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High versus standard adalimumab in active UC

Presented By
Prof. J. Colombel, Icahn School of Medicine at Mount Sinai, USA
ECCO 2020
Phase 3, SERENE-UC
Higher maintenance doses of adalimumab resulted in more clinical responders after 1 year than standard doses. However, the difference did not reach statistical significance [1]. Prof. Jean-Frederic Colombel (Icahn School of Medicine at Mount Sinai, USA) explained that SERENE-UC was a phase 3, double-blind, randomised study evaluating higher versus standard adalimumab dosing regimens in 852 adult patients with moderate-to-severe ulcerative colitis (UC). After 8 weeks, responders (n=757) were re-randomised to either adalimumab 40 mg every week (40 EW); adalimumab 40 mg every other week (40 EOW); or exploratory adalimumab 40 mg with therapeutic drug monitoring (TDM) regimens. The primary efficacy endpoint was clinical remission, defined as a full Mayo score ≤2 with no subscore >1 at week 52. A total of 371 patients were included in the intention-to-treat (ITT)-group: 152, 145, and 74 in the respective treatment arms. Overall mean adalimumab exposure was 25...

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