Clinical trial on rituximab in the treatment of patients with neuromyelitis optica spectrum disorder
Objective To explore the changes in peripheral blood interleukin-23(IL-23)/IL-17A axis and microRNA-365-5p(miR-363-5p)in patients with neuromyelitis optica spectrum disorder(NMOSD)before and after treatment with rituximab.Methods NMOSD patients were divided into aquaporin-4 immunoglobulin G(AQP-4IgG)positive group and AQP-4IgG negative group based on the presence of AQP-4IgG antibodies.Both groups received continuous treatment with rituximab(PTX)for over one year.The therapeutic effect of the two groups was compared,and the annual recurrence times,ADL scores and peripheral blood expression levels of IL-23,IL-17A and miR-363-5p were compared before treatment and 12 months after treatment,and the occurrence of adverse drug reactions were recorded.Results AQP-4IgG positive group and AQP-4IgG negative group included 73 cases and 27 cases respectively.The clinical therapeutic effect of AQP-4IgG positive group and AQP-4IgG negative group was 84.93％and 70.37％,with no statistical significance(P＞0.05).Before treatment,the annual recurrence times of AQP-4IgG positive group and AQP-4IgG negative group were(1.36±0.32)and(1.33±0.41)times per year,the ADL scores were(62.36±5.76)and(63.27±5.38)points,IL-23 were(325.23±116.35)and(328.79±120.38)pg·mL-1,IL-17A were(68.46±12.38)and(69.61±13.41)pg·mL-1,miR-363-5p were 1.76±0.10 and 1.77±0.19,respectively.After 12 months of treatment,the annual recurrence times of AQP-4IgG positive group and AQP-4IgG negative group were(0.28±0.16)and(0.31±0.12)times per year,ADL scores were(85.10±10.36)and(81.26±11.34)points,IL-23 were(122.46±11.54)and(119.49±10.26)pg·mL-1,IL-17A were(43.16±6.29)and(40.27±8.75)pg·mL-1,miR-363-5p were 1.38±0.15 and 1.36±0.15,respectively.There were statistically significant differences in the above indexes between the two groups after treatment and before treatment(all P＜0.05),but no significant differences between the groups post-treatment(all P＞0.05).The incidence rates of adverse drug reactions were 13.69％in the AQP-4IgG positive group and 18.51％in the negative group,with no statistically significant difference(P＞0.05).Conclusion Rituximab is effective in treating NMOSD,reducing the number of annual relapses and promoting the recovery of patients'mobility.The mechanism may be related to regulating the IL-23/IL-17A axis and inhibiting the expression of miR-363-5p.
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