Panés Julian, Louis Edouard, Bossuyt Peter, Joshi Namita, Lee Wan-Ju, Lacerda Ana P, Kligys Kristina, Xuan Si, Shukla Nidhi, Loftus Edward V
Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Department of Clinical Sciences, University Hospital CHU of Liège, Liège, Belgium.
Inflamm Bowel Dis. 2025 Feb 6;31(2):394-403. doi: 10.1093/ibd/izae200.
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).
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.
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.
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.
U-EXCEED induction trial (NCT03345836), U-EXCEL induction trial (NCT03345849), and U-ENDURE maintenance trial (NCT03345823).
我们评估了接受乌帕替尼（UPA）治疗的中度至重度活动性克罗恩病（CD）患者在诱导治疗第12周达到内镜治疗效果与维持治疗第52周临床疗效和生活质量（QoL）改善之间的关联。
这项事后分析评估了来自2项3期诱导试验（NCT03345836和NCT03345849）和1项维持试验（NCT03345823）的数据。纳入了对UPA进行12周诱导治疗有临床反应且也接受了UPA 52周维持治疗的患者。在第12周评估内镜反应、缓解、愈合和无溃疡内镜检查情况。在第52周评估临床和QoL结局的有意义改善情况。
与未达到内镜反应的患者相比，诱导治疗结束时达到内镜反应的患者在第52周实现克罗恩病活动指数（CDAI）缓解（52.0%对34.6%；P≤0.01）、无皮质类固醇CDAI缓解（50.0%对30.9%）、炎症性肠病问卷缓解（52.6%对30.3%）以及慢性疾病治疗功能评估-疲劳反应（46.7%对25.9%）、总体工作障碍（47.1%对26.5%）和日常活动障碍（53.3%对34.1%）有意义改善的比例显著更高（所有P<0.05）。对于诱导治疗结束时达到内镜缓解、内镜愈合和无溃疡内镜检查的患者与未达到的患者，观察到类似结果。
UPA诱导治疗后内镜结局的早期改善与CD患者的临床结局和QoL的长期有意义改善相关。
U-EXCEED诱导试验（NCT03345836）、U-EXCEL诱导试验（NCT03345849）和U-ENDURE维持试验（NCT03345823）。
