Dept of Gastroenterology, Royal London Hospital, Barts Health NHS Trust, London, UK.
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
J Gastroenterol. 2023 Oct;58(10):990-1002. doi: 10.1007/s00535-023-02013-7. Epub 2023 Jul 25.
We evaluated the clinical relevance of achieving histologic endoscopic mucosal improvement (HEMI) and the more stringent target of histologic endoscopic mucosal remission (HEMR) in the phase 3 maintenance trial of upadacitinib for moderately to severely active ulcerative colitis.
Clinical and patient-reported outcomes were assessed in patients with clinical response after 8- or 16-week upadacitinib induction who received 52-week upadacitinib maintenance treatment. Cross-sectional and predictive analyses evaluated the relationship between HEMR or HEMI at Week 8/16 and Week 52, respectively, and outcomes at Week 52. Adjusted odds ratios (aOR) were derived from logistic regressions for patients achieving HEMR or HEMI without HEMR versus those not achieving HEMI.
Cross-sectional analyses showed that patients with HEMR had greater odds of achieving all clinical and patient-reported outcomes at Week 52 than those not achieving HEMI. In predictive analyses, patients with HEMR at Week 8/16 had significantly greater odds of achieving clinical remission (aOR = 3.6, p = 0.001) and endoscopic remission (aOR = 3.9, p < 0.001) at Week 52 than patients not achieving HEMI and HEMR. For patients achieving HEMI without HEMR, these odds were lower: clinical remission (aOR = 3.2, p < 0.001) and endoscopic remission (aOR = 2.4, p = 0.010). The odds of achieving clinically meaningful improvements in most patient-reported outcomes were directionally similar between HEMI and HEMR, but not statistically different to patients not achieving HEMI. No hospitalizations or surgeries were observed in patients with HEMR at Week 52.
Achievement of HEMR or HEMI is clinically relevant with HEMR being associated with greater likelihood of improvement in long-term clinical and patient-reported outcomes. https://www.
gov NCT02819635.
我们评估了在 UPADACITINIB 治疗中度至重度活动溃疡性结肠炎的 3 期维持试验中，实现组织学内镜黏膜改善（HEMI）和更严格的组织学内镜黏膜缓解（HEMR）目标的临床相关性。
在接受 UPADACITINIB 维持治疗 52 周后，对 8 或 16 周 UPADACITINIB 诱导后获得临床缓解的患者进行临床和患者报告结局评估。横断面和预测性分析分别评估了第 8/16 周时的 HEMR 或 HEMI 与第 52 周时的关系，以及第 52 周时的结局。来自逻辑回归的调整优势比（aOR）用于评估在没有 HEMI 的情况下达到 HEMR 或 HEMI 的患者与未达到 HEMI 的患者相比。
横断面分析显示，在第 52 周时，达到 HEMR 的患者比未达到 HEMI 的患者更有可能达到所有临床和患者报告结局。在预测性分析中，在第 8/16 周达到 HEMR 的患者在第 52 周时达到临床缓解（aOR=3.6，p=0.001）和内镜缓解（aOR=3.9，p<0.001）的可能性显著高于未达到 HEMI 和 HEMR 的患者。对于达到 HEMI 但未达到 HEMR 的患者，这些可能性较低：临床缓解（aOR=3.2，p<0.001）和内镜缓解（aOR=2.4，p=0.010）。在 HEMI 和 HEMR 之间，大多数患者报告结局的临床意义改善的可能性方向相似，但与未达到 HEMI 的患者没有统计学差异。在第 52 周时，达到 HEMR 的患者没有发生住院或手术。
达到 HEMR 或 HEMI 与临床相关，HEMR 与改善长期临床和患者报告结局的可能性更大相关。临床试验：gov NCT02819635。
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