PMID- 32876349
OWN - NLM
STAT- MEDLINE
DCOM- 20210119
LR  - 20210119
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 52
IP  - 8
DP  - 2020 Oct
TI  - Long-term safety of vedolizumab for inflammatory bowel disease.
PG  - 1353-1365
LID - 10.1111/apt.16060 [doi]
AB  - BACKGROUND: Vedolizumab, a gut-selective alpha(4) beta(7) integrin antibody, is approved 
      for moderately to severely active ulcerative colitis (UC) and Crohn's disease 
      (CD). AIM: To report the final results from the vedolizumab GEMINI long-term 
      safety (LTS) study. METHODS: The phase 3, open-label GEMINI LTS study (initiated 
      May 2009) enrolled patients with UC or CD from four prior clinical trials and 
      vedolizumab-naive patients. Vedolizumab LTS was evaluated; efficacy and 
      patient-reported outcomes were exploratory endpoints. RESULTS: Enrolled patients 
      (UC, n = 894; CD, n = 1349) received vedolizumab 300 mg IV every 4 weeks; median 
      cumulative exposure was 42.4 months (range: 0.03-112.2) for UC and 31.5 months 
      (range: 0.03-100.3) for CD. Over 8 years, adverse events (AEs) occurred in 93% 
      (UC) and 96% (CD) of patients, with UC (36%) and CD (35%) exacerbations most 
      frequent. Serious AEs were reported for 31% (UC) and 41% (CD) of patients. 
      Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of 
      patients. There were no new trends for infections, malignancies, infusion-related 
      reactions, or hepatic events, and no cases of progressive multifocal 
      leukoencephalopathy. Of the ten deaths (UC, n = 4; CD, n = 6), two were 
      considered drug-related by local investigators (West Nile virus infection-related 
      encephalitis and hepatocellular carcinoma). Continuous vedolizumab maintained 
      clinical response long-term, with 33% (UC) and 28% (CD) of patients in clinical 
      remission at 400 treatment weeks. CONCLUSIONS: The safety profile of vedolizumab 
      remains favourable with no unexpected or new safety concerns. These results 
      further establish the safety of vedolizumab and support its long-term use 
      (NCT00790933/EudraCT 2008-002784-14).
CI  - (c) 2020 Takeda Pharmaceuticals USA. Alimentary Pharmacology & Therapeutics 
      published by John Wiley & Sons Ltd.
FAU - Loftus, Edward V Jr
AU  - Loftus EV Jr
AUID- ORCID: 0000-0001-7199-6851
AD  - Rochester, MN, USA.
FAU - Feagan, Brian G
AU  - Feagan BG
AUID- ORCID: 0000-0002-6914-3822
AD  - London, ON, Canada.
FAU - Panaccione, Remo
AU  - Panaccione R
AUID- ORCID: 0000-0002-5247-940X
AD  - Calgary, AB, Canada.
FAU - Colombel, Jean-Frederic
AU  - Colombel JF
AUID- ORCID: 0000-0001-6472-249X
AD  - New York, NY, USA.
FAU - Sandborn, William J
AU  - Sandborn WJ
AUID- ORCID: 0000-0002-3314-7960
AD  - San Diego, CA, USA.
FAU - Sands, Bruce E
AU  - Sands BE
AUID- ORCID: 0000-0001-5762-5042
AD  - New York, NY, USA.
FAU - Danese, Silvio
AU  - Danese S
AUID- ORCID: 0000-0001-7341-1351
AD  - Milan, Italy.
FAU - D'Haens, Geert
AU  - D'Haens G
AUID- ORCID: 0000-0003-2784-4046
AD  - Amsterdam, The Netherlands.
FAU - Rubin, David T
AU  - Rubin DT
AUID- ORCID: 0000-0001-5647-1723
AD  - Chicago, IL, USA.
FAU - Shafran, Ira
AU  - Shafran I
AD  - Winter Park, FL, USA.
FAU - Parfionovas, Andrejus
AU  - Parfionovas A
AD  - Cambridge, MA, USA.
FAU - Rogers, Raquel
AU  - Rogers R
AD  - Cambridge, MA, USA.
FAU - Lirio, Richard A
AU  - Lirio RA
AUID- ORCID: 0000-0001-8342-9942
AD  - Cambridge, MA, USA.
FAU - Vermeire, Severine
AU  - Vermeire S
AUID- ORCID: 0000-0001-9942-3019
AD  - Leuven, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT00790933
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200902
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Gastrointestinal Agents)
RN  - 9RV78Q2002 (vedolizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Cohort Studies
MH  - Colitis, Ulcerative/drug therapy/epidemiology
MH  - Crohn Disease/drug therapy/epidemiology
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Follow-Up Studies
MH  - Gastrointestinal Agents/administration & dosage/adverse effects
MH  - Humans
MH  - Inflammatory Bowel Diseases/*drug therapy/*epidemiology
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7540482
EDAT- 2020/09/03 06:00
MHDA- 2021/01/20 06:00
PMCR- 2020/10/07
CRDT- 2020/09/03 06:00
PHST- 2020/04/10 00:00 [received]
PHST- 2020/04/26 00:00 [revised]
PHST- 2020/08/02 00:00 [accepted]
PHST- 2020/09/03 06:00 [pubmed]
PHST- 2021/01/20 06:00 [medline]
PHST- 2020/09/03 06:00 [entrez]
PHST- 2020/10/07 00:00 [pmc-release]
AID - APT16060 [pii]
AID - 10.1111/apt.16060 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2020 Oct;52(8):1353-1365. doi: 10.1111/apt.16060. Epub 
      2020 Sep 2.