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Achievement of Endoscopic Remission After Induction Reduces Hospitalization Burden in Crohn's Disease: Findings From a Pooled Post Hoc Analysis of Risankizumab and Upadacitinib Phase III Trials.
Panaccione, Remo; Ma, Christopher; Jairath, Vipul; Dignass, Axel; Joshi, Namita; Clark, Ryan; Griffith, Jenny; Kligys, Kristina; Semwal, Monika; Smith, Zachary; Mitchell, Dominic; Nunag, Dominic; Ferrante, Marc.
Afiliación
  • Panaccione R; University of Calgary, Calgary, AB, Canada.
  • Ma C; University of Calgary, Calgary, AB, Canada.
  • Jairath V; Western University, Alimentiv Inc, London, ON, Canada.
  • Dignass A; Western University, Alimentiv Inc, London, ON, Canada.
  • Joshi N; Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt Am Main, Germany.
  • Clark R; AbbVie Inc., North Chicago, IL, USA.
  • Griffith J; AbbVie Inc., North Chicago, IL, USA.
  • Kligys K; AbbVie Inc., North Chicago, IL, USA.
  • Semwal M; AbbVie Inc., North Chicago, IL, USA.
  • Smith Z; AbbVie Inc., North Chicago, IL, USA.
  • Mitchell D; Medicus Economics LLC, Boston, MA, USA.
  • Nunag D; Medicus Economics LLC, Boston, MA, USA.
  • Ferrante M; Medicus Economics LLC, Boston, MA, USA.
J Crohns Colitis ; 2024 Aug 30.
Article en En | MEDLINE | ID: mdl-39212931
ABSTRACT

BACKGROUND:

Endoscopic remission has emerged as an important treatment target in Crohn's disease (CD) and has been associated with improvement in long-term outcomes. We examined the relationship between achievement of endoscopic remission and hospitalizations using pooled 52-week Phase III risankizumab and upadacitinib maintenance trials for patients with moderate-to-severely active CD.

METHODS:

Included patients received maintenance therapy after achieving a clinical response following a 12-week induction with risankizumab or upadacitinib. Endoscopic remission defined as a Simple Endoscopic Score for CD no greater than 4 with at least a 2-point reduction versus induction baseline and no subscore greater than 1. All subsequent hospitalization events were recorded until completion of the maintenance trial or discontinuation. Exposure-adjusted negative binomial regression models were estimated to assess the relationship between post-induction endoscopic remission and long-term hospitalization, controlling for demographics, clinical variables, and treatment arm.

RESULTS:

Post-induction hospitalization rates were lower in patients who achieved endoscopic remission at the end of the induction period. In multivariable models, post-induction endoscopic remission was independently associated with an IRR of 0.45 (95% CI [0.22-0.95], p=0.036) and 0.71 (95% CI [0.44-1.14], p=0.156) for long-term disease-related and all-cause hospitalizations, respectively.

CONCLUSIONS:

Week 12 endoscopic remission is independently associated with reducing 52-week disease-related hospitalizations. However, achieving this stringent endpoint within 12 weeks of therapy may be challenging. Endoscopic response may be a more realistic early endoscopic target in the post-induction timeframe. Additional research is needed to evaluate early achievement of alternative endoscopic endpoints in CD.
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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: Canadá Pais de publicación: Reino Unido

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: Canadá Pais de publicación: Reino Unido