A groundbreaking study may revolutionize the diagnosis of lupus nephritis (LN) by unveiling unique microRNAs (miRNAs) in the blood serum of systemic lupus erythematosus (SLE) patients with LN. As vital regulators of gene expression, miRNAs show promise as potential predictors for LN in SLE patients, offering a more efficient alternative to current diagnostic methods involving proteinuria quantification and kidney biopsy. These findings not only address unmet needs in LN diagnosis but also pave the way for innovative treatments targeting these biomarkers, says GlobalData, a leading data and analytics company.

The current methods of LN diagnosis include proteinuria quantification and kidney biopsy, which are time-consuming and challenging to conduct. The recent set of results has the potential to have direct implications in the diagnosis landscape of LN in SLE patients.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “Biomarkers have always been a topic that draw the attention of researchers. The results of this clinical study by Yang et al., that was conducted in China in 2023, may be promising for the field of LN diagnosis, a field in which the diagnosis is challenging, as it is heavily dependent on biopsies. With the identification of such unique RNAs, patients with LN may be able to be diagnosed more efficiently.”

The study which identified two exosomal miRNAs (hsa-miR-4796-5p and hsa-miR-7974) at high levels in SLE patients with LN, compared to SLE patients without LN (1.5-fold difference for both miRNAs), proposed a predictive role of these biomarkers in the diagnosis of LN in patients with SLE.

Maniatis explains: “The treatment landscape may also be benefited through this identification, as RNAs may be used as targets for future advanced therapies against LN in SLE patients. Currently, multiple drugs have been approved for use against LN including Roche’s Rituxan (rituximab) (Japan), Astellas’ Prograf (tacrolimus) (Japan), Aurinia Pharmaceuticals’ Lupkynis (voclosporin) (EU, US), and GlaxoSmithKline’s Benlysta (belimumab) (EU, US), with glucocorticoids and immunosuppressants being the primary therapies for the initial stages of disease progression.”

Biomarkers may be able to transform LN diagnosis, therefore their further investigation is significant. GlobalData identifies the top 10 biomarker types that are targeted in current clinical trials for LN, including anti-double stranded DNA antibodies, the complement component 3, and creatinine.

Maniatis concludes: “The identification of new predictive biomarkers for LN in SLE patients may allow the development of advanced therapies in LN which are urgently needed. As demonstrated by GlobalData’s analysis, the competition in the market is high, which further highlights the market opportunity in the field of LN diagnosis and treatment.”