Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results
Abstract
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.
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BibTeX
@article{panes2026higher,
title = {{Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results}},
author = {Julián Panés and Jean-Frederic Colombel and Geert d'Haens and Stefan Schreiber and Remo Panaccione and Laurent Peyrin‐biroulet and Edward Loftus and Silvio Danese and Satoshi Tanida and Yusuke Okuyama and Edouard Louis and Alessandro Armuzzi and Marc Ferrante and Harald Vogelsang and Toshifumi Hibi and Mamoru Watanabe and Jessica Lefebvre and Tricia Finney-Hayward and Yuri Sanchez Gonzalez and Thao Doan and Nael Mostafa and Kimitoshi Ikeda and Wangang Xie and Bidan Huang and Joel Petersson and Jasmina Kalabic and Anne Robinson and William Sandborn},
journal = {Gastroenterology},
year = {2026},
month = sep,
doi = {10.1053/j.gastro.2022.02.033},
url = {https://hal.univ-lorraine.fr/hal-04165947v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results
AU - Julián Panés
AU - Jean-Frederic Colombel
AU - Geert d'Haens
AU - Stefan Schreiber
AU - Remo Panaccione
AU - Laurent Peyrin‐biroulet
AU - Edward Loftus
AU - Silvio Danese
AU - Satoshi Tanida
AU - Yusuke Okuyama
AU - Edouard Louis
AU - Alessandro Armuzzi
AU - Marc Ferrante
AU - Harald Vogelsang
AU - Toshifumi Hibi
AU - Mamoru Watanabe
AU - Jessica Lefebvre
AU - Tricia Finney-Hayward
AU - Yuri Sanchez Gonzalez
AU - Thao Doan
AU - Nael Mostafa
AU - Kimitoshi Ikeda
AU - Wangang Xie
AU - Bidan Huang
AU - Joel Petersson
AU - Jasmina Kalabic
AU - Anne Robinson
AU - William Sandborn
PY - 2026
DA - 2026/09/02
JO - Gastroenterology
DO - 10.1053/j.gastro.2022.02.033
UR - https://hal.univ-lorraine.fr/hal-04165947v1
AB - 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.
SN - 0016-5085
SN - 1528-0012
ER -