Abstract
Systemic lupus erythematosus (SLE) is a disorder that is heterogeneous and can be difficult to diagnose. A new classification system was created by a group funded by EULAR / ACR that proposes using ANA positivity as an entry criterion for diagnosis of SLE, without which patients cannot qualify as having SLE. In this study, we use a database of cutaneous lupus erythematosus (CLE) patients to determine how many have a negative ANA and meet criteria for SLE using ACR and/or SLICC criteria. We used a database of 453 CLE patients that contained information including ANA status and the presence of features of SLE. The database was searched for patients who had a negative ANA and whether or not they met SLE criteria using the ACR and/or SLICC criteria. Of the 405 active patients with a known ANA, 153 had a negative ANA (37.78%) and 14 had an ANA that fluctuated (3.46%). 26 ANA negative patients met SLE criteria (16.99%) and 10 patients with fluctuating ANA met SLE criteria (71.43%). Of all patients either having a negative ANA or a fluctuating ANA and meeting criteria for SLE (n = 35), 31 patients had involvement of at least 1 organ system other than skin (88.57%), and 15 patients had involvement of at least 2 organ systems other than skin (42.85%). Of the 31 patients with non-mucocutaneous organ involvement, 28 patients had arthritis, 11 patients had leukopenia, 4 patients had renal involvement, 4 patients had serositis, 2 patients had neurologic involvement, and 1 patient had thrombocytopenia. Our results show that a significant number of CLE patients with a negative ANA have disease involvement of non-mucocutaneous organ systems. Using ANA positivity as an entry criterion for a diagnosis of SLE may exclude patients with significant systemic disease from receiving appropriate treatment.
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