Tarazi M, et al. - A database of 301 biopsy-proven cutaneous lupus erythematosus (CLE) patients was examined to assess how many of these patients have a negative antinuclear antibodies (ANA) and meet criteria for systemic lupus erythematosus (SLE) using the ACR and/or SLICC criteria. A negative ANA was reported for 111 (36.9%) and an ANA that fluctuated was reported in 27 (33.3%). SLE criteria were met by 20 ANA negative patients (18.0%) and 12 patients with a fluctuating ANA (44.4%). Among 32 patients who had either a negative or fluctuating ANA and met criteria for SLE, at least one organ system other than skin was involved in 27 patients (84.4%), and at least two organ systems other than skin were involved in 13 patients (40.6%). As per these findings, patients with systemic disease do not always demonstrate an ANA. Researchers recommend considering these findings when devising an SLE classification criteria to be used for clinical trials.