University Hospital Schleswig-Holstein, Kiel, Germany.
Alimentiv Inc., London, Ontario, Canada.
J Crohns Colitis. 2023 Jun 16;17(6):863-875. doi: 10.1093/ecco-jcc/jjad018.
Ulcerative colitis [UC] impacts patients' health-related quality of life [HRQoL]. We assessed HRQoL and an exploratory patient-level composite endpoint ('Comprehensive Disease Control' [CDC]) in individuals receiving filgotinib [an oral JAK1 preferential inhibitor] in the SELECTION trial.
In SELECTION [NCT02914522], a double-blind, randomized, placebo-controlled, phase 2b/3 trial, adults with moderately to severely active UC received once-daily filgotinib 200 mg, filgotinib 100 mg or placebo for 11 weeks in Induction Study A [biologic-naïve] or B [biologic-experienced]. Filgotinib responders [week 10 clinical remission/response] were re-randomized to their filgotinib regimen or placebo for the 48-week Maintenance Study. We assessed week 10 and week 58 SF-36, EQ-5D, WPAI and IBDQ scores. Achievement of CDC (patient-level partial Mayo Clinic Score [pMCS] remission [pMCS ≤2, no individual rectal bleeding, stool frequency or physician's global assessment subscore >1], endoscopic improvement [endoscopic subscore ≤1], faecal calprotectin <150 µg/g and IBDQ score ≥170) and its association with HRQoL and histological outcomes were also explored.
Analyses included 382 biologic-naïve and 404 biologic-experienced patients. Filgotinib 200 mg induced and maintained improvements vs placebo in SF-36, EQ-5D, WPAI and IBDQ scores, and restored HRQoL by week 10. Proportionally more filgotinib 200 mg- than placebo-treated patients achieved CDC at weeks 10 and 58 [p < 0.01]. CDC was associated with clinically important improvements in HRQoL and histological remission over both periods.
Filgotinib 200 mg results in short- and long-term improvements in HRQoL. High-level improvement of HRQoL relates to a stringent composite endpoint suggesting meaningful disease control in a subset of filgotinib-treated individuals.ClinicalTrials.gov identifier: NCT02914522.
溃疡性结肠炎（UC）影响患者的健康相关生活质量（HRQoL）。我们在SELECTION 试验中评估了接受 filgotinib（一种口服 JAK1 选择性抑制剂）治疗的个体的 HRQoL 和探索性患者层面综合终点（“综合疾病控制”[CDC]）。
在 SELECTION 试验[NCT02914522]中，一项双盲、随机、安慰剂对照、2b/3 期试验，中度至重度活动期 UC 患者接受每日一次 filgotinib 200mg、filgotinib 100mg 或安慰剂治疗 11 周，在诱导研究 A（生物初治）或 B（生物经验丰富）中进行。在第 10 周临床缓解/反应的 filgotinib 应答者被重新随机分配至他们的 filgotinib 方案或安慰剂进行 48 周的维持研究。我们评估了第 10 周和第 58 周的 SF-36、EQ-5D、WPAI 和 IBDQ 评分。还探索了达到 CDC（患者层面部分 Mayo 评分[PMSC]缓解[PMSC≤2，无个体直肠出血、粪便频率或医生整体评估子评分>1]、内镜改善[内镜子评分≤1]、粪便钙卫蛋白<150μg/g 和 IBDQ 评分≥170）及其与 HRQoL 和组织学结局的关系。
分析包括 382 名生物初治和 404 名生物经验丰富的患者。与安慰剂相比，filgotinib 200mg 在第 10 周和第 58 周诱导和维持了 SF-36、EQ-5D、WPAI 和 IBDQ 评分的改善，并在第 10 周恢复了 HRQoL。与安慰剂相比，更多的 filgotinib 200mg 治疗患者在第 10 周和第 58 周达到了 CDC（P<0.01）。CDC 与两个时期 HRQoL 和组织学缓解的临床重要改善相关。
Filgotinib 200mg 可在短期内和长期内改善 HRQoL。高水平的 HRQoL 改善与严格的综合终点相关，提示在接受 filgotinib 治疗的个体中存在有意义的疾病控制。
NCT02914522。
