医学
阿达木单抗
加药
内科学
随机对照试验
肿瘤坏死因子α
作者
Geert R. D’Haens,William J. Sandborn,Edward V. Loftus,Stephen B. Hanauer,Stefan Schreiber,Laurent Peyrin‐Biroulet,Remo Panaccione,Julián Panés,Filip Baert,Jean‐Frédéric Colombel,Marc Ferrante,Édouard Louis,Alessandro Armuzzi,Qian Zhou,Venkata Sasikiran Goteti,Nael M. Mostafa,Thao Doan,Joel Petersson,Tricia Finney‐Hayward,Alexandra Song
出处
期刊:Gastroenterology
[Elsevier BV]
日期:2022-02-03
卷期号:162 (7): 1876-1890
被引量:65
标识
DOI:10.1053/j.gastro.2022.01.044
摘要
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.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.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.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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