一项使用移动应用程序评估乌帕替尼治疗类风湿关节炎早期疗效的真实世界有效性研究。

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis.

作者信息

Harrold Leslie R, Zueger Patrick, Nowell W Benjamin, Blachley Taylor, Schrader Amy, Lakin Paul R, Curtis David, Stradford Laura, Venkatachalam Shilpa, Tundia Namita, Patel Pankaj A

机构信息

CorEvitas, LLC, 300 5th Avenue, Waltham, MA, 02451, USA.

University of Massachusetts Medical School, Worcester, MA, USA.

出版信息

Rheumatol Ther. 2023 Dec;10(6):1519-1533. doi: 10.1007/s40744-023-00594-6. Epub 2023 Sep 20.

DOI:10.1007/s40744-023-00594-6

PMID:37728861

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10654297/

Abstract

INTRODUCTION

The impact of upadacitinib on rheumatoid arthritis (RA) symptoms was evaluated during the first 12 weeks of treatment via patient-reported outcomes (PROs) using a mobile health application (app).

METHODS

Participating rheumatologists from the CorEvitas RA Registry (prospective, observational cohort) recruited patients with RA initiating upadacitinib treatment. A modified version of the ArthritisPower® app was used to collect PROs, including the Routine Assessment of Patient Index Data 3 (RAPID3), duration of morning joint stiffness, and the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue 7a Short Form at baseline and weeks 1-4, 8, and 12. RAPID3 responses over time were assessed using Kaplan-Meier estimation to determine the proportion of patients achieving disease activity improvement and minimal clinically important difference (MCID). Results were analyzed for all patients initiating upadacitinib and a subsample of TNF inhibitor (TNFi)-experienced patients with moderate to severe disease at baseline.

RESULTS

A total of 103 patients with RA initiating upadacitinib (62.1% TNFi-experienced) were included. At week 12, 53 patients (51.4%) completed the study and provided PRO data via the app. Among all patients, improvements in RAPID3, pain, morning stiffness, and fatigue were observed at week 1 and were maintained or further improved through week 12. At week 12, 37.5% of patients achieved RAPID3 low disease activity. Starting at week 1, improvements in RAPID3 disease activity category (19.4% of patients) and achievement of MCID (16.3%) were reported, with nearly 50% of patients achieving these outcomes by week 4 (RAPID3 category: 48.8%; MCID: 49.2%) and 60% by week 12 (RAPID3 category: 59.6%; MCID: 59.8%). TNFi-experienced patients generally reported similar outcomes. Patient-reported medication convenience and compliance were generally high.

CONCLUSIONS

In this real-world cohort of patients with RA, treatment with upadacitinib was associated with early and significant improvement in RAPID3, pain, morning stiffness, and fatigue regardless of prior TNFi experience. Clinically meaningful improvement in RAPID3 patient-reported disease activity was observed as early as week 1, with continued improvement reported through week 12.

摘要

引言

在治疗的前12周内，通过使用移动健康应用程序（app）的患者报告结局（PRO）评估了乌帕替尼对类风湿性关节炎（RA）症状的影响。

方法

来自CorEvitas RA注册中心（前瞻性观察队列）的参与研究的风湿病学家招募了开始使用乌帕替尼治疗的RA患者。使用ArthritisPower®应用程序的修改版收集PRO，包括患者指数数据3的常规评估（RAPID3）、晨僵持续时间，以及在基线、第1 - 4周、第8周和第12周时的患者报告结局测量信息系统（PROMIS）-疲劳7a简表。使用Kaplan-Meier估计法评估随时间变化的RAPID3反应，以确定达到疾病活动改善和最小临床重要差异（MCID）的患者比例。对所有开始使用乌帕替尼的患者以及基线时患有中度至重度疾病的TNF抑制剂（TNFi）经验丰富的患者子样本进行结果分析。

结果

总共纳入了103例开始使用乌帕替尼的RA患者（62.1%有TNFi使用经验）。在第12周时，53例患者（51.4%）完成了研究并通过应用程序提供了PRO数据。在所有患者中，第1周时观察到RAPID3、疼痛、晨僵和疲劳有所改善，并在第12周时保持或进一步改善。在第12周时，37.5%的患者达到RAPID3低疾病活动度。从第1周开始，报告了RAPID3疾病活动类别改善（19.4%的患者）和达到MCID（16.3%）的情况，到第4周时近50%的患者达到这些结果（RAPID3类别：48.8%；MCID：49.2%），到第12周时为60%（RAPID3类别：59.6%；MCID：59.8%）。有TNFi使用经验的患者通常报告了类似的结果。患者报告的药物便利性和依从性普遍较高。