In a new analysis of Phase 2 and 3  anifrolumab (Saphnelo®) clinical trial data, researchers found that the SLE Disease Activity Score (SLE-DAS) Responder Index (RI) is a valid and sensitive tool  to measure treatment response in people living with systemic lupus erythematosus (SLE). Developed as a clinical outcome measure, the SLE-DAS RI helps determine whether treatments are making a meaningful difference in an individual’s disease. The tool uses a more stringent definition of response by requiring clear improvement from baseline, reduction in disease activity, and an overall reduction in disease burden.

Researchers conducted a post-hoc analysis of participants from three randomized controlled trials of anifrolumab (MUSE, TULIP-1, and TULIP-2). About 34% of participants met the response criteria after one year, and those individuals showed greater reductions in disease activity, used fewer steroids, and reported better quality of life. Notably, SLE-DAS RI response was associated with  improvements in health-related quality of life across multiple domains, reinforcing its value as a patient-centered measure of treatment success.

Overall, the findings show that the SLE-DAS RI is a robust and promising endpoint for use in clinical trials, associated with sustained disease control and meaningful improvements in self-reported outcomes. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about SLE.

Read the study