A double-blind, randomized controlled trial of hydroxychloroquine for cognitive dysfunction and antibody biomarkers in systemic lupus erythematosus patients

Abstract

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that leads to persistent inflammation, resulting in organ tissue damage. Cognitive dysfunction is one of the symptoms often found in NPSLE, and hydroxychloroquine is recommended for all levels of SLE from mild to severe. However, studies on the efficacy of hydroxychloroquine for cognitive dysfunction have not been studied. Therefore, this study aimed to evaluate the effect of hydroxychloroquine administration on antibody levels and cognitive function in lupus patients with cognitive dysfunction. Methods: A Randomized Controlled Trial (RCT) was conducted in patients with SLE who experienced cognitive dysfunction. The treatment group consisted of 20 subjects subjected to standard therapy along with a daily dosage of hydroxychloroquine (200 mg/day) for 8 weeks. Furthermore, the control group comprised 20 subjects who only received standard therapy. The primary outcome of this trial focused on the evaluation of MoCA-INA and sub-MoCA-INA scores, while the secondary outcome included the measurement of anti-NMDA, anti-β2-glycoprotein-1, anticardiolipin IgM and IgG antibodies, as well as lupus anticoagulant levels. Data analysis for unpaired variables used the independent t-test or the Mann-Whitney test. Results: There was a relationship between giving hydroxychloroquine administration to increasing the sub-MOCA-INA attention score (p<0.05). However, there was no relationship between giving hydroxychloroquine to increasing MoCAINA scores and decreasing biomarker levels of anti-NMDA, anti-β2-glycoprotein-1, IgM-IgG anticardiolipin, and lupus anticoagulant (p>0.05). Conclusion: Administration of hydroxychloroquine only affected attentional MoCA-INA sub-scores but did not affect other MoCA-INA sub-scores, overall MoCA-INA scores, and antibody levels.