Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease.
Julian Panés, Edouard Louis, Peter Bossuyt, Namita Joshi, Wan-Ju Lee, Ana P Lacerda, Kristina Kligys, Si Xuan, Nidhi Shukla, Edward V Loftus
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引用次数: 0
Abstract
Background: We evaluated the association of achieving endoscopic outcomes at week 12 of induction with improvements in clinical outcomes and quality of life (QoL) at week 52 of maintenance in patients with moderately to severely active Crohn's disease (CD) treated with upadacitinib (UPA).
Methods: This post hoc analysis evaluated data from 2 phase 3 induction trials (NCT03345836 and NCT03345849) and 1 maintenance (NCT03345823) trial. Clinical responders to 12-week induction therapy with UPA who also received 52-week maintenance treatment with UPA were included. Endoscopic response, remission, healing, and ulcer-free endoscopy were assessed at week 12. Meaningful improvements in clinical and QoL outcomes were evaluated at week 52.
Results: A significantly greater proportion of patients who achieved an endoscopic response at the end of induction, compared with patients who did not, attained Crohn's Disease Activity Index (CDAI) remission (52.0% vs 34.6%; P ≤ .01), corticosteroid-free CDAI remission (50.0% vs 30.9%), Inflammatory Bowel Disease Questionnaire remission (52.6% vs 30.3%), and meaningful improvements in Functional Assessment of Chronic Illness Therapy-Fatigue response (46.7% vs 25.9%), overall work impairment (47.1% vs 26.5%), and daily activity impairment (53.3% vs 34.1%) (all P < .05) at week 52. Similar findings were observed for patients who achieved endoscopic remission, endoscopic healing, and ulcer-free endoscopy at the end of induction vs those who did not.
Conclusions: Early improvement in endoscopic outcomes after UPA induction treatment was associated with long-term meaningful improvements in clinical outcomes and QoL in patients with CD.
背景：我们评估了接受乌达替尼（UPA）治疗的中重度活动性克罗恩病（CD）患者在诱导治疗第12周时达到内镜检查结果与维持治疗第52周时临床结果和生活质量（QoL）改善的相关性：这项事后分析评估了2项3期诱导试验（NCT03345836和NCT03345849）和1项维持治疗试验（NCT03345823）的数据。研究对象包括接受 UPA 12 周诱导治疗并同时接受 UPA 52 周维持治疗的临床应答者。在第 12 周时对内镜反应、缓解、愈合和无溃疡内镜进行评估。第52周时评估临床和生活质量结果的显著改善：9%）、炎症性肠病问卷调查缓解率（52.6% vs 30.3%），以及慢性疾病治疗功能评估-疲劳反应（46.7% vs 25.9%）、总体工作损伤（47.1% vs 26.5%）和日常活动损伤（53.3% vs 34.1%）均有明显改善（均为P 结论：内镜治疗的早期疗效明显改善：UPA诱导治疗后内镜结果的早期改善与CD患者临床结果和QoL的长期有意义的改善相关：临床注册号：U-EXCEED诱导试验（NCT03345836）、U-EXCEL诱导试验（NCT03345849）和U-ENDURE维持试验（NCT03345823）。
期刊介绍：
Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.
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