Background/Purpose:

Patient reported outcomes measures (PROMs) are changing the landscape in rheumatology care. Electronic PROMs (ePROMs) is a new patient-centric model of collaboration that fully engages patients in the decision making and governance to optimize controlling their disease activity and its management.

Objectives. To assess the value of ePROMs in the assessment and management of SLE disease activity flares observed over a 24-month period; its association with adherence to therapy as well as organ damage adjusted for potential confounding factors.

Methods:

A randomized, controlled crossover study carried out over 24-month duration. 147 SLE patients meeting the revised ACR criteria were enrolled. Disease activity was assessed using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) whereas organ damage was scored using the SLICC/ACR Damage Index (SDI). In the first 12-month, the patients were assessed once every 3-months. Prior to their assessment in the clinic, each patient completed a PROMs questionnaire (paper format) [1]. Flare was defined as an increase ≥4 points in the SLEDAI between two clinic visits. At 12-months, the patients were randomized into a cohort of 73 patients who continued their care in the same style and 74 patients who completed an online ePROMs questionnaire on monthly basis for another 12-month period. The patients were given an appointment in an SLE hot clinic should their SLEDAI shows an increase of more than three points, management was adjusted accordingly. Otherwise every patient was seen every 3-months. The data captured were then retrospectively analysed at the end of the 24-month study period to determine the association between the number of flares and damage accrual. Adherence to therapy was also assessed at the end of the study.

Results:

At the end of the first year of the study, the mean of SLEDAI and SDI were 8.72 (6.1) and 1.9 (2.2) respectively. At the end of the second year the mean SLEDAI and SDI in the ePROMs cohort was 3.1 (2.6) and  1.2 (1.3) respectively, whereas in the control group the SDI an SLEDAI mean was 7.63 (6.7) and 1.8 (2.3) respectively (p< 0.01). Adjusting for possible confounding variables, the number of flares, regardless of their severity, was associated with damage accrual (OR 2.03, 95% CI 1.34 to 2.83, p<0.001). Adherence to therapy was significantly (p<0.1) higher in the ePROMs group whereas stopping DMARDs for intolerability was significantly (p<0.01) higher in the control group at 24-months of treatment.

Conclusion:

ePROMs has a potential disease modifying effect as it facilitated close monitoring of disease activity with an option of management escalation whenever indicated. Disease activity as measured by SLEDAI over a 24-month observation period predicted the risk of subsequent organ damage independently of other known risk factors.

Reference:

1. El Miedany Y et al. Ann Rheum Dis 2013; 72(Suppl3):484

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/electronic-patient-reported-outcome-measures-in-systemic-lupus-erythematosus-a-potential-disease-modifying-impact-on-the-management-of-disease-activity-flares-and-damage-accrual/