DOP42 Efficacy of etrasimod on symptomatic relief in patients with ulcerative colitis: an analysis of the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials

Autor: M Chaparro, A Armuzzi, P M Irving, M Allez, M C Dubinsky, B E Sands, M Goetsch, W Wang, K Shan, J Woolcott, L Bartolome, K Wosik, R Panaccione
Rok vydání: 2023
Předmět:
Zdroj: Journal of Crohn's and Colitis. 17:i107-i110
ISSN: 1876-4479
1873-9946
DOI: 10.1093/ecco-jcc/jjac190.0082
Popis: Background Patient-reported outcomes such as stool frequency (SF) and rectal bleeding (RB) are important measures of ulcerative colitis (UC) activity and treatment effect. Etrasimod is an investigational, once-daily, oral, selective sphingosine 1-phosphate receptor 1,4,5 (S1P1,4,5) modulator in development for the treatment of moderately to severely active UC. We evaluated RB and SF subscores to assess symptomatic relief in the ELEVATE UC phase 3 programme. Methods In ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369), patients (16-80 years) with moderately to severely active UC were randomised 2:1 to once-daily etrasimod 2 mg or placebo (PBO). ELEVATE UC 52 utilized a treat-through design comprising a 12-week induction period followed by a 40-week maintenance period. ELEVATE UC 12 comprised a 12-week induction period. A key secondary endpoint was the proportion of patients with symptomatic remission (SF =0 [or =1 with a ≥1-point decrease from baseline] and RB =0) at week 12 and at week 52. RB and SF subscores, achievement of symptomatic remission, complete symptomatic remission (SF =0 and RB =0), and symptomatic response (≥30% decrease from baseline in composite RB/SF subscores) were assessed at each visit. Achievement of symptomatic remission was also summarized by subgroups in patients with prior biologic/Janus kinase inhibitor (bio/JAKi) use (yes [1, >1], no) and baseline corticosteroid use (yes, no). Results More etrasimod- vs PBO-treated patients achieved symptomatic remission by week 2 in ELEVATE UC 52 (15.3% vs 8.9%; P=0.049) and week 4 in ELEVATE UC 12 (27.5% vs 16.1%; P=0.007). Symptomatic remission increased in etrasimod- vs PBO-treated patients at each time point through week 12 in both ELEVATE UC 52 (46.0% vs 21.5%; P1) (Figures 2A-C). Conclusion In this analysis, symptomatic relief was achieved by a greater proportion of patients treated with etrasimod vs PBO as early as week 2 and was sustained through week 52. At week 2, symptomatic response and improvements in RB and SF subscores were observed. The greatest benefits were seen in patients who had no prior exposure to bio/JAKi or 1 prior bio/JAKi therapy.
Databáze: OpenAIRE
Externí odkaz: