SUMMARYSystemic lupus erythematosus (SLE) is a chronic systemic autoimmune inflammatory disease and early diagnosis is of clinical and therapeutic importance. Melatonin is an endogenous endolamine hormone that plays an important role in the immune system due to its anti-inflammatory action. This study was designed to assess serum melatonin levels in SLE patients and to evaluate the possible correlation between serum melatonin and patients' baseline characteristics. A case-control study was performed on 50 SLE patients (48 females and 2 males), diagnosed according to the revised 1997 ACR Criteria, and 25 healthy controls (24 females and 1 male), matched by age and sex. Daily serum melatonin levels were investigated in all participants using human melatonin enzyme linked immunosorbent assay (ELISA) kit (MYBIOSOURCE (MBS), United States). Serum melatonin concentration was significantly lower in patients with SLE compared to healthy controls (19.17±6.86 pg/mL vs 23.26±6.71 pg/mL, p=0.017). Serum melatonin concentration ≤18.51 pg/mL was the optimum cut off value to differentiate between SLE patients and healthy controls with an accuracy of 69.3%, a sensitivity of 66%, and a specificity of 76%. The positive predictive value (PPV) at pretest 50% was 73.3% and PPV at pretest 90% was 96.1%; the negative predictive value (NPV) at 10% was 95.3%. Patients' characteristics were not significantly correlated with serum melatonin concentrations using multiple logistic regression analysis. Serum melatonin was a valid measure to differentiate between SLE patients and healthy controls with good accuracy, sensitivity and specificity and PPV and NPV. There was no significant correlation between serum melatonin concentrations and patients' baseline characteristics.Key words: Serum melatonin; systemic lupus erythematosus; autoimmune diseases. Reumatismo, 2017; 69 (4): 170-174 n INTRODUCTION S ystemic lupus erythematosus (SLE) is a multisystem autoimmune disease, characterized by a multitude of autoantibodies, complement activation and immune-complex deposition, which causes tissue and organ damage (1). The etiology and pathogenetic mechanisms of SLE are still unclear; no single cause for SLE has been identified (2). It is possible that the autoimmune disorder results from the combination of predisposing genetic factors and the disturbed status of stress response mechanisms, including the sympathetic nervous system and various hormones (3). Melatonin, produced by the pineal gland during the night, is the major secretory hormone and a key player in the neuroendocrine-immune pathway (4, 5). Melatonin can stimulate cytokine production, phagocytosis and natural killer cell activity. In vitro studies and animal experiments have provided evidence for a modulatory effect of melatonin in the immune response: melatonin receptors are expressed on the membrane of CD4 T cells, CD8 T cells, and B cells (6, 7), and melatonin treatment in mice showed increasing proliferation of T cells (8). In addition, it can antagonize the increasing levels of I...