Validation of SLE Virtual Outcome Measures

Systemic lupus erythematosus (SLE), also known as lupus, is a whole-body autoimmune disease that affects an estimated 270,000 Americans. Lupus syndromes include incomplete lupus and cutaneous (skin) lupus and affect upward of one million people; the current application is about systemic lupus. SLE has high costs in lost work, relationships, and years of productive life. Joint pains, fatigue, and rashes are the most common symptoms of SLE, affecting a majority of patients. SLE requires frequent monitoring and visits to doctors. Unfortunately, despite numerous potential drugs that failed clinical trials, there are only four Food and Drug Administration-approved therapies for the management of SLE. This lack of new approved SLE medications means that doctors must find even better ways to use the current drugs.

Recently, during the COVID-19 pandemic, more and more rheumatology practices have either offered or entirely switched to telemedicine visits to reduce COVID-19 exposure risk for both patients and providers. As a result, many clinic visits are still being conducted remotely. Additionally, most clinical trials paused enrollment, and the majority of their active enrolled subjects were seen and assessed over telemedicine visits. Since there has been almost no research on telemedicine evaluation of lupus patients, rheumatologists and researchers who specialize in SLE have struggled with how to accurately evaluate the disease over video telemedicine visits. The goal of this proposal is to validate a version of already existing SLE disease measures for doctors to use in telemedicine visits.

The first aim of this study is to evaluate SLE disease activity measures obtained via telemedicine, using a teleconference video platform. We will enroll 200 SLE patients with different levels of disease activity from multiple sites around the United States to evaluate and refine virtual SLE outcome measures. Each subject will first be seen by the same doctor twice: first on a video platform visit and then at in-person follow-up visit on the same day. SLE disease activity measures will be completed by that doctor immediately after each encounter, and subsequently finalized when lab results become available. Physicians and patients will provide feedback. The degree of agreement between the virtual and in-person disease activity measures will be assessed. After the first 50 subjects are enrolled, we will analyze the results to fine-tune the virtual assessments.

In the second aim, we will evaluate the association between patient related-factors and the accuracy of the virtual SLE disease activity measures. We will examine disease activity and demographic socioeconomic variables (race, ethnicity, sex, education, insurance, zip code) – as well as patient-reported outcome measures for pain, fatigue, and mood – on the degrees of agreement between the virtual and face-to-face disease activity measures.

The third aim is to evaluate how sensitive these virtual disease activity measures are to change. The subjects will then be examined on another day at both a virtual and in-person follow-up visit to assess the sensitivity to change between the baseline and follow-up visits of the virtual disease activity measures, compared to the face-to-face disease activity measures.

This proposal addresses the challenges of evaluating disease activity and response to therapy using telemedicine, given the heterogeneity of SLE. The aims will provide essential data to allow doctors to use virtual outcome measures to assess disease activity in SLE and improve access to care for SLE patients. Based upon our findings, we hope to expand virtual outcomes in SLE to clinical practices, lupus research, and clinical trials. Ultimately, we hope to bring the best quality of care to people's homes as opposed to bringing SLE patients to medical facilities for their care.