Willian Mary Kaye, D'Haens Geert, Yarlas Aaron, Joshi Ashish V
1Shire, 725 Chesterbrook Blvd, Wayne, PA 19087 USA.
2Inflammatory Bowel Disease Centre, Academic Medical Centre, University of Amsterdam the Netherlands, Meibergdreef, 91105 AZ Amsterdam, The Netherlands.
J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.
Ulcerative colitis (UC) is associated with lower health-related quality of life (HRQoL), and with disease activity predicting lower HRQoL and worse work-related outcomes. The current study examined the burden of UC on patients' HRQoL, as well as changes in patients' HRQoL and work-related outcomes following short-term and long-term treatment with multimatrix mesalamine, and their correspondence with changes in disease activity.
Data were from an open-label, multinational, prospective trial (ClinicalTrials.gov identifier: NCT01124149) of 717 adults with active mild-to-moderate UC who were treated with 4.8 g/day multimatrix mesalamine tablets once daily for eight weeks (acute phase). Four-hundred sixty-one patients who achieved partial or complete clinical and endoscopic remission subsequently received treatment with daily 2.4 g/day multimatrix mesalamine for 12 months (maintenance phase). At baseline, Week 8, and Month 12, patients were administered patient-reported outcomes (PRO) measures of HRQoL (the SF-12v2® Health Survey [SF-12v2] and Short Inflammatory Bowel Disease Questionnaire) and work-related outcomes (Work Productivity and Activity Impairment questionnaire, UC-specific version). SF-12v2 scores were compared to the U.S. general population using Analysis of Variance models to assess burden of UC on HRQoL. Mixed-effects repeated-measures models compared PRO scores across visits to assess change in PRO scores over time. Correlations examined the correspondence of changes in PRO scores with changes on a modified UC disease activity index (UC-DAI).
Baseline burden of disease observed on all SF-12v2 domains was partially eliminated at Week 8 and completely eliminated at Month 12. Statistically significant improvements from baseline were observed at both Week 8 and Month 12 for all PRO scores (all < 0.001). Decreases in UC-DAI scores significantly predicted improvements in PRO scores during the acute treatment phase.
Patients with UC receiving daily multimatrix mesalamine treatment showed significant improvements in all measured domains of HRQoL and work-related outcomes. Patients who achieved partial or complete clinical and endoscopic remission maintained these improvements for most of these domains over 12 months with continued daily treatment. Changes in HRQoL and work-related outcomes were inversely related to changes in disease activity. Findings support the effectiveness of multimatrix mesalamine for improving, and sustaining improvements, in HRQoL and work-related outcomes.
溃疡性结肠炎（UC）与健康相关生活质量（HRQoL）较低有关，且疾病活动度可预测较低的HRQoL和较差的工作相关结局。本研究调查了UC对患者HRQoL的负担，以及多矩阵美沙拉嗪短期和长期治疗后患者HRQoL和工作相关结局的变化，及其与疾病活动度变化的相关性。
数据来自一项开放标签、多国、前瞻性试验（ClinicalTrials.gov标识符：NCT01124149），717例轻度至中度活动性UC成年患者接受每日4.8 g多矩阵美沙拉嗪片治疗，为期8周（急性期）。461例实现部分或完全临床及内镜缓解的患者随后接受每日2.4 g多矩阵美沙拉嗪治疗12个月（维持期）。在基线、第8周和第12个月，对患者进行HRQoL的患者报告结局（PRO）测量（SF-12v2®健康调查[SF-12v2]和简短炎症性肠病问卷）以及工作相关结局（工作效率和活动障碍问卷，UC特定版本）。使用方差分析模型将SF-12v2评分与美国普通人群进行比较，以评估UC对HRQoL的负担。混合效应重复测量模型比较各访视间的PRO评分，以评估PRO评分随时间的变化。相关性分析检查了PRO评分变化与改良UC疾病活动指数（UC-DAI）变化的对应关系。
在第8周时，所有SF-12v2领域观察到的基线疾病负担部分消除，在第12个月时完全消除。在第8周和第12个月时，所有PRO评分均较基线有统计学显著改善（均P<0.001）。在急性治疗阶段，UC-DAI评分的降低显著预测了PRO评分的改善。
接受每日多矩阵美沙拉嗪治疗的UC患者在HRQoL和工作相关结局的所有测量领域均有显著改善。实现部分或完全临床及内镜缓解的患者在持续每日治疗的情况下，在12个月内大部分领域维持了这些改善。HRQoL和工作相关结局的变化与疾病活动度的变化呈负相关。研究结果支持多矩阵美沙拉嗪在改善和维持HRQoL及工作相关结局方面的有效性。
