Subrata Ghosh, Brian G Feagan, Rogério Serafim Parra, Susana Lopes, Adam Steinlauf, Yoichi Kakuta, Namita Joshi, Wan-Ju Lee, Ana P Lacerda, Qian Zhou, Si Xuan, Kristina Kligys, Nidhi Shukla, Edouard Louis
{"title":"奥达帕替尼诱导和维持治疗对中度至重度活动性克罗恩病患者健康相关生活质量、疲劳和工作效率的影响。","authors":"Subrata Ghosh, Brian G Feagan, Rogério Serafim Parra, Susana Lopes, Adam Steinlauf, Yoichi Kakuta, Namita Joshi, Wan-Ju Lee, Ana P Lacerda, Qian Zhou, Si Xuan, Kristina Kligys, Nidhi Shukla, Edouard Louis","doi":"10.1093/ecco-jcc/jjae083","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aims: </strong>Quality of life in patients with active Crohn's disease may be significantly reduced. We evaluated the effects of upadacitinib induction and maintenance therapy on fatigue, quality of life, and work productivity in the phase 3 trials U-EXCEL, U-EXCEED, and U-ENDURE.</p><p><strong>Methods: </strong>Clinical responders to upadacitinib 45 mg in U-EXCEL and U-EXCEED induction trials were re-randomised 1:1:1 to upadacitinib 30 mg, 15 mg, or placebo for 52 weeks of maintenance in U-ENDURE. Clinically meaningful improvements in Inflammatory Bowel Disease Questionnaire [IBDQ] response, IBDQ remission, Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], and Work Productivity and Activity Impairment were evaluated. Percentages of patients achieving clinically meaningful improvements were assessed at induction Weeks 4 and 12 and maintenance Week 52.</p><p><strong>Clinical registration number: </strong>U-EXCEED induction trial [NCT03345836], U-EXCEL induction trial [NCT03345849], U-ENDURE maintenance trial [NCT03345823].</p><p><strong>Results: </strong>Analysis included 1021 and 502 patients assessed at induction and maintenance, respectively. In U-EXCEL, greater improvements [all p ≤ 0.001] in IBDQ response [71.0% vs 50.2%], IBDQ remission [44.2% vs 23.7%], and FACIT-Fatigue [42.0% vs 27.0%] were observed in upadacitinib-treated patients versus placebo at Week 4. Improvements in IBDQ response, IBDQ remission, and FACIT-Fatigue were similar or greater at Week 12. Clinically meaningful improvement in overall work impairment [52.1% vs 38.1%, p ≤ 0.05] was demonstrated at Week 12. Similar results were observed in U-EXCEED. Improvements were sustained through 52 weeks of upadacitinib maintenance treatment.</p><p><strong>Conclusions: </strong>In patients with active Crohn's disease, upadacitinib treatment relative to placebo significantly improved fatigue, quality of life, and work productivity as early as Week 4. These effects were sustained through 52 weeks of maintenance.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":"1804-1818"},"PeriodicalIF":0.0000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532615/pdf/","citationCount":"0","resultStr":"{\"title\":\"Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease.\",\"authors\":\"Subrata Ghosh, Brian G Feagan, Rogério Serafim Parra, Susana Lopes, Adam Steinlauf, Yoichi Kakuta, Namita Joshi, Wan-Ju Lee, Ana P Lacerda, Qian Zhou, Si Xuan, Kristina Kligys, Nidhi Shukla, Edouard Louis\",\"doi\":\"10.1093/ecco-jcc/jjae083\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and aims: </strong>Quality of life in patients with active Crohn's disease may be significantly reduced. We evaluated the effects of upadacitinib induction and maintenance therapy on fatigue, quality of life, and work productivity in the phase 3 trials U-EXCEL, U-EXCEED, and U-ENDURE.