Susan Manzi, MD, MPH, co-director of the Lupus Center of Excellence and Chair of the Department of Medicine of West Penn Hospital, Allegheny Health System, Pittsburgh, led the discussion of lupus diagnosis and treatment in 2019. This year is of note in the world of lupus because the ACR and EULAR have published recommendations for systemic lupus erythematosus (SLE) classification criteria, and this publication uses a positive anti-nuclear antibody (ANA) in a titer of ≥1:80 as a required entry criterion.
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The panel specifically recommends testing by immunofluorescence on human epithelial type 2 (HEp-2) cells or a solid phase ANA screening immunoassay with equivalent performance. By using a combination of clinical and immunologic criteria for which there is not a better explanation than SLE, these classification criteria have demonstrated excellent sensitivity and specificity compared with the sensitivity and specificity of ACR 1997 and Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) 2012 criteria for SLE classification (96.1% and 93.4%, 82.8% and 93.4%, 96.7% and 83.7%, respectively).10
Dr. Manzi also pointed out that one of the most exciting areas of new research in lupus is the Accelerating Medicines Partnership (AMP) program, a collaboration between the National Institutes of Health (NIH), pharmaceutical companies and nonprofit organizations meant to develop new ways of identifying and validating promising biological targets for diagnostics and drug development.
In this vein, a 2017 article described the way single-cell RNA sequencing (scRNA-seq) was used in renal and skin biopsy tissue from patients with lupus.11 One of the key findings in this study was that cumulative expression profiles of single cell keratinocytes from nonlesional, non-sun-exposed skin of patients with lupus nephritis showed upregulation of interferon (IFN) inducible genes compared with keratinocytes isolated from healthy controls, indicating the possibility of using scRNA-seq analysis of skin biopsies as a biomarker of renal disease.
The AMP study groups have undertaken many ongoing studies that seek to further expand knowledge in the fields of lupus and rheumatoid arthritis, and the rheumatology community hopes results from these studies will aid in understanding the pathogenesis of these conditions, help identify surrogate markers for disease activity, and perhaps better classify subpopulations of patients within these broader disease categories.
Finally, on the subject of IFN gene signatures and the role that IFN may play in the pathophysiology of lupus, Dr. Manzi did point out that anifrolumab, a monoclonal antibody against the type I IFN receptor, met the primary endpoint (British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52) in the phase 3 TULIP 2 trial after failing to meet the primary endpoint (SLE Responder Index 4, or SRI4) in the phase 3 TULIP 1 trial.12