Effectiveness?Safety And Possible Influencing Factors Of Low-dose Rituximab Therapy In Neuromyelitis Optica Spectrum Disorders

Objective:To propose a new scheme of low-dose rituximab in neu romyelitis optica spectrum disorders(NMOSD),and to evaluate the effi cacy,safety and discusse its influencing factors.Methods:A total of 48 patients with NMOSD in remission were prospectivel y included in the study.45 patients were followed up successfully and were given sequential treatment with low-dose RTX(100mg,twice week ly for 4 times),The level of CD20~+B cells,blood routine,liver functio n,nuclear magnetic resonance and visual function of the focus were mo nitored before and after treatment.The follow-up period is at least 6 m onths,The following contents were evaluated at 0,6 and 12 months.Co mparing extended disability scale(EDSS)score,and anxiety(GAD-7),depression(PHQ-9),fatigue(MFIS);At the same time recor ding recurrence event and recurrence time and comparing the annual rec urrence rate(ARR);Adverse events were recorded during follow-up.Results:1.In 48 patients with NMOSD,male:female was 6:42,wit h n average age of 34.763±13.437 years.3 patients withdrew from the group at the beginning of treatment because of side effects.45 patients were followed up successfully,including 12 cases in primary group an d 33 cases in recurrent group.The median viewing time was 1.0(0.8)years.EDSS score decreased from 4.5(3.25)to 2.5(2.50)(P<0.001),and the score of 5 items decreased after treatment(P<0.01);2.Th e scores of ADL,MFIS,GAD-7 and PHQ-9 decreased after treatment(P<0.05);3.The EDSS scores of 31 patients were significantly lower a t 6 or 12 months before and after treatment,and were significantly low er at 12 months than 6 months after treatment(P<0.001);4.There was a significant difference in the difference of EDSS score between the pri mary group and the recurrent group before and after treatment(P<0.01);5.There was no significant difference in the frequency of recurrence be tween the primary group and the recurrent group after treatment(P>0.05);6.The ARR of 33 patients in the recurrent group decreased from1.71(3.53)to 0(0),and the difference was statistically significant;7.Acute paroxysmal symptoms before application of RTX had medium positive correlation with the improvement of EDSS score(P<0.05,r=0.509),the improvement was more obvious in patients with myelitis than in patients with optic neuritis(P<0.01);course of disease and the num ber of attacks had a positive linear correlation with the EDSS score bef ore treatment,and a negative linear correlation with the EDSS differenc e(P<0.001,r=-0.581 and P<0.01,r=-0.501);8.A total of 33 adverse events were observed in 48 patients,the incidence was in the following order:infection,infusion reaction,anemia,sleep disorder,alopecia,leuk openia,extrapyramidal symptoms.Conclusions:1.The degree of disability was improved in patients with NMOSD treated with low-dose rituximab,In the five functional scores of vision,brainstem,pyramidal system,bladder and movement showed improvemen t;2.Self-care ability,fatigue,anxiety and depression are better than b efore;3.After treatment,the degree of functional disability of patients wa s improved at 6 and 12 months,and further improved at 12 months co mpared with 6 months.4.The degree of functional disability in the primary group was sign ificantly improved compared with that in the recurrent group5.The annual recurrence rate(ARR)of patients treated with RT X was lower than that before treatment;6.Acute paroxysmal symptoms before application of RTX had medi um positive correlation with the improvement of EDSS score,the impro vement was greater in patients with myelitis;Course of disease and the number of attacks were positively correlated with the degree of cumula tive functional disability before treatment,and negatively correlated with the change of the degree of disability after treatment.;7.Most of the adverse events were infection,but no patient receive d hospitalization,Only 5 cases of infusion reaction were observed due t o prophylactic medication in advance,and the treatment was terminated in 2 cases,Another patient stopped treatment due to rare extrapyramidal symptoms.Therefore,patients with RTX are still advised to pay close attention to the occurrence of their adverse events.