Abstract
Original language | English |
---|---|
Pages (from-to) | 2337-2346.e3 |
Journal | Clinical Gastroenterology and Hepatology |
Volume | 20 |
Issue number | 10 |
Early online date | 2022 |
DOIs | |
Publication status | Published - Oct 2022 |
Keywords
- ABT-494
- CDAI
- IBD
- JAK inhibitor
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In: Clinical Gastroenterology and Hepatology, Vol. 20, No. 10, 10.2022, p. 2337-2346.e3.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study
AU - D'Haens, Geert
AU - Panés, Julian
AU - Louis, Edouard
AU - Lacerda, Ana
AU - Zhou, Qian
AU - Liu, John
AU - Loftus, Edward V.
N1 - Funding Information: Geert R. D'Haens, MD, PhD (Conceptualization: Equal; Formal analysis: Equal; Methodology: Equal; Writing – original draft: Lead; Writing – review & editing: Lead), Julian Panés (Formal analysis: Equal; Methodology: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Edouard Louis (Formal analysis: Equal; Investigation: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Ana Lacerda (Conceptualization: Equal; Data curation: Equal; Formal analysis: Equal; Investigation: Equal; Methodology: Equal; Project administration: Equal; Supervision: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Qian Zhou (Conceptualization: Equal; Data curation: Equal; Formal analysis: Equal; Methodology: Equal; Software: Equal; Supervision: Equal; Validation: Equal; Visualization: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), John Liu (Formal analysis: Equal; Methodology: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Edward V. Loftus Jr (Formal analysis: Equal; Investigation: Equal; Writing – original draft: Equal; Writing – review & editing: Equal) Conflicts of interest The authors disclose the following: Geert D‘Haens has served as advisor for AbbVie, Ablynx, Active Biotech AB, Agomab Therapeutics, Alimentiv, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Myers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, Dr Falk Pharma, DSM Pharma, Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences, Ferring, Galapagos, Genentech/Roche, Gilead, GlaxoSmithKline, Gossamerbio, Immunic, Johnson and Johnson, Kintai Therapeutics, Lument, Lycera, Medimetrics, Medtronic, Mitsubishi Pharma, Merck Sharp & Dohme, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Pfizer, Photopill, ProciseDx, Prodigest, Prometheus Laboratories/Nestle, Progenity, Protagonist, RedHill, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Takeda, Teva, Tigenix, Tillotts, Topivert, Versant, and Vifor; and has received speaker fees from AbbVie, Biogen, Ferring, Galapagos/Gilead, Johnson and Johnson, Merck Sharp & Dohme, Millenium/Takeda, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Tillotts, and Vifor. Julian Panés has served as consultant and/or speaker for AbbVie, Arena, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Genentech, GlaxoSmithKline, Janssen, Origo, Pandion, Pfizer, Progenity, Robarts, Roche, Takeda, Theravance, and Wassermann; and has received research grants from AbbVie and Pfizer. Edouard Louis has received research grants from Janssen, Pfizer, and Takeda; has received educational grants from AbbVie, Janssen, MSD, and Takeda; has received speaker fees from AbbVie, Falk, Ferring, Hospira, Janssen, MSD, Pfizer, and Takeda; has served on advisory boards for AbbVie, Arena, Celgene, Ferring, Galapagos, Gilead, Hospira, Janssen, MSD, Pfizer, and Takeda; and has served as a consultant for AbbVie. Edward V. Loftus Jr has served as a consultant for AbbVie, Allergan, Amgen, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Calibr, Celgene, Celltrion Healthcare, Eli Lilly, Genentech, Gilead, Gossamer Bio, Iterative Scopes, Janssen, Ono Pharma, Pfizer, Scipher Medicine, Sun Pharma, Takeda, and UCB; and has received research grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, Receptos, Robarts Clinical Trials, Takeda, Theravance, and UCB. John Liu, Qian Zhou, and Ana Lacerda are AbbVie employees and may own AbbVie stock and/or options. Funding AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Alan Storey, PhD, and Maria Hovenden, PhD, of ICON (North Wales, PA) and was funded by AbbVie. Funding Information: Funding AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Alan Storey, PhD, and Maria Hovenden, PhD, of ICON (North Wales, PA) and was funded by AbbVie. Publisher Copyright: © 2021 AGA Institute
PY - 2022/10
Y1 - 2022/10
N2 - 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.
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.
KW - ABT-494
KW - CDAI
KW - IBD
KW - JAK inhibitor
UR - http://www.scopus.com/inward/record.url?scp=85124398478&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cgh.2021.12.030
DO - https://doi.org/10.1016/j.cgh.2021.12.030
M3 - Article
C2 - 34968730
SN - 1542-3565
VL - 20
SP - 2337-2346.e3
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 10
ER -