Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program.

IF 3.4 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES Patient-Patient Centered Outcomes Research Pub Date : 2023-03-01 DOI:10.1007/s40271-022-00603-w

David P Hudesman, Joana Torres, Leonardo Salese, John C Woolcott, Rajiv Mundayat, Chinyu Su, Mahmoud H Mosli, Jessica R Allegretti

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Abstract

Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The tofacitinib OCTAVE clinical program included phase III induction (OCTAVE Induction 1 and 2) and maintenance (OCTAVE Sustain) studies, and an open-label, long-term extension study (OCTAVE Open).

Objective: This post hoc analysis assessed selected long-term, disease-specific patient-reported outcome (PRO) and health-related quality-of-life (HRQoL) measurements in patients with UC receiving tofacitinib in the OCTAVE clinical program.

Methods: Analyses included patients from OCTAVE Open assigned to tofacitinib 5 mg twice daily (subpopulation in remission at Week 52 of OCTAVE Sustain). OCTAVE Open data from the final analyses are shown to Month 48. Endpoints included rectal bleeding subscore (RBS) = 0, stool frequency subscore (SFS) ≤ 1, and HRQoL measure, Inflammatory Bowel Disease Questionnaire (IBDQ) remission (IBDQ total score ≥ 170); with non-responder imputation for missing data at all visits, and last observation carried forward for visits after a patient advanced to the next study (NRI-LOCF). Observed cases were also assessed.

Results: At Month 48, of 175 patients, 95 (54.3%) and 96 (54.9%) achieved/maintained RBS = 0 and SFS ≤ 1, respectively (NRI-LOCF). Additionally, 93 (53.1%) patients achieved/maintained IBDQ remission at Month 48 (NRI-LOCF).

Conclusions: Among patients who entered OCTAVE Open in remission, most maintained normalization of rectal bleeding and improvement in stool frequency for ≤ 4 years of follow-up in OCTAVE Open. IBDQ remission was also generally maintained in OCTAVE Open. These data show robust maintenance of key UC PROs and durability of response with tofacitinib 5 mg twice daily.

Trial registration: http://www.

Clinicaltrials: gov (NCT01465763 [21/10/2011]; NCT01458951 [21/10/2011]; NCT01458574 [21/10/2011]; NCT01470612 [21/10/2011]).

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在溃疡性结肠炎OCTAVE临床项目中，托法替尼对患者报告的直肠出血、大便频率和健康相关生活质量的长期改善

背景:托法替尼是一种用于治疗溃疡性结肠炎(UC)的口服小分子Janus激酶抑制剂。tofacitinib OCTAVE临床项目包括III期诱导(OCTAVE induction 1和2)和维持(OCTAVE Sustain)研究，以及一项开放标签的长期扩展研究(OCTAVE Open)。目的:本事后分析评估了在OCTAVE临床项目中接受托法替尼治疗的UC患者选择的长期、疾病特异性患者报告结果(PRO)和健康相关生活质量(HRQoL)测量。方法:分析包括来自OCTAVE Open的患者，分配给tofacitinib 5mg，每天两次(在OCTAVE Sustain的第52周缓解的亚群)。OCTAVE Open的最终分析数据显示至第48个月。终点包括直肠出血亚评分(RBS) = 0，大便频率亚评分(SFS)≤1,HRQoL测量，炎症性肠病问卷(IBDQ)缓解(IBDQ总分≥170);对所有就诊数据的缺失进行无应答归因，并在患者进展到下一个研究(NRI-LOCF)后将最后一次观察延续到就诊。还对观察到的病例进行了评估。结果:在第48个月，175例患者中，分别有95例(54.3%)和96例(54.9%)达到/维持RBS = 0和SFS≤1 (NRI-LOCF)。此外，93例(53.1%)患者在第48个月(NRI-LOCF)达到/维持IBDQ缓解。结论:在进入OCTAVE Open治疗缓解期的患者中，大多数患者在OCTAVE Open治疗中保持直肠出血正常化和大便频率改善≤4年。在OCTAVE Open中，IBDQ也普遍保持缓解。这些数据显示，托法替尼5mg每日2次对关键UC pro的维持和反应的持久性。试验注册:http://www.Clinicaltrials: gov (NCT01465763 [21/10/2011];NCT01458951 [21/10/2011];NCT01458574 [21/10/2011];NCT01470612[21/10/2011])。

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来源期刊

Patient-Patient Centered Outcomes Research HEALTH CARE SCIENCES & SERVICES-

CiteScore

6.60

自引率

8.30%

发文量

审稿时长

>12 weeks

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