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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
被引:0
作者:
Panaccione, Remo
[1
]
Ma, Christopher
[1
,2
]
Jairath, Vipul
[2
,3
,4
]
Dignass, Axel
[5
]
Joshi, Namita
[6
]
Clark, Ryan
[6
]
Griffith, Jenny
[6
]
Kligys, Kristina
[6
]
Semwal, Monika
[6
]
Smith, Zachary
[7
]
Mitchell, Dominic
[7
]
Nunag, Dominic
[7
]
Ferrante, Marc
[8
]
机构:
[1] Univ Calgary, Div Gastroenterol & Hepatol, 2500 Univ Dr NW, Calgary, AB T2N 1N4, Canada
[2] Western Univ, Div Epidemiol & Biostat, London, ON, Canada
[3] Alimentiv Inc, London, ON, Canada
[4] Western Univ, Schulich Sch Med & Dent, Div Gastroenterol, London, ON, Canada
[5] Goethe Univ, Agaplesion Markus Hosp, Dept Med 1, Frankfurt, Germany
[6] AbbVie Inc, N Chicago, IL USA
[7] Medicus Econ LLC, Boston, MA USA
[8] Katholieke Univ Leuven, Univ Hosp Leuven, Dept Gastroenterol & Hepatol, Leuven, Belgium
关键词:
Endoscopy;
Crohn's disease;
hospitalization;
mucosal healing;
INFLAMMATORY-BOWEL-DISEASE;
SCIENTIFIC WORKSHOP;
OUTCOMES;
PREDICTORS;
GOALS;
SCORE;
D O I:
10.1093/ecco-jcc/jjae128
中图分类号:
R57 [消化系及腹部疾病];
学科分类号:
摘要:
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 data from 52-week Phase III maintenance trials of risankizumab and upadacitinib in patients with moderate-to-severe active CD.Methods Included patients received maintenance therapy after achieving a clinical response following a 12-week induction with risankizumab or upadacitinib. Endoscopic remission was defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) of no greater than 4, with at least a 2-point reduction vs 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 incidence rate ratios of 0.45 (95% confidence interval [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 a reduction in 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. Graphical Abstract
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页数:11