Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results
Abstract
Background & aims: Dose-optimization strategies for biologic therapies in Crohn's disease (CD) are not well established. The SERENE CD (Study of a Novel Approach to Induction and Maintenance Dosing With Adalimumab in Patients With Moderate to Severe Crohn's Disease) trial evaluated higher vs standard adalimumab induction dosing and clinically adjusted (CA) vs therapeutic drug monitoring (TDM) maintenance strategies in patients with moderately to severely active CD. Methods: In this phase 3, randomized, double-blind, multicenter trial, eligible adults (Crohn's Disease Activity Index score of 220-450, endoscopic evidence of mucosal inflammation, and previous failure of standard therapies) were randomized to higher induction regimen (adalimumab 160 mg at weeks 0, 1, 2, and 3; n = 308) or standard induction regimen (adalimumab 160 mg at week 0 and 80 mg at week 2; n = 206) followed by 40 mg every other week from week 4 onward. Co-primary end points included clinical remission at week 4 and endoscopic response at week 12. At week 12, patients were re-randomized to maintenance therapy optimized by Crohn's Disease Activity Index and C-reactive protein (CA; n = 92) or serum adalimumab concentrations and/or clinical criteria (TDM; n = 92); exploratory end points were evaluated at week 56. Results: Similar proportions of patients receiving higher induction regimen and standard induction regimen achieved clinical remission at week 4 (44% in both; P = .939) and endoscopic response at week 12 (43% vs 39%, respectively, P = .462). Week 56 efficacy was similar between CA and TDM. Safety profiles were comparable between dosing regimens. Conclusions: Higher induction regimen was not superior to standard induction regimen, and CA and TDM maintenance strategies were similarly efficacious. Adalimumab therapy was well tolerated, and no new safety concerns were identified. (ClinicalTrials.gov, Number: NCT02065570).
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BibTeX
@article{dhaens2026higher,
title = {{Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results}},
author = {Geert d'Haens and William Sandborn and Edward Loftus and Stephen Hanauer and Stefan Schreiber and Laurent Peyrin‐biroulet and Remo Panaccione and Julián Panés and Filip Baert and Jean-Frederic Colombel and Marc Ferrante and Edouard Louis and Alessandro Armuzzi and Qian Zhou and Venkata Goteti and Nael Mostafa and Thao Doan and Joel Petersson and Tricia Finney-Hayward and Alexandra Song and Anne Robinson and Silvio Danese},
journal = {Gastroenterology},
year = {2026},
month = sep,
doi = {10.1053/j.gastro.2022.01.044},
url = {https://hal.science/hal-04167794v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results
AU - Geert d'Haens
AU - William Sandborn
AU - Edward Loftus
AU - Stephen Hanauer
AU - Stefan Schreiber
AU - Laurent Peyrin‐biroulet
AU - Remo Panaccione
AU - Julián Panés
AU - Filip Baert
AU - Jean-Frederic Colombel
AU - Marc Ferrante
AU - Edouard Louis
AU - Alessandro Armuzzi
AU - Qian Zhou
AU - Venkata Goteti
AU - Nael Mostafa
AU - Thao Doan
AU - Joel Petersson
AU - Tricia Finney-Hayward
AU - Alexandra Song
AU - Anne Robinson
AU - Silvio Danese
PY - 2026
DA - 2026/09/02
JO - Gastroenterology
DO - 10.1053/j.gastro.2022.01.044
UR - https://hal.science/hal-04167794v1
AB - Background & aims: Dose-optimization strategies for biologic therapies in Crohn's disease (CD) are not well established. The SERENE CD (Study of a Novel Approach to Induction and Maintenance Dosing With Adalimumab in Patients With Moderate to Severe Crohn's Disease) trial evaluated higher vs standard adalimumab induction dosing and clinically adjusted (CA) vs therapeutic drug monitoring (TDM) maintenance strategies in patients with moderately to severely active CD. Methods: In this phase 3, randomized, double-blind, multicenter trial, eligible adults (Crohn's Disease Activity Index score of 220-450, endoscopic evidence of mucosal inflammation, and previous failure of standard therapies) were randomized to higher induction regimen (adalimumab 160 mg at weeks 0, 1, 2, and 3; n = 308) or standard induction regimen (adalimumab 160 mg at week 0 and 80 mg at week 2; n = 206) followed by 40 mg every other week from week 4 onward. Co-primary end points included clinical remission at week 4 and endoscopic response at week 12. At week 12, patients were re-randomized to maintenance therapy optimized by Crohn's Disease Activity Index and C-reactive protein (CA; n = 92) or serum adalimumab concentrations and/or clinical criteria (TDM; n = 92); exploratory end points were evaluated at week 56. Results: Similar proportions of patients receiving higher induction regimen and standard induction regimen achieved clinical remission at week 4 (44% in both; P = .939) and endoscopic response at week 12 (43% vs 39%, respectively, P = .462). Week 56 efficacy was similar between CA and TDM. Safety profiles were comparable between dosing regimens. Conclusions: Higher induction regimen was not superior to standard induction regimen, and CA and TDM maintenance strategies were similarly efficacious. Adalimumab therapy was well tolerated, and no new safety concerns were identified. (ClinicalTrials.gov, Number: NCT02065570).
SN - 0016-5085
SN - 1528-0012
ER -