Characterize disease activity

The Progentec aiSLE® DX Lupus Disease Activity Index assay characterizes patients with active clinical and/or serologic disease versus patients with low or quiescent disease. The well-defined set of 10 biomarkers measured in this assay encompasses the breadth of immune dysregulation associated with SLE and reflects the immune status of individual patients. Results from this test can be used to help determine the necessary frequency of clinical assessments, guide clinical disease management, and evaluate early response to treatment.

Key testing

• LDAI | Progentec aiSLE® DX Lupus Disease Activity Index, Plasma

Advantages

• Algorithm provides a composite index score that differentiates current disease activity into low, moderate, and active states.
• Achieves up to 95% specificity and 100% sensitivity for low, medium, and high risk index thresholds for active disease determined by decision curve analysis. Can be used to assess need for more frequent clinical evaluations in SLE patients with medium to high DAI scores.
• Supports clinical evaluation in patients with heightened disease activity.
• Assists with treatment management by clarifying medication compliance, monitoring dial-down therapies, and enabling steroid-sparing interventions.

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Predict disease flares

The Progentec aiSLE® DX Lupus Flare Risk Index quantifies pro-inflammatory and regulatory immune soluble mediators to calculate a flare risk index, which assigns an individuals score associated with a patient's risk of a forthcoming flare. The index score reported for the test predicts the risk of clinical disease flare over the next 12 weeks.

Key testing

• LFRI | Progentec aiSLE® DX Lupus Flare Risk Index, Plasma

Advantages

• Predicts mild, moderate, severe, or no flare prior to flare occurrence.
• Uses a scientist-developed, weighted algorithm to calculate a flare risk index, which assigns an individual score associated with a patient’s risk of a forthcoming flare.
• Achieves up to 97% sensitivity and 98% specificity for low, medium, and high flare risk index thresholds determined by decision curve analysis.

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References

1. Hammond ER, Desta B, Near AM, Wang X, Jiang M. Frequency, severity and costs of flares increase with disease severity in newly diagnosed systemic lupus erythematosus: a real-world cohort study, United States, 2004-2015. Lupus Sci Med. 2021 Sep;8(1):e000504. doi:10.1136/lupus-2021-000504. PMID: 34556546; PMCID: PMC8461688.
2. Adamichou C, Bertsias G. Flares in systemic lupus erythematosus: diagnosis, risk factors and preventive strategies. Mediterr J Rheumatol. 2017 Mar 28;28(1):4-12. doi:10.31138/mjr.28.1.4. PMID: 32185248; PMCID: PMC7045928.
3. Zen M, Saccon F, Gatto M, Montesso G, Larosa M, Benvenuti F, Iaccarino L, Doria A. Prevalence and predictors of flare after immunosuppressant discontinuation in patients with systemic lupus erythematosus in remission. Rheumatology (Oxford). 2020 Jul 1;59(7):1591-1598. doi:10.1093/rheumatology/kez422. PMID: 31642908.
4.    Munroe M, Blankenship D, DeFreese D, Holloway A, Purushothaman M, DeJager W, Macwana S, Guthridge J, Kamp S, Redinger N, Aberle T, Chakravarty E, Arriens C, Li Y, Zeng H, Dezzutti S,Izmirly P, Thanarajasingam U, Kamen D, Buyon J, James J, Jupe E. A refined disease activity immune index informed by select immune mediators that characterizes clinical disease activity in systemic lupus erythematosus [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9).
5.    Munroe M, DeJager W, Macwana S, Tran L, Guthridge J, Jupe E, DeFreese D, Newhardt R, Purushothaman M, Sharma S, Redinger N, Aberle T, Kamp S, Arriens C, Chakravarty E, Merrill J, James J. Ability of innate, adaptive, and TNF-superfamily immune pathways to characterize disease activity and inform a refined lupus disease activity immune index in a confirmatory cohort of SLE patients [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10).
6.    Munroe M, Guthridge J, Lu R, Kheir J, Adebayo B, Macwana S, Chen H, Roberts VC, Purushothaman M, Sharma S, Aberle T, Kamp S, Arriens C, Chakravarty E, Thanou K, Merrill JT, James JA. Innate, adaptive, and TNF-Superfamily immune pathways inform a lupus disease activity immune index that characterizes disease activity in SLE [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9).
7. Munroe ME, Blankenship D, DeFreese D, Purushothaman M, DeJager W, Macwana S, Guthridge JM, Kamp S, Redinger N, Aberle T, Chakravarty EF, Arriens C, Li Y, Zeng H, McCarthy-Fruin KA, Osei-Onomahm S-A, Thanarajasingam U, James JA, Jupe E. (2023), A Flare Risk Index Informed by Select Immune Mediators in Systemic Lupus Erythematosus. Arthritis Rheumatol, 75: 723-735. https://doi.org/10.1002/art.42389.
8. Thanou A, Jupe E, Purushothaman M, Niewold TB, Munroe ME. Clinical disease activity and flare in SLE: Current concepts and novel biomarkers. Journal of Autoimmunity. Volume 119. 2021, 102615, ISSN 0896-8411. https://doi.org/10.1016/j.jaut.2021.102615.
9. Munroe ME,Vista ES, Merrill JT, Guthridge JM, Roberts VC, James JA. (2017), Pathways of impending disease flare in African-American systemic lupus erythematosus patients. J Autoimmun. 78:70-78. PMCID: PMC5340190.
10. Munroe ME, Vista ES, Guthridge JM, Thompson LF, Merrill JT, James JA. (2014), Pro-inflammatory adaptive cytokines and shed tumor necrosis factor receptors are elevated preceding systemic lupus erythematosus disease flare. Arthritis Rheumatol, 66(7):1888-99. PMCID: PMC4128244.