PMID- 32445049
OWN - NLM
STAT- MEDLINE
DCOM- 20210830
LR  - 20210830
IS  - 1573-2568 (Electronic)
IS  - 0163-2116 (Linking)
VI  - 66
IP  - 5
DP  - 2021 May
TI  - Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of 
      Randomized Controlled Trials.
PG  - 1631-1638
LID - 10.1007/s10620-020-06344-w [doi]
AB  - GOALS AND BACKGROUND: Ustekinumab (UST) is a monoclonal antibody inhibitor of 
      IL-12/IL-23 approved for the treatment of Crohn's disease (CD) and ulcerative 
      colitis (UC). We conducted a meta-analysis to compare rates of adverse events 
      (AEs) in randomized controlled trials (RCTs) of UST for all indications. STUDY: A 
      systematic search was performed of MEDLINE, Embase, and PubMed databases through 
      November 2019. Study inclusion included RCTs comparing UST to placebo or other 
      biologics in patients aged 18 years or older with a diagnosis of an autoimmune 
      condition. RESULTS: Thirty RCTs with 16,068 patients were included in our 
      analysis. Nine thousand six hundred and twenty-six subjects were included in the 
      UST vs placebo analysis. There was no significant difference in serious or 
      mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) 
      and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 
      16 weeks. In a sub-analysis of CD and UC trials, no difference in serious or 
      mild/moderate AEs in UST versus placebo was seen. CONCLUSIONS: UST was not 
      associated with an increase in short-term risk of AEs.
FAU - Rolston, Vineet S
AU  - Rolston VS
AUID- ORCID: 0000-0001-7975-8508
AD  - Division of Gastroenterology, NYU School of Medicine, New York, NY, USA.
FAU - Kimmel, Jessica
AU  - Kimmel J
AD  - Division of Gastroenterology, NYU School of Medicine, New York, NY, USA.
FAU - Popov, Violeta
AU  - Popov V
AD  - Division of Gastroenterology, NYU School of Medicine, New York, NY, USA.
AD  - Division of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd 
      Floor, New York, NY, 10016, USA.
FAU - Bosworth, Brian P
AU  - Bosworth BP
AD  - Division of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd 
      Floor, New York, NY, 10016, USA.
FAU - Hudesman, David
AU  - Hudesman D
AD  - Division of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd 
      Floor, New York, NY, 10016, USA.
FAU - Malter, Lisa B
AU  - Malter LB
AD  - Division of Gastroenterology, NYU School of Medicine, New York, NY, USA.
FAU - Hong, Simon
AU  - Hong S
AD  - Division of Gastroenterology, NYU School of Medicine, New York, NY, USA.
FAU - Chang, Shannon
AU  - Chang S
AD  - Division of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd 
      Floor, New York, NY, 10016, USA. Shannon.Chang@nyumc.org.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20200522
PL  - United States
TA  - Dig Dis Sci
JT  - Digestive diseases and sciences
JID - 7902782
RN  - 0 (Immunosuppressive Agents)
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
MH  - Adult
MH  - Colitis, Ulcerative/diagnosis/*drug therapy/immunology
MH  - Crohn Disease/diagnosis/*drug therapy/immunology
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ustekinumab/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Crohn's disease
OT  - Inflammatory bowel disease
OT  - Ulcerative colitis
OT  - Ustekinumab
EDAT- 2020/05/24 06:00
MHDA- 2021/08/31 06:00
CRDT- 2020/05/24 06:00
PHST- 2019/05/07 00:00 [received]
PHST- 2020/05/12 00:00 [accepted]
PHST- 2020/05/24 06:00 [pubmed]
PHST- 2021/08/31 06:00 [medline]
PHST- 2020/05/24 06:00 [entrez]
AID - 10.1007/s10620-020-06344-w [pii]
AID - 10.1007/s10620-020-06344-w [doi]
PST - ppublish
SO  - Dig Dis Sci. 2021 May;66(5):1631-1638. doi: 10.1007/s10620-020-06344-w. Epub 2020 
      May 22.