PMID- 37933161
OWN - NLM
STAT- MEDLINE
DCOM- 20240228
LR  - 20240228
IS  - 1502-7708 (Electronic)
IS  - 0036-5521 (Linking)
VI  - 59
IP  - 3
DP  - 2024 Mar
TI  - Real-world long-term effectiveness of ustekinumab in ulcerative colitis: results 
      from a spanish open-label cohort.
PG  - 260-268
LID - 10.1080/00365521.2023.2278427 [doi]
AB  - 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.
FAU - Iborra, Marisa
AU  - Iborra M
AD  - Inflammatory Bowel Disease Unit, Gastroenterology Department, La Fe University 
      and Polytechnic Hospital, Valencia, Spain.
FAU - Ferreiro-Iglesias, Rocio
AU  - Ferreiro-Iglesias R
AD  - Gastroenterology, Hospital Clinico Universitario de Santiago de Compostela, 
      Santiago de Compostela, Spain.
FAU - Maria Dolores, Martin-Arranz
AU  - Maria Dolores MA
AD  - Instituto de Investigacion Sanitaria del Hospital Universitario La Paz - IdiPAZ, 
      Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Mesonero Gismero, Francisco
AU  - Mesonero Gismero F
AD  - Gastroenterology, Hospital Universitario Ramon y Cajal, Madrid, Madrid, Spain.
FAU - Minguez, Alejandro
AU  - Minguez A
AD  - Inflammatory Bowel Disease Unit, Gastroenterology Department, La Fe University 
      and Polytechnic Hospital, Valencia, Spain.
FAU - Porto-Silva, Sol
AU  - Porto-Silva S
AD  - Gastroenterology, Hospital Clinico Universitario de Santiago de Compostela, 
      Santiago de Compostela, Spain.
FAU - Garcia-Ramirez, Laura
AU  - Garcia-Ramirez L
AD  - Fundacion para la Investigacion Biomedica, Instituto de Investigacion Sanitaria 
      del Hospital Universitario La Paz - IdiPAZ, Madrid, Spain.
FAU - Garcia de la Filia, Irene
AU  - Garcia de la Filia I
AD  - Gastroenterology, Hospital Universitario Ramon y Cajal, Madrid, Madrid, Spain.
FAU - Aguas, Mariam
AU  - Aguas M
AD  - Inflammatory Bowel Disease Unit, Gastroenterology Department, La Fe University 
      and Polytechnic Hospital, Valencia, Spain.
FAU - Nieto-Garcia, Laura
AU  - Nieto-Garcia L
AD  - Gastroenterology, Hospital Clinico Universitario de Santiago de Compostela, 
      Santiago de Compostela, Spain.
FAU - Suarez Ferrer, Cristina
AU  - Suarez Ferrer C
AD  - Instituto de Investigacion Sanitaria del Hospital Universitario La Paz - IdiPAZ, 
      Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Bastida, Guillermo
AU  - Bastida G
AD  - Inflammatory Bowel Disease Unit, Gastroenterology Department, La Fe University 
      and Polytechnic Hospital, Valencia, Spain.
FAU - Barreiro-De-Acosta, Manuel
AU  - Barreiro-De-Acosta M
AD  - Gastroenterology, Hospital Clinico Universitario de Santiago de Compostela, 
      Santiago de Compostela, Spain.
FAU - Nos, Pilar
AU  - Nos P
AD  - Inflammatory Bowel Disease Unit, Gastroenterology Department, La Fe University 
      and Polytechnic Hospital, Valencia, Spain.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20231106
PL  - England
TA  - Scand J Gastroenterol
JT  - Scandinavian journal of gastroenterology
JID - 0060105
RN  - FU77B4U5Z0 (Ustekinumab)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 9007-41-4 (C-Reactive Protein)
SB  - IM
MH  - Humans
MH  - *Ustekinumab/therapeutic use
MH  - *Colitis, Ulcerative/surgery
MH  - Tumor Necrosis Factor Inhibitors/therapeutic use
MH  - Treatment Outcome
MH  - Remission Induction
MH  - C-Reactive Protein
OTO - NOTNLM
OT  - Ustekinumab
OT  - inflammatory bowel disease
OT  - long-term
OT  - real-world
OT  - ulcerative colitis
EDAT- 2023/11/07 06:46
MHDA- 2024/02/28 06:44
CRDT- 2023/11/07 03:40
PHST- 2024/02/28 06:44 [medline]
PHST- 2023/11/07 06:46 [pubmed]
PHST- 2023/11/07 03:40 [entrez]
AID - 10.1080/00365521.2023.2278427 [doi]
PST - ppublish
SO  - Scand J Gastroenterol. 2024 Mar;59(3):260-268. doi: 
      10.1080/00365521.2023.2278427. Epub 2023 Nov 6.