PMID- 34968730
OWN - NLM
STAT- MEDLINE
DCOM- 20220928
LR  - 20221109
IS  - 1542-7714 (Electronic)
IS  - 1542-3565 (Linking)
VI  - 20
IP  - 10
DP  - 2022 Oct
TI  - Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With 
      Crohn's Disease in the CELEST Extension Study.
PG  - 2337-2346.e3
LID - S1542-3565(21)01354-9 [pii]
LID - 10.1016/j.cgh.2021.12.030 [doi]
AB  - BACKGROUND & AIMS: The long-term efficacy and safety of upadacitinib was 
      evaluated in an open-label extension (OLE) of a phase II, double-blind, 
      randomized trial of patients with Crohn's disease. METHODS: Patients who 
      completed the 52-week study (CELEST) received upadacitinib in the CELEST OLE as 
      follows: those who had received immediate-release upadacitinib 3, 6, or 12 mg 
      twice daily or 24 mg once daily (QD) received extended-release upadacitinib 15 mg 
      QD and those who had received immediate-release upadacitinib 12 or 24 mg twice 
      daily as rescue therapy received extended-release upadacitinib 30 mg QD. If any 
      patient initiating upadacitinib 15 mg QD in CELEST OLE lost response at or after 
      week 4, the dose was escalated to upadacitinib 30 mg QD (dose-escalated group). 
      Clinical, endoscopic, inflammatory and quality-of-life measures were assessed. 
      RESULTS: A total of 107 CELEST study completers entered CELEST OLE. The 
      proportion of patients with clinical remission 2.8/1.0 was maintained between 
      week 0 and month 30 in all groups (month 30: 15 mg, 61%; 30 mg, 54%; 
      dose-escalation, 55%). Endoscopic response was maintained in all groups (month 
      24: 68%, 67%, and 40%, respectively). The rates of adverse events (AEs), serious 
      AEs, AEs leading to discontinuation, infections, serious infections, herpes 
      zoster, and creatine phosphokinase elevation were higher with upadacitinib 30 mg 
      vs 15 mg. CONCLUSION: Sustained long-term benefit at 30 months and further 
      endoscopic improvements to month 24 were observed in patients with Crohn's 
      disease receiving upadacitinib. Safety over 30 months was consistent with the 
      known safety profile of upadacitinib. CLINICALTRIALS: gov ID no: NCT02782663.
CI  - Copyright (c) 2022 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - D'Haens, Geert
AU  - D'Haens G
AD  - Department of Gastroenterology and Hepatology, Amsterdam University Medical 
      Centers, Amsterdam, Netherlands. Electronic address: g.dhaens@amsterdamumc.nl.
FAU - Panes, Julian
AU  - Panes J
AD  - Inflammatory Bowel Diseases Unit, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, 
      Barcelona, Spain.
FAU - Louis, Edouard
AU  - Louis E
AD  - Department of Gastroenterology, University Hospital CHU of Liege, Liege, Belgium.
FAU - Lacerda, Ana
AU  - Lacerda A
AD  - Global Pharmaceutical Research and Development, AbbVie Inc, North Chicago, 
      Illinois.
FAU - Zhou, Qian
AU  - Zhou Q
AD  - Data and Statistical Sciences, AbbVie Inc, North Chicago, Illinois.
FAU - Liu, John
AU  - Liu J
AD  - Pharmacovigilance and Patient Safety, AbbVie Inc, North Chicago, Ilinois.
FAU - Loftus, Edward V Jr
AU  - Loftus EV Jr
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, 
      Rochester, Minnesota.
LA  - eng
SI  - ClinicalTrials.gov/NCT02782663
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211227
PL  - United States
TA  - Clin Gastroenterol Hepatol
JT  - Clinical gastroenterology and hepatology : the official clinical practice journal 
      of the American Gastroenterological Association
JID - 101160775
RN  - 0 (Heterocyclic Compounds, 3-Ring)
RN  - 4RA0KN46E0 (upadacitinib)
RN  - EC 2.7.3.2 (Creatine Kinase)
SB  - IM
MH  - Creatine Kinase/therapeutic use
MH  - *Crohn Disease/drug therapy
MH  - Double-Blind Method
MH  - Heterocyclic Compounds, 3-Ring/adverse effects
MH  - Humans
MH  - Treatment Outcome
OTO - NOTNLM
OT  - ABT-494
OT  - CDAI
OT  - IBD
OT  - JAK inhibitor
EDAT- 2021/12/31 06:00
MHDA- 2022/09/28 06:00
CRDT- 2021/12/30 20:15
PHST- 2021/10/15 00:00 [received]
PHST- 2021/12/16 00:00 [revised]
PHST- 2021/12/17 00:00 [accepted]
PHST- 2021/12/31 06:00 [pubmed]
PHST- 2022/09/28 06:00 [medline]
PHST- 2021/12/30 20:15 [entrez]
AID - S1542-3565(21)01354-9 [pii]
AID - 10.1016/j.cgh.2021.12.030 [doi]
PST - ppublish
SO  - Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 
      10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.