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Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in UC: Analyses of the ELEVATE UC Clinical Programme.
Sands, Bruce E; Leung, Yvette; Rubin, David T; Gecse, Krisztina B; Panés, Julian; Goetsch, Martina; Wang, Wenjin; Woolcott, John C; Smith, Christina C; Wosik, Karolina; Schreiber, Stefan.
Afiliación
  • Sands BE; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Leung Y; Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Rubin DT; University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.
  • Gecse KB; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
  • Panés J; Formerly Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
  • Goetsch M; Pfizer AG, Zürich, Switzerland.
  • Wang W; Pfizer Inc, Collegeville, PA, USA.
  • Woolcott JC; Pfizer Inc, Collegeville, PA, USA.
  • Smith CC; Pfizer Inc, Collegeville, PA, USA.
  • Wosik K; Pfizer Inc, Kirkland, QC, Canada.
  • Schreiber S; Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
J Crohns Colitis ; 2024 Sep 22.
Article en En | MEDLINE | ID: mdl-39306680
ABSTRACT

BACKGROUND:

Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). This post hoc analysis reports efficacy and safety by baseline corticosteroid use in the ELEVATE UC clinical programme.

METHODS:

Patients with UC received etrasimod 2 mg or placebo for up to 52 weeks. Corticosteroid use was permitted; tapering was recommended from Week 12. Efficacy was assessed at Weeks 12 and 52 in ELEVATE UC 52, and Week 12 in ELEVATE UC 12, in patients in the corticosteroid (CS) and no-CS subgroups. CS-free efficacy at Week 52 was assessed in patients with baseline CS use.

RESULTS:

In ELEVATE UC 52 and ELEVATE UC 12, 93/289 (32.2%) and 65/238 (27.3%) patients receiving etrasimod and 42/144 (29.2%) and 34/116 (29.3%) patients receiving placebo, respectively, had concomitant CS use at baseline. In the CS and no-CS subgroups, higher proportions of patients who received etrasimod vs placebo achieved clinical remission (p < 0.05) in ELEVATE UC 52 at Weeks 12 (CS 32.3% vs 16.7%; no-CS 26.0% vs 4.9%) and 52 (CS 31.2% vs 9.5%; no-CS 33.2% vs 6.9%). In the CS subgroup, significantly more patients receiving etrasimod than placebo achieved CS-free clinical remission at Week 52 (31.2% vs 7.1%). No increases in infection rates were observed with baseline CS use. Safety was comparable between subgroups.

CONCLUSIONS:

Etrasimod demonstrated efficacy in inducing and maintaining remission in both subgroups. CSfree remission was achieved in the CS subgroup. Safety was consistent, with no increase in infections.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido