Impact of rituximab on patient-reported outcomes in patients with rheumatoid arthritis from the US Corrona Registry

Leslie R Harrold,Joel M Kremer,Ani John,Chitra Karki,Steve Zlotnick,Youfu Li,Jeffrey D Greenberg,Jennie Best

doi:10.1007/s10067-017-3742-2

Abstract

To evaluate the impact of rituximab on patient-reported outcomes (PROs) in a US-based observational cohort of patients with rheumatoid arthritis (RA). Patients with active RA, prior exposure to ≥1 tumor necrosis factor inhibitor (TNFi) and who newly initiated rituximab were identified. Changes in PROs were assessed 1 year after rituximab initiation. PRO measures included Clinical Disease Activity Index (CDAI); patient global disease activity, pain and fatigue (visual analog score; 0–100); morning stiffness (hours); modified Health Assessment Questionnaire (mHAQ; 0–3); and EuroQoL EQ-5D. Of the 667 patients who newly initiated rituximab, baseline PRO and clinical measures indicated that patients were substantially impacted by their RA disease and quality of life; 54% of patients had high disease activity. One year after rituximab initiation, 49.0, 47.1, 49.8, and 23.2% of patients reported clinically meaningful improvements in patient global, pain, fatigue, and mHAQ, respectively. Morning stiffness and EuroQol EQ-5D domains improved in 48 and 19–32% of patients, respectively. These real-world registry data demonstrated that patients with long-standing, refractory RA experienced improvements in PROs 1 year after initiating rituximab.

Highlights

Patients with rheumatoid arthritis (RA) often experience reduced health-related quality of life (HRQOL), including disability and RA-related comorbidities [1, 2]
All patients had previously received ≥1 tumor necrosis factor inhibitor (TNFi) and had low, moderate, or high disease activity based on Clinical Disease Activity Index (CDAI), defined as CDAI >2.8
Patient-reported outcomes (PROs) were assessed at 1 year and included the median change from baseline and the proportion of patients reporting minimum clinically important differences (MCIDs; defined as improvement of ≥10) in patient global assessment of disease, pain, and fatigue (0–100 on a visual analog scale) [8]; improvement in morning stiffness; proportion of patients achieving a clinically meaningful improvement in modified Health Assessment Questionnaire, defined as a decrease of >0.25 from baseline in the mHAQ score [9]; and improvement in the EuroQol EQ-5D overall health status index, which records patient-reported HRQOL across five domains

Summary

Introduction

Patients with rheumatoid arthritis (RA) often experience reduced health-related quality of life (HRQOL), including disability and RA-related comorbidities [1, 2]. Patient-reported outcomes (PROs) include HRQOL indices, such as the ability to perform day-to-day tasks, emotional health, and the degree of pain and discomfort. PROs are increasingly being recognized as important measures in determining response to therapy in patients with RA [3,4,5]. Rituximab is a monoclonal antibody that targets and depletes CD20+ B cells and, in combination with methotrexate, is approved for the treatment of RA in patients who have had an inadequate response to ≥1 tumor necrosis factor inhibitor (TNFi).

Methods

Results

Conclusion