Clinical Observations On The Treatment Of Systemic Lupus Erythematosus With Iguratimod Versus Hydroxychloroquine

Objective of the study:To observe the efficacy and safety of iguratimod in the treatment of systemic lupus erythematosus and to compare it with hydroxychloroquine.Methods:According to the inclusion and exclusion criteria,27patients diagnosed with SLE from December 2020 to August 2021 at the Department of Rheumatology and Nephrology,Central South University Xiangya Third Hospital were selected,and 3 patients were withdrawn.The iguratimod group was given 25mg of iguratimod orally twice daily and the Hydroxychloroquine group was given 0.1g of Hydroxychloroquine orally twice daily;the doses of other immunosuppressive agents and their use were to be maintained and the dose of glucocorticoids adjusted as appropriate during the study.Patients were followed up at week 0,week 8,week 16 and week 24 of the study,and basic information,SLEDAI-2K,BILAG-2004,PGA,hormone dosage and relevant laboratory parameters were recorded.Results:（1）The main observation of this study was the SRI₄ response rate between the two groups after 24 weeks.The SRI₄ response rate at week24 was 45.45%（n=5）and 46.15%（n=6）in the iguratimod and hydroxychloroquine groups respectively,with a difference of 0.7%（95%CI-32.8-34.2%）between the two groups,suggesting that iguratimod has non-inferior efficacy to hydroxychloroquine.（2）Comparing the changes in each secondary indicator from baseline values before and after 24 weeks of treatment in both groups,where the levels of SLEDAI-2K scores decreased from baseline values in both groups after 24 weeks of treatment,the difference before and after treatment in the Iguratimod group was not statistically significant,and the level of change in the hydroxychloroquine group was statistically significant（P=0.003<0.05）,the difference in SLEDAI-2K scores after 24 weeks of treatment in both groups from The comparison of the difference in baseline values was statistically significant（P=0.002<0.05）.After 24 weeks of treatment,there was a statistically significant change in C4 levels in the hydroxychloroquine group compared to baseline values（P=0.035<0.05）.Regarding other laboratory parameters including C3,urine protein,globulin,anti-ds DNA antibody and anti-ss DNA antibody,the difference between the two groups after 24 weeks of treatment compared to baseline values was not statistically significant.During treatment,there was an overall decreasing trend in SLEDAI-2K in both groups and a statistically significant trend over time（p=0.002<0.05）,while C4 levels in both groups showed an increasing trend over time during treatment.（3）Comparing the changes in inflammatory indexes and glucocorticoid dosage before and after treatment in the two groups,the levels of HSCRP and ESR in the iguratimod group decreased after 24weeks of treatment compared with the baseline values,and the level of decrease in ESR compared with the baseline value was statistically significant（P=0.011<0.05）,while the level of change in HSCRP was not statistically significant,in the hydroxychloroquine group,the levels of HSCRP and ESR decreased after treatment compared with the baseline values.In the hydroxychloroquine group,the levels of HSCRP and ESR decreased after treatment compared with the baseline values,which were statistically significant（P=0.024<0.05,P=0.011<0.05）,and the difference in inflammatory indexes between the two groups after 24 weeks of treatment compared with the baseline values was not statistically significant.After 24 weeks of treatment,glucocorticoid dosage was significantly reduced in both groups,and the level of change from baseline values was statistically significant（P=0.026<0.05,P=0.004<0.05）,and the difference between the two groups in terms of hormone dosage compared with baseline values after 24 weeks of treatment was statistically significant（P=0.036<0.05）.（4）After 24 weeks of treatment,the level of lymphocyte count in the iguratimod group showed a decreasing trend,and both T and B lymphocyte counts decreased significantly compared to the baseline value,with no statistically significant difference in lymphocyte count and T lymphocyte count before and after treatment,and a statistically significant change in B lymphocyte count before and after treatment（P=0.029<0.05）.In the hydroxychloroquine group,the lymphocyte count and T and B lymphocyte counts showed an increasing trend before and after treatment,the difference was not statistically significant.After 24weeks of treatment,there was a statistically significant difference between the iguratimod group and the hydroxychloroquine group in the B cell count level（P=0.023<0.05）.During the course of treatment,the levels of CD4,CD8 cells and NK cells in the iguratimod group tended to decrease,while the levels of CD4,CD8 cells and NK cells in the hydroxychloroquine group tended to increase,but the difference from baseline values and the difference between the two groups were not statistically significant.Conclusion:The combination of iguratimod with hormones and/or immunosuppressants improves the disease activity of patients with SLE,assists in the smooth reduction of hormones,is not inferior to hydroxychloroquine.