Dose-optimization strategies for biologic therapies in Crohn’s disease (CD) are not well established. SERENE CD 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 (CD Activity Index [CDAI] of 220-450, endoscopic evidence of mucosal inflammation, and previous failure of standard therapies) were randomized to higher induction regimen (HIR; adalimumab 160mg at weeks 0, 1, 2, and 3; N = 308) or standard induction regimen (SIR; adalimumab 160mg at week 0 and 80mg at week 2; N = 206) followed by 40mg every other week from week 4 onward. Coprimary endpoints included clinical remission at week 4 and endoscopic response at week 12. At week 12, patients were rerandomized to maintenance therapy optimized by CDAI and C-reactive protein (CA; N = 92) or serum adalimumab concentrations ± clinical criteria (TDM; N = 92); exploratory endpoints were evaluated at week 56.
Similar proportions of patients receiving HIR and SIR 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.
HIR was not superior to SIR, and CA and TDM maintenance strategies were similarly efficacious. Adalimumab therapy was well tolerated, and no new safety concerns were identified. (, Number: NCT02065570).

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