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
引用
收藏
页数:11
相关论文
共 11 条
  • [11] Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies
    D'Haens, Geert
    Baert, Filip
    Danese, Silvio
    Kobayashi, Taku
    Loftus, Edward V.
    Sandborn, William J.
    Dornic, Quentin
    Lindner, Dirk
    Kisfalvi, Krisztina
    Marins, Ed G.
    Vermeire, Severine
    EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY, 2024, 36 (04) : 404 - 415