PMID- 33086438
OWN - NLM
STAT- MEDLINE
DCOM- 20210127
LR  - 20231216
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 52
IP  - 11-12
DP  - 2020 Dec
TI  - Ustekinumab is effective and safe for ulcerative colitis through 2 years of 
      maintenance therapy.
PG  - 1658-1675
LID - 10.1111/apt.16119 [doi]
AB  - BACKGROUND: The ongoing UNIFI long-term extension evaluates subcutaneous 
      ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 
      220. AIMS: To assess efficacy (through week 92) and safety (through week 96) 
      during the long-term extension METHODS: Overall, 399 responders to intravenous 
      ustekinumab induction and who were randomised to maintenance therapy were treated 
      in the long-term extension (115 received subcutaneous placebo, 141 received 
      ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). 
      Placebo treatment was discontinued at unblinding after week 44. Partial Mayo 
      scores were collected every 12 weeks and at each dosing visit after unblinding. 
      Safety was evaluated throughout. RESULTS: Among all patients randomised in 
      maintenance, symptomatic remission rates (stool frequency = 0/1; rectal 
      bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w 
      groups, respectively. Among randomised patients treated in the long-term 
      extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, 
      attained symptomatic remission at week 92; >95% of patients in symptomatic 
      remission at week 92 were corticosteroid-free. Both ustekinumab groups maintained 
      efficacy through week 92. From weeks 44 to 96, adverse events (AEs) per hundred 
      patient-years (PY) of follow-up for combined ustekinumab vs placebo were: 255.68 
      vs 267.93; serious AEs, 9.34 vs 12.69; malignancies (including non-melanoma skin 
      cancers), 0.93 vs 1.49; and serious infections, 2.33 vs 2.99. One patient with 
      multiple comorbidities who received one ustekinumab dose after dose adjusting 
      from placebo experienced a fatal cardiac arrest. CONCLUSIONS: The efficacy of 
      ustekinumab in patients with UC was sustained through 92 weeks. No new safety 
      signals were observed (ClinicalTrials.gov number, NCT02407236).
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Panaccione, Remo
AU  - Panaccione R
AUID- ORCID: 0000-0002-5247-940X
AD  - Calgary, AB, Canada.
FAU - Danese, Silvio
AU  - Danese S
AUID- ORCID: 0000-0001-7341-1351
AD  - Milan, Italy.
FAU - Sandborn, William J
AU  - Sandborn WJ
AUID- ORCID: 0000-0002-3314-7960
AD  - La Jolla, CA, USA.
FAU - O'Brien, Christopher D
AU  - O'Brien CD
AD  - Spring House, PA, USA.
FAU - Zhou, Yiying
AU  - Zhou Y
AD  - Spring House, PA, USA.
FAU - Zhang, Hongyan
AU  - Zhang H
AD  - Spring House, PA, USA.
FAU - Adedokun, Omoniyi J
AU  - Adedokun OJ
AUID- ORCID: 0000-0002-7678-3801
AD  - Spring House, PA, USA.
FAU - Tikhonov, Ilia
AU  - Tikhonov I
AD  - Spring House, PA, USA.
FAU - Targan, Stephan
AU  - Targan S
AD  - Los Angeles, CA, USA.
FAU - Abreu, Maria T
AU  - Abreu MT
AD  - Miami, FL, USA.
FAU - Hisamatsu, Tadakazu
AU  - Hisamatsu T
AUID- ORCID: 0000-0002-1178-3536
AD  - Tokyo, Japan.
FAU - Scherl, Ellen J
AU  - Scherl EJ
AD  - New York, NY, USA.
FAU - Leong, Rupert W
AU  - Leong RW
AD  - Concord, NSW, Australia.
FAU - Rowbotham, David S
AU  - Rowbotham DS
AD  - Auckland, New Zealand.
FAU - Arasaradnam, Ramesh P
AU  - Arasaradnam RP
AUID- ORCID: 0000-0002-2231-3062
AD  - Coventry, UK.
FAU - Sands, Bruce E
AU  - Sands BE
AD  - New York, NY, USA.
FAU - Marano, Colleen
AU  - Marano C
AD  - Spring House, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02407236
GR  - P01 DK046763/DK/NIDDK NIH HHS/United States
GR  - P30 DK120515/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20201021
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
EIN - Aliment Pharmacol Ther. 2021 May;53(9):1057-1060. PMID: 33831243
EIN - Aliment Pharmacol Ther. 2021 Nov;54(9):1221-1222. PMID: 34637538
MH  - Adult
MH  - Colitis, Ulcerative/*drug therapy
MH  - Female
MH  - Humans
MH  - Maintenance Chemotherapy
MH  - Male
MH  - Middle Aged
MH  - Remission Induction
MH  - Treatment Outcome
MH  - Ustekinumab/*therapeutic use
PMC - PMC8776399
MID - NIHMS1748848
EDAT- 2020/10/22 06:00
MHDA- 2021/01/28 06:00
PMCR- 2022/01/20
CRDT- 2020/10/21 20:09
PHST- 2020/08/06 00:00 [received]
PHST- 2020/08/11 00:00 [revised]
PHST- 2020/10/03 00:00 [accepted]
PHST- 2020/10/22 06:00 [pubmed]
PHST- 2021/01/28 06:00 [medline]
PHST- 2020/10/21 20:09 [entrez]
PHST- 2022/01/20 00:00 [pmc-release]
AID - 10.1111/apt.16119 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2020 Dec;52(11-12):1658-1675. doi: 10.1111/apt.16119. 
      Epub 2020 Oct 21.