Article (Scientific journals)
Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results.
Panés, Julián; Colombel, Jean-Frederic; D'Haens, Geert R et al.
2022In Gastroenterology, 162 (7), p. 1891-1910
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Keywords :
FYS6T7F842 (Adalimumab); Adalimumab/therapeutic use; Clinical Protocols; Colitis, Ulcerative/chemically induced/diagnosis/drug therapy; Double-Blind Method; Humans; Remission Induction; Treatment Outcome; Adalimumab; Clinical Trial Result; Inflammatory Bowel Disease; Moderately to Severely Active Ulcerative Colitis; Monoclonal Antibody
Abstract :
[en] BACKGROUND & AIMS: SERENE UC (Study of a Novel Approach to Induction and Maintenance Dosing With Adalimumab in Patients With Moderate to Severe Ulcerative Colitis) evaluated the efficacy of higher adalimumab induction and maintenance dose regimens in patients with ulcerative colitis. METHODS: This phase 3, double-blind, randomized trial included induction and maintenance studies, with a main study (ex-Japan) and Japan substudy. Eligible patients (18-75 years, full Mayo score 6-12, centrally read endoscopy subscore 2-3) were randomized 3:2 to higher induction regimen (adalimumab 160 mg at weeks 0, 1, 2, and 3) or standard induction regimen (160 mg at week 0 and 80 mg at week 2); all received 40 mg at weeks 4 and 6. At week 8, all patients were rerandomized 2:2:1 (main study) to 40 mg every week (ew), 40 mg every other week (eow), or exploratory therapeutic drug monitoring; or 1:1 (Japan substudy) to 40 mg ew or 40 mg eow maintenance regimens. RESULTS: In the main study, 13.3% vs 10.9% of patients receiving the higher induction regimen vs standard induction regimen achieved clinical remission (full Mayo score ≤2 with no subscore >1) at week 8 (induction primary end point; P = .265); among week-8 responders, 39.5% vs 29.0% receiving 40 mg ew vs 40 mg eow achieved clinical remission at week 52 (maintenance primary end point; P = .069). In the integrated (main + Japan) population, 41.1% vs 30.1% of week-8 responders receiving 40 mg ew vs 40 mg eow achieved clinical remission at week 52 (nominal P = .045). Safety profiles were comparable between dosing regimens. CONCLUSION: Although primary end points were not met, a >10% absolute difference in clinical remission was demonstrated with higher adalimumab maintenance dosing. Higher dosing regimens were generally well tolerated and consistent with the known safety profile of adalimumab in ulcerative colitis. CLINICALTRIALS: gov, Number: NCT002209456.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Panés, Julián;  Hospital Clinic de Barcelona, August Pi i Sunyer Biomedical Research Institute,
Colombel, Jean-Frederic;  Icahn School of Medicine at Mt Sinai, New York, New York.
D'Haens, Geert R;  Amsterdam Gastroenterology Endocrinology Metabolism and Gastroenterology and
Schreiber, Stefan;  Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel
Panaccione, Remo;  Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
Peyrin-Biroulet, Laurent;  Department of Gastroenterology, Centre Hospitalier Régional Universitaire de
Loftus, Edward V Jr;  Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
Danese, Silvio;  Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere
Tanida, Satoshi;  Department of Gastroenterology and Metabolism, Nagoya City University Graduate
Okuyama, Yusuke;  Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto,
Louis, Edouard  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive ; Department of Gastroenterology, University Hospital Centre Hospitalier
Armuzzi, Alessandro;  Inflammatory Bowel Diseases Unit, Fondazione Policlinico Universitario A. Gemelli
Ferrante, Marc;  Department of Gastroenterology and Hepatology, University Hospitals Leuven,
Vogelsang, Harald;  Medical University of Vienna, Vienna, Austria.
Hibi, Toshifumi;  Center for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato
Watanabe, Mamoru;  Advanced Research Institute and Department of Gastroenterology and Hepatology,
Lefebvre, Jessica;  AbbVie Inc, North Chicago, Illinois.
Finney-Hayward, Tricia;  AbbVie Ltd, Maidenhead, Berkshire, England, United Kingdom.
Sanchez Gonzalez, Yuri;  AbbVie Inc, North Chicago, Illinois.
Doan, Thao T;  AbbVie Inc, North Chicago, Illinois.
Mostafa, Nael M;  AbbVie Inc, North Chicago, Illinois.
Ikeda, Kimitoshi;  AbbVie GK, Minato-ku, Tokyo, Japan.
Xie, Wangang;  AbbVie Inc, North Chicago, Illinois.
Huang, Bidan;  AbbVie Inc, North Chicago, Illinois.
Petersson, Joel;  AbbVie Inc, North Chicago, Illinois.
Kalabic, Jasmina;  AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
Robinson, Anne M;  AbbVie Inc, North Chicago, Illinois.
Sandborn, William J;  Gastroenterology Department, University of California San Diego, La Jolla,
More authors (18 more) Less
Language :
English
Title :
Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results.
Publication date :
June 2022
Journal title :
Gastroenterology
ISSN :
0016-5085
eISSN :
1528-0012
Publisher :
Elsevier
Volume :
162
Issue :
7
Pages :
1891-1910
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
AbbVie [BE]
Commentary :
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved. © 2022 The Author(s). Published by Elsevier Inc. on behalf of the AGA Institute. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).0016-5085 https://doi.org/10.1053/j.gastro.2022.02.033
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