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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 252.2 days.

Clinical remission at week 52 was reached by 39.5%, 29.0%, and 36.5% of patients in the respective treatment arms; see Table for all efficacy outcomes. Prof. Colombel concluded: “In patients receiving adalimumab 40 EW, clinical remission was 10.5% higher among week 8 responders compared with 40 EOW maintenance regimens, but this difference was not statistically significant. However, the integrated data of the main study and a small study performed in Japan (n=89) demonstrated significantly greater clinical remission rates at week 52 with 40 EW versus 40 EOW, with a difference of 11.1% (P=0.045). The safety of 40 EW and 40 EOW was similar; there were no new safety signals.”

Table. Efficacy endpoints among week 8 responders of SERENE-UC at week 52 [1]

*of week 8 responders taking steroids at baseline; EW, every week; EOW, every other week; TDM, therapeutic drug monitoring; IBDQ, Inflammatory Bowel Disease Questionnaire.

  1. Colombel JF, et al. ECCO-IBD 2020, OP01.



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