</p><p><strong>Methods: </strong>Clinical responders to upadacitinib 45 mg in U-EXCEL and U-EXCEED induction trials were re-randomised 1:1:1 to upadacitinib 30 mg, 15 mg, or placebo for 52 weeks of maintenance in U-ENDURE. Clinically meaningful improvements in Inflammatory Bowel Disease Questionnaire [IBDQ] response, IBDQ remission, Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], and Work Productivity and Activity Impairment were evaluated. Percentages of patients achieving clinically meaningful improvements were assessed at induction Weeks 4 and 12 and maintenance Week 52.</p><p><strong>Clinical registration number: </strong>U-EXCEED induction trial [NCT03345836], U-EXCEL induction trial [NCT03345849], U-ENDURE maintenance trial [NCT03345823].</p><p><strong>Results: </strong>Analysis included 1021 and 502 patients assessed at induction and maintenance, respectively. In U-EXCEL, greater improvements [all p ≤ 0.001] in IBDQ response [71.0% vs 50.2%], IBDQ remission [44.2% vs 23.7%], and FACIT-Fatigue [42.0% vs 27.0%] were observed in upadacitinib-treated patients versus placebo at Week 4. Improvements in IBDQ response, IBDQ remission, and FACIT-Fatigue were similar or greater at Week 12. Clinically meaningful improvement in overall work impairment [52.1% vs 38.1%, p ≤ 0.05] was demonstrated at Week 12. Similar results were observed in U-EXCEED. 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引用次数: 0
摘要
背景和目的：活动性克罗恩病患者的生活质量可能会明显下降。我们评估了U-EXCEL、U-EXCEED和U-ENDURE三期试验中奥达帕替尼诱导和维持治疗对疲劳、生活质量和工作效率的影响：在U-EXCEL和U-EXCEED诱导试验中对高达替尼45毫克临床应答者在U-ENDURE中被1:1:1重新随机分配到高达替尼30毫克、15毫克或安慰剂中进行为期52周的维持治疗。对患者在炎症性肠病问卷（IBDQ）反应、IBDQ缓解、慢性疾病治疗功能评估-疲劳（FACIT-疲劳）以及工作效率和活动障碍方面有临床意义的改善进行了评估。在诱导治疗第 4 周和第 12 周以及维持治疗第 52 周时，对获得有临床意义改善的患者比例进行评估：分析结果显示，分别有 1021 名和 502 名患者在诱导期和维持期接受了评估。在 U-EXCEL 中，与安慰剂相比，达帕替尼治疗的患者在第 4 周时的 IBDQ 反应（71.0% vs 50.2%）、IBDQ 缓解（44.2% vs 23.7%）和 FACIT-Fatigue （42.0% vs 27.0%）改善幅度更大（均 p≤0.001）。第12周时，IBDQ反应、IBDQ缓解和FACIT-疲劳的改善程度相似或更大。第12周时，总体工作损伤得到了有临床意义的改善（52.1% vs 38.1%，p≤0.05）。在 U-EXCEED 中也观察到了类似的结果。在达达替尼维持治疗52周后，改善效果得以持续：结论：在活动性克罗恩病患者中，与安慰剂相比，奥达替尼治疗早在第4周就能显著改善疲劳、生活质量和工作效率。这些效果在52周的维持治疗中得以持续。
Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease.
Background and aims: Quality of life in patients with active Crohn's disease may be significantly reduced. We evaluated the effects of upadacitinib induction and maintenance therapy on fatigue, quality of life, and work productivity in the phase 3 trials U-EXCEL, U-EXCEED, and U-ENDURE.
Methods: Clinical responders to upadacitinib 45 mg in U-EXCEL and U-EXCEED induction trials were re-randomised 1:1:1 to upadacitinib 30 mg, 15 mg, or placebo for 52 weeks of maintenance in U-ENDURE. Clinically meaningful improvements in Inflammatory Bowel Disease Questionnaire [IBDQ] response, IBDQ remission, Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], and Work Productivity and Activity Impairment were evaluated. Percentages of patients achieving clinically meaningful improvements were assessed at induction Weeks 4 and 12 and maintenance Week 52.
Results: Analysis included 1021 and 502 patients assessed at induction and maintenance, respectively. In U-EXCEL, greater improvements [all p ≤ 0.001] in IBDQ response [71.0% vs 50.2%], IBDQ remission [44.2% vs 23.7%], and FACIT-Fatigue [42.0% vs 27.0%] were observed in upadacitinib-treated patients versus placebo at Week 4. Improvements in IBDQ response, IBDQ remission, and FACIT-Fatigue were similar or greater at Week 12. Clinically meaningful improvement in overall work impairment [52.1% vs 38.1%, p ≤ 0.05] was demonstrated at Week 12. Similar results were observed in U-EXCEED. Improvements were sustained through 52 weeks of upadacitinib maintenance treatment.
Conclusions: In patients with active Crohn's disease, upadacitinib treatment relative to placebo significantly improved fatigue, quality of life, and work productivity as early as Week 4. These effects were sustained through 52 weeks of maintenance.
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