al. Real-world short-term effectiveness of ustekinumab in 305 patients with Crohn’s disease: results from the ENEIDA registry. Aliment Pharmacol Ther 2019;50(3):278-88.
8. Verstockt B, Ferrante M, Vermeire S, et al. New treatment options for inflammatory bowel diseases. J Gastroenterol 2018;53(5):585-90.
9. Qiu Y, Chen B-L, Mao R, et al. Systematic review with meta-analysis: loss of response and requirement of anti-TNFα dose intensification in Crohn’s disease. J Gastroenterol 2017;52(5):535-54.
10. Miyazaki T, Watanabe K, Kojima K, et al. Efficacies and Related Issues of Ustekinumab in Japanese Patients with Crohn’s Disease: A Preliminary Study. Digestion 2020;101(1):53-9.
11. Macaluso FS, Maida M, Ventimiglia M, et al. Effectiveness and safety of Ustekinumab for the treatment of Crohn’s disease in real-life experiences: a meta-analysis of observational studies. Expert Opin Biol Ther 2020;20(2):193-203.
12. Kubesch A, Rueter L, Farrag K, et al. Short and Long-Term Effectiveness of Ustekinumab in Patients with Crohn’s Disease: Real-World Data from a German IBD Cohort. J Clin Med [Internet] 2019 [citado 20 agosto 2020];8(12). Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6947251/
13. Hoffmann P, Krisam J, Wehling C, et al. Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease. World J Gastroenterol 2019;25(31):4481-92.
14. Moran GW, Dubeau M-F, Kaplan GG, et al. Phenotypic features of Crohn’s disease associated with failure of medical treatment. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc 2014;12(3):434-42.e1.
15. Lopetuso LR, Gerardi V, Papa V, et al. Can We Predict the Efficacy of Anti-TNF-α Agents? Int J Mol Sci 2017;18(9).
16. Barré A, Colombel J-F, Ungaro R. Review article: predictors of response to vedolizumab and ustekinumab in inflammatory bowel disease. Aliment Pharmacol Ther 2018;47(7):896-905.
17. Hoffmann P, Krisam J, Wehling C, et al. Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease. World J Gastroenterol 2019;25(31):4481-92.
18. Greenup A-J, Rosenfeld G, Bressler B. Ustekinumab use in Crohn’s disease: a Canadian tertiary care centre experience. Scand J Gastroenterol 2017;52(12):1354-9.
19. Liefferinckx C, Verstockt B, Gils A, et al. Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn’s Disease Who Failed Biologic Therapies: A National Cohort Study. J Crohns Colitis 2019;13(11):1401-9.
Related articles

Letter

Hepatosplenic T-cell lymphoma and inflammatory bowel disease

DOI: 10.17235/reed.2023.9472/2023

Letter

Isolated Jejunal Crohn's Disease: a challenging diagnosis

DOI: 10.17235/reed.2022.9423/2022

Letter

Comb sign in Crohn’s disease

DOI: 10.17235/reed.2022.9132/2022

Letter

Ectopic ACTH syndrome in a patient with Crohn’s disease

DOI: 10.17235/reed.2022.8825/2022

Review

Clinical settings with tofacitinib in ulcerative colitis

DOI: 10.17235/reed.2022.8660/2022

Letter

Pulmonary nodules in a patient with Crohn’s disease

DOI: 10.17235/reed.2022.8499/2021

Letter

Experience with ustekinumab in reservoir Crohn's disease

DOI: 10.17235/reed.2021.8457/2021

Letter

Anal neoplasia and perianal Crohn’s disease: myth or reality?

DOI: 10.17235/reed.2021.8317/2021

Letter

Apoptotic colopathy as a manifestation of Good’s syndrome

DOI: 10.17235/reed.2021.8297/2021

Original

Radon exposure and inflammatory bowel disease in a radon prone area

DOI: 10.17235/reed.2021.8239/2021

Letter

Adenocarcinoma of the small intestine in Crohn's disease

DOI: 10.17235/reed.2021.8050/2021

Review

Inflammatory bowel disease and solid organ transplantation

DOI: 10.17235/reed.2020.7361/2020

Editorial

Is celiac disease really associated with inflammatory bowel disease?

DOI: 10.17235/reed.2019.6779/2019

Original

Megacolon in inflammatory bowel disease: response to infliximab

DOI: 10.17235/reed.2020.6394/2019

Editorial

Diet in the etiology of inflammatory bowel disease

DOI: 10.17235/reed.2018.6119/2018

Case Report

Serrated Lesions in patients with Inflammatory Bowel Disease.

DOI: 10.17235/reed.2019.5910/2018

Editorial

Online social networks and inflammatory bowel disease

DOI: 10.17235/reed.2018.5496/2018

Letter to the Editor

Idiopathic portal hypertension with regard to thiopurine treatment

DOI: 10.17235/reed.2018.5256/2017

Editorial

Specialist care in the management of inflammatory bowel disease

DOI: 10.17235/reed.2016.4628/2016

Citation tools
Lorenzo González L, Valdés Delgado T, Vázquez Morón J, Castro Laria L, Leo Carnerero E, Maldonado Pérez M, et all. Ustekinumab in Crohn's disease: real-world outcomes and predictors of response. 7352/2020


Download to a citation manager

Download the citation for this article by clicking on one of the following citation managers:

Metrics
This article has received 2127 visits.
This article has been downloaded 374 times.

Statistics from Dimensions


Statistics from Plum Analytics

Publication history

Received: 17/06/2020

Accepted: 27/11/2020

Online First: 04/01/2021

Published: 06/05/2022

Article revision time: 144 days

Article Online First time: 201 days

Article editing time: 688 days


Share
This article hasn't been rated yet.
Reader rating:
Valora este artículo:




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
Cookie policy Privacy Policy Legal Notice © Copyright 2023 y Creative Commons. The Spanish Journal of Gastroenterology