PMID- 37278369
OWN - NLM
STAT- MEDLINE
DCOM- 20230727
LR  - 20230727
IS  - 1440-1746 (Electronic)
IS  - 0815-9319 (Linking)
VI  - 38
IP  - 7
DP  - 2023 Jul
TI  - Safety and efficacy of vedolizumab in pediatric patients with ulcerative colitis: 
      multicenter study in Japan.
PG  - 1107-1115
LID - 10.1111/jgh.16246 [doi]
AB  - BACKGROUND: Vedolizumab (VDZ) is a humanized monoclonal antibody that binds to 
      alpha4beta7 integrin expressed in T-lymphocytes and is gut selective. Few studies have 
      evaluated the safety and efficacy of VDZ in pediatric ulcerative colitis (UC) 
      patients, especially from Asia. METHODS: A longitudinal multicenter retrospective 
      study was conducted at 10 Japanese tertiary medical institutions. Patients aged 
      </=18 years old who received VDZ for UC between January 2019 and July 2021 were 
      enrolled. Information on the clinical characteristics, prior/concomitant 
      treatment, and safety during the observation period was collected. RESULTS: The 
      data obtained from 48 patients (males, n = 30; females, n = 18) were analyzed. 
      The median age at VDZ induction was 14 (range 4-18) years old. VDZ was indicated 
      in 73% of patients as switching from previous biologics due to primary failure, 
      loss of response, and adverse events (AEs) and was the first biologic in 27%. 
      Remission was achieved or maintained at weeks 14, 30, and 54 in 79.2%, 75.0%, and 
      65.8% of patients, respectively. There were no significant differences between 
      the number of previous biologics exposures and VDZ effectiveness. The hematocrit, 
      serum albumin concentrations, and erythrocyte sedimentation rate (ESR) at 
      baseline differed significantly by VDZ effectiveness. Nine AEs, including 
      infusion reaction, were noted in seven (14.3%) patients. There were no severe AEs 
      related to VDZ administration. CONCLUSIONS: VDZ was safe and effective in 
      children with UC. The hematocrit, albumin, and ESR at VDZ initiation might be 
      predictors for VDZ effectiveness. VDZ may be an important option for pediatric 
      patients and can be used as an alternative to immunomodulators.
CI  - (c) 2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley & 
      Sons Australia, Ltd.
FAU - Yokoyama, Koji
AU  - Yokoyama K
AUID- ORCID: 0000-0002-7794-7249
AD  - Department of Pediatrics, Jichi Medical University School of Medicine, Tochigi, 
      Japan.
FAU - Yamamoto, Yoko
AU  - Yamamoto Y
AD  - Division of Gastroenterology, National Center for Child Health and Development, 
      Tokyo, Japan.
FAU - Nambu, Ryusuke
AU  - Nambu R
AUID- ORCID: 0000-0002-7206-7111
AD  - Division of Gastroenterology and Hepatology, Saitama Children's Medical Center, 
      Saitama, Japan.
FAU - Hagiwara, Shin-Ichiro
AU  - Hagiwara SI
AD  - Department of Gastroenterology and Endocrinology, Osaka Women's and Children's 
      Hospital, Osaka, Japan.
FAU - Abukawa, Daiki
AU  - Abukawa D
AD  - Department of Gastroenterology and Hepatology, Miyagi Children's Hospital, 
      Sendai, Japan.
FAU - Mizuochi, Tatsuki
AU  - Mizuochi T
AUID- ORCID: 0000-0002-2943-7068
AD  - Department of Pediatrics and Child Health, Kurume University School of Medicine, 
      Kurume, Japan.
FAU - Kudo, Takahiro
AU  - Kudo T
AUID- ORCID: 0000-0003-4708-8049
AD  - Department of Pediatrics, Juntendo University Faculty of Medicine, Tokyo, Japan.
FAU - Sado, Tomomitsu
AU  - Sado T
AD  - Department of Pediatrics, Shinshu University School of Medicine, Matsumoto, 
      Japan.
FAU - Iwata, Naomi
AU  - Iwata N
AD  - Division of Infectious Disease and Immunology, Aichi Children's Health and 
      Medical Center, Obu, Japan.
FAU - Ishige, Takashi
AU  - Ishige T
AD  - Department of Pediatrics, Gunma University Graduate School of Medicine, Maebashi, 
      Japan.
FAU - Iwama, Itaru
AU  - Iwama I
AUID- ORCID: 0000-0001-8677-8195
AD  - Division of Gastroenterology and Hepatology, Saitama Children's Medical Center, 
      Saitama, Japan.
FAU - Kumagai, Hideki
AU  - Kumagai H
AD  - Department of Pediatrics, Jichi Medical University School of Medicine, Tochigi, 
      Japan.
FAU - Arai, Katsuhiro
AU  - Arai K
AUID- ORCID: 0000-0002-6440-4640
AD  - Division of Gastroenterology, National Center for Child Health and Development, 
      Tokyo, Japan.
FAU - Shimizu, Toshiaki
AU  - Shimizu T
AD  - Department of Pediatrics, Juntendo University Faculty of Medicine, Tokyo, Japan.
LA  - eng
GR  - Japanese Society for Pediatric Inflammatory Bowel Disease/
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230606
PL  - Australia
TA  - J Gastroenterol Hepatol
JT  - Journal of gastroenterology and hepatology
JID - 8607909
RN  - 9RV78Q2002 (vedolizumab)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Biological Factors)
RN  - 0 (Biological Products)
SB  - IM
MH  - Male
MH  - Female
MH  - Humans
MH  - Child
MH  - Child, Preschool
MH  - Adolescent
MH  - *Colitis, Ulcerative/drug therapy
MH  - Retrospective Studies
MH  - Japan
MH  - Gastrointestinal Agents/adverse effects
MH  - Biological Factors/therapeutic use
MH  - *Biological Products/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - biologics
OT  - children
OT  - inflammatory bowel disease
OT  - ulcerative colitis
OT  - vedolizumab
EDAT- 2023/06/06 13:10
MHDA- 2023/07/27 06:42
CRDT- 2023/06/06 07:33
PHST- 2023/05/20 00:00 [revised]
PHST- 2023/01/06 00:00 [received]
PHST- 2023/05/20 00:00 [accepted]
PHST- 2023/07/27 06:42 [medline]
PHST- 2023/06/06 13:10 [pubmed]
PHST- 2023/06/06 07:33 [entrez]
AID - 10.1111/jgh.16246 [doi]
PST - ppublish
SO  - J Gastroenterol Hepatol. 2023 Jul;38(7):1107-1115. doi: 10.1111/jgh.16246. Epub 
      2023 Jun 6.