# The Association of Anti-dsDNA Antibodies with Patient-reported Outcomes of Patients with Systemic Lupus Erythematosus in a Two-consecutive Year Prospective Study

## TL;DR

This study found that anti-dsDNA antibodies are not strongly linked to patient-reported outcomes in lupus patients over time.

## Contribution

The study is the first to prospectively analyze the relationship between anti-dsDNA and PROs in SLE patients over two years.

## Key findings

- Anti-dsDNA showed weak correlation with physician-assessed disease activity but not with patient-reported symptoms.
- Changes in anti-dsDNA levels did not correlate with changes in patient-reported outcomes over short or long-term periods.
- Objective lab measures may be needed to better capture patient-reported outcomes in SLE.

## Abstract

To analyse the association of anti-dsDNA Ab with patient-reported outcomes (PROs) in patients with SLE under maintenance treatment, as it has not been clearly understood whether PROs are able to be reflected by anti-dsDNA, which are associated with SLE activities (SLE Disease Activity Index 2000, SLEDAI-2K).

The SLE symptom checklist (SSC), LupusPRO, Medical Outcomes Study Short Form-36 (SF-36), and patient and physician visual analogue scale (Pt/Ph-VAS) at a time point were evaluated for correlation with anti-dsDNA using the Kyoto Lupus Cohort Registry (n = 310) from 2019 to 2020. Further, associations between changes in anti-dsDNA with those in Pt/Ph-VAS and SSC at two time points of short-term (3 months) or long-term (2 years) time points.

Cross-sectionally, anti-dsDNA slightly correlated with Ph-VAS (ρ = 0.18, p = 0.003) and SLEDAI-2K (ρ = 0.14, p = 0.03), while anti-dsDNA was not correlated with SSC, SF-36, and LupusPRO, or Pt-VAS. In short-term and long-term, anti-dsDNA demonstrated no significant correlation with alterations in SSC, Pt-VAS, or Ph-VAS. Further, they did not show associations when SLE activities (SLEDAI-2K) were worsened.

PROs at a time point and changes were difficult to be captured by anti-dsDNA. It is desirable to explore objective laboratory measures to evaluate PROs.