Improving Clinical Management and Patient-Reported Outcomes Among Patients with Rheumatoid Arthritis in China via Real-world Evidence (IMPROVE Study): A Multicenter Prospective Cohort Study

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-04-29 DOI:10.1007/s12325-025-03179-7

Nan Jiang, Dongzhou Liu, Xinwang Duan, Lijun Wu, Yi Liu, Hao Zhu, Yanjie Zhang, Mengtao Li, Xinping Tian, Xiaofeng Zeng

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Abstract

Introduction

Patient-reported outcomes (PROs) help to understand rheumatoid arthritis (RA) from patients’ perspective and play an important role in RA management. This study aims to describe the PRO changes over 6 months among patients with RA in China and explore the relationships between PROs and RA disease activity.

Methods

This multicenter prospective cohort study enrolled patients with RA aged ≥ 18 years. At enrollment, patients were dichotomized into remission/low disease activity (LDA) and moderate-to-high disease activity (MDA/HDA) based on Disease Activity Score-28 with C-Reactive Protein (DAS28-CRP). Only patients with MDA/HDA (DAS28-CRP ≥ 3.2) were followed for 6 months. PROs included pain, fatigue, morning stiffness, Patients’ Global Assessment (PtGA), disability, work productivity, and activity impairment. Disease activity measures included DAS28-CRP, DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI).

Results

A total of 872 patients were enrolled: 520 patients in remission/LDA and 352 in MDA/HDA. In MDA/HDA patients, pain decreased significantly from enrollment at month 1 (p < 0.0001), month 3 (p < 0.0001), and month 6 (p = 0.0094). Fatigue improved significantly at month 3 (p = 0.0073). Other PROs, including morning stiffness, PtGA, disability, work productivity, and activity impairment, also improved. Patients who achieved remission/LDA had significant faster decline in pain, fatigue, PtGA, and work productivity compared to those who did not. Pain was positively correlated with disease activity measures at months 1, 3, and 6, while fatigue was positively associated with disease activity measures at months 3 and 6 only. Morning stiffness, PtGA, and disability correlated with disease activity at months 1 and 3.

Conclusions

Patients with RA with MDA/HDA in China experienced significant improvement in pain and fatigue over 6 months. Improvement in DAS28-CRP was associated with faster improvement in certain PROs. While disease activity correlated with some PROs, they did not fully capture patient experience, highlighting the importance of PROs in RA management.

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通过真实世界证据改善中国类风湿关节炎患者的临床管理和患者报告的结果（改进研究）：一项多中心前瞻性队列研究。

患者报告结局（pro）有助于从患者的角度了解类风湿关节炎（RA），并在RA的治疗中发挥重要作用。本研究旨在描述中国RA患者6个月内PRO的变化，探讨PRO与RA疾病活动度的关系。方法：这项多中心前瞻性队列研究纳入了年龄≥18岁的RA患者。在入组时，根据c -反应蛋白（DAS28-CRP）的疾病活度评分-28分，将患者分为缓解/低疾病活度（LDA）和中高疾病活度（MDA/HDA）。仅MDA/HDA （DAS28-CRP≥3.2）患者随访6个月。优点包括疼痛、疲劳、晨僵、患者整体评估（PtGA）、残疾、工作效率和活动障碍。疾病活动性指标包括DAS28-CRP、das28 -红细胞沉降率（DAS28-ESR）、临床疾病活动性指数（CDAI）和简化疾病活动性指数（SDAI）。结果：共纳入872例患者：缓解/LDA患者520例，MDA/HDA患者352例。在MDA/HDA患者中，疼痛在入组后第1个月显著减少(p)。结论：在中国，MDA/HDA患者在6个月内疼痛和疲劳有显著改善。DAS28-CRP的改善与某些pro的更快改善相关。虽然疾病活动与一些PROs相关，但它们并不能完全反映患者的经验，这突出了PROs在RA管理中的重要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.