Toward clinically actionable lupus biomarkers: a roadmap for research, validation, and translation.

Despite advances in lupus biomarker research, clinical translation has remained limited, leading to delayed diagnosis, imprecise disease monitoring, and trial-and-error treatment approaches. This roadmap, developed by the Lupus Research Alliance's Biomarker Roadmap Committee with input from patients and experts, identifies key priorities for translating research into clinical benefit. Three major clinical unmet needs are highlighted: improving diagnostic accuracy of Systemic Lupus Erythematosus (SLE) and neuropsychiatric SLE, developing sensitive longitudinal markers for disease activity (including lupus nephritis), and predicting disease progression and treatment response. We review the current state of biomarker development across these domains and highlight barriers that hinder clinical validation, assay development, and clinical adoption. We propose focused strategies to overcome these challenges, emphasizing analytically validated assays, diverse longitudinal cohorts, alignment with meaningful clinical outcomes, and consortium-based efforts. The roadmap outlines a path to transform lupus diagnosis, monitoring, and precision medicine, enabling research advances to improve patient care.