Home > Gastroenterology > ECCO 2020 > Specific Therapeutic Strategies > High versus standard adalimumab in active UC

High versus standard adalimumab in active UC

Presented By
Prof. J. Colombel, Icahn School of Medicine at Mount Sinai, USA
Conference
ECCO 2020
Trial
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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