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Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry
- Source :
- JOURNAL OF CROHNS & COLITIS, r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, instname, Dipòsit Digital de la UB, Universidad de Barcelona, Journal of Crohn's & Colitis, Journal of Crohn's & colitis, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, Journal of Crohns & Colitis, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, r-FIHGUV. Repositorio Institucional de Producción Científica de la Fundación de Investigación del Hospital General de Valencia, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol
- Publication Year :
- 2021
- Publisher :
- OXFORD UNIV PRESS, 2021.
-
Abstract
- Background and Aims The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life. Methods Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16. Results A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusions Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.
- Subjects :
- Male
medicine.medical_specialty
ustekinumab
Vedolizumab
03 medical and health sciences
0302 clinical medicine
remission
Colitis ulcerosa
Internal medicine
Ustekinumab
Humans
Medicine
Prospective Studies
Registries
Infusions, Intravenous
Adverse effect
real-world evidence
AcademicSubjects/MED00260
ulcerative colitis
Tofacitinib
response
biology
business.industry
Remission Induction
C-reactive protein
Gastroenterology
General Medicine
Middle Aged
medicine.disease
Ulcerative colitis
Discontinuation
030220 oncology & carcinogenesis
Cohort
biology.protein
durability
Original Article
Colitis, Ulcerative
Female
Monoclonal antibodies
030211 gastroenterology & hepatology
business
Anticossos monoclonals
medicine.drug
Subjects
Details
- ISSN :
- 18739946 and 18764479
- Database :
- OpenAIRE
- Journal :
- JOURNAL OF CROHNS & COLITIS, r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, instname, Dipòsit Digital de la UB, Universidad de Barcelona, Journal of Crohn's & Colitis, Journal of Crohn's & colitis, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, Journal of Crohns & Colitis, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, r-FIHGUV. Repositorio Institucional de Producción Científica de la Fundación de Investigación del Hospital General de Valencia, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol
- Accession number :
- edsair.doi.dedup.....5f7b2051ffa15d7d05e73f628a1f4f30