Real-world long-term effectiveness of ustekinumab in ulcerative colitis: results from a spanish open-label cohort.
Scand J Gastroenterol
; 59(3): 260-268, 2024 Mar.
Article
em En
| MEDLINE
| ID: mdl-37933161
ABSTRACT
OBJECTIVE:
Ustekinumab was recently approved for the treatment of moderate-to-severe ulcerative colitis (UC). Although data from the UNIFI clinical trial are encouraging, real-world data assessing effectiveness and safety are scarce. The aim of this study was to assess the effectiveness, safety and pharmacokinetics of ustekinumab in a large cohort of refractory UC patients.METHODS:
Multicenter observational study of UC patients who received ustekinumab for active disease. The Partial Mayo Score (PMS), endoscopic activity, C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at different time points. Demographic and clinical data, adverse events (AEs) and surgeries were documented.RESULTS:
A total of 108 patients were analyzed from 4 referral Spanish hospitals. The clinical remission rates were 59%, 56.5%, 57% and 69% of patients at weeks 8, 16, 24 and 52, respectively. Normalization of FC was achieved in 39.6%, 41% and 51% at weeks 8, 24 and 52, respectively. CRP normalization was observed in 79%, 75% and 76.5% of patients at weeks 8, 24 and 52, respectively. Fewer previous anti-TNF agents and loss of response to anti-TNF were associated with clinical response and normalization of FC, respectively. AEs were observed in 5 patients, and 9 underwent colectomy. Ustekinumab persistence rates were 91%, 83% and 81% at 24, 48 and 96 weeks, respectively.CONCLUSIONS:
Ustekinumab demonstrated, in the real-world setting, long-term effectiveness and a favorable safety profile in a cohort of refractory UC patients.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Colite Ulcerativa
/
Ustekinumab
Limite:
Humans
Idioma:
En
Revista:
Scand J Gastroenterol
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Espanha