PMID- 32770851
OWN - NLM
STAT- MEDLINE
DCOM- 20210112
LR  - 20210112
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 52
IP  - 6
DP  - 2020 Sep
TI  - Real-world long-term effectiveness of ustekinumab in Crohn's disease: results 
      from the ENEIDA registry.
PG  - 1017-1030
LID - 10.1111/apt.15958 [doi]
AB  - BACKGROUND: Data on the long-term administration of ustekinumab in recommended 
      doses are limited. AIM: To assess the real-world, long-term effectiveness of 
      ustekinumab in refractory Crohn's disease (CD). METHODS: Multi-centre study of CD 
      patients starting ustekinumab at the recommended dose, followed for 1 year. 
      Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive 
      protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at 
      weeks 26 and 52. Demographic and clinical data, previous treatments, adverse 
      events (AEs) and hospitalisations were documented. Potential predictors of 
      remission were examined. RESULTS: A total of 407 patients were analysed. The 
      initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 
      56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment 
      was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 
      points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 
      and 52, respectively. FC levels returned to normal in 44% and 54% of patients at 
      weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 
      26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer 
      previous anti-TNFalpha agents and ileal localisation were associated with clinical 
      remission, and endoscopic severity was associated with poor response. No factors 
      correlated with endoscopic remission. CONCLUSION: After 52 weeks, ustekinumab 
      demonstrated effectiveness in inducing clinical and endoscopic remission in 
      patients with refractory CD.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Iborra, Marisa
AU  - Iborra M
AUID- ORCID: 0000-0001-7360-7581
AD  - Valencia, Spain.
FAU - Beltran, Belen
AU  - Beltran B
AD  - Valencia, Spain.
FAU - Fernandez-Clotet, Agnes
AU  - Fernandez-Clotet A
AD  - Barcelona, Spain.
FAU - Iglesias-Flores, Eva
AU  - Iglesias-Flores E
AD  - Cordoba, Spain.
FAU - Navarro, Pablo
AU  - Navarro P
AD  - Valencia, Spain.
FAU - Rivero, Montserrat
AU  - Rivero M
AD  - Santander, Spain.
FAU - Gutierrez, Ana
AU  - Gutierrez A
AD  - Alicante, Spain.
FAU - Sierra-Ausin, Monica
AU  - Sierra-Ausin M
AD  - Leon, Spain.
FAU - Mesonero, Francisco
AU  - Mesonero F
AD  - Madrid, Spain.
FAU - Ferreiro-Iglesias, Rocio
AU  - Ferreiro-Iglesias R
AD  - Santiago de Compostela, Spain.
FAU - Hinojosa, Joaquin
AU  - Hinojosa J
AUID- ORCID: 0000-0002-2157-9328
AD  - Valencia, Spain.
FAU - Calvet, Xavier
AU  - Calvet X
AD  - Barcelona, Spain.
FAU - Sicilia, Beatriz
AU  - Sicilia B
AD  - Burgos, Spain.
FAU - Gonzalez-Munoza, Carlos
AU  - Gonzalez-Munoza C
AD  - Barcelona, Spain.
FAU - Antolin, Beatriz
AU  - Antolin B
AD  - Valladolid, Spain.
FAU - Gonzalez-Vivo, Maria
AU  - Gonzalez-Vivo M
AD  - Barcelona, Spain.
FAU - Carbajo, Ana Y
AU  - Carbajo AY
AD  - Valladolid, Spain.
FAU - Garcia-Lopez, Santiago
AU  - Garcia-Lopez S
AD  - Zaragoza, Spain.
FAU - Martin-Cardona, Albert
AU  - Martin-Cardona A
AUID- ORCID: 0000-0002-7090-0106
AD  - Barcelona, Spain.
FAU - Suris, Gerard
AU  - Suris G
AD  - Barcelona, Spain.
FAU - Martin-Arranz, Maria Dolores
AU  - Martin-Arranz MD
AD  - Madrid, Spain.
FAU - de Francisco, Ruth
AU  - de Francisco R
AD  - Asturias, Spain.
FAU - Canete, Fiorella
AU  - Canete F
AD  - Barcelona, Spain.
FAU - Domenech, Eugeni
AU  - Domenech E
AUID- ORCID: 0000-0002-2315-7196
AD  - Barcelona, Spain.
FAU - Nos, Pilar
AU  - Nos P
AD  - Valencia, Spain.
CN  - GETECCU group (Grupo Espanol de trabajo de Enfermedades de Crohn y Colitis 
      Ulcerosa)
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20200808
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Leukocyte L1 Antigen Complex)
RN  - 0 (TNF protein, human)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
MH  - Adult
MH  - C-Reactive Protein/metabolism
MH  - Crohn Disease/*drug therapy
MH  - Endoscopy
MH  - Female
MH  - Humans
MH  - Ileum/pathology
MH  - Leukocyte L1 Antigen Complex/metabolism
MH  - Male
MH  - Middle Aged
MH  - Registries
MH  - Remission Induction
MH  - Retrospective Studies
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors
MH  - Ustekinumab/*therapeutic use
FIR - Taxonera, C
IR  - Taxonera C
FIR - Gomollon, F
IR  - Gomollon F
FIR - Lorente, R
IR  - Lorente R
FIR - Rodriguez-Lago, I
IR  - Rodriguez-Lago I
FIR - Fores-Bosch, A
IR  - Fores-Bosch A
FIR - Bernardos, E
IR  - Bernardos E
FIR - Ramos, L
IR  - Ramos L
FIR - Delgado-Guillena, P
IR  - Delgado-Guillena P
FIR - Hernandez, A
IR  - Hernandez A
FIR - Van Domselaar, M
IR  - Van Domselaar M
FIR - Hervas, D
IR  - Hervas D
FIR - Casas-Deza, D
IR  - Casas-Deza D
EDAT- 2020/08/10 06:00
MHDA- 2021/01/13 06:00
CRDT- 2020/08/10 06:00
PHST- 2020/03/27 00:00 [received]
PHST- 2020/04/26 00:00 [revised]
PHST- 2020/06/20 00:00 [accepted]
PHST- 2020/08/10 06:00 [pubmed]
PHST- 2021/01/13 06:00 [medline]
PHST- 2020/08/10 06:00 [entrez]
AID - 10.1111/apt.15958 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2020 Sep;52(6):1017-1030. doi: 10.1111/apt.15958. Epub 
      2020 Aug 8.