[Efficacy analysis of maintenance therapy with levamisole compared to mycophenolate mofetil after rituximab treatment in children].

Objective

To investigate the efficacy and safety of levamisole(LEV) versus mycophenolate mofetil(MMF) as maintenance therapy following rituximab treatment in children with steroid-sensitive nephrotic syndrome(SSNS).

Methods

This was a retrospective cohort study. Clinical data were collected form 42 children with SSNS treated with RTX at the Department of Nephrology, Rheumatology and Immunology at the Children's Hospital Affiliated to Zhengzhou University between March 2023 and May 2024. Based on the sequential maintenance medication administered after B-cell reconstitution, the patients were assigned to 2 groups: the LEV group and the MMF group. The number of disease relapses, cumulative dosage of glucocorticoid and cumulative hospitalization times were compared between the 2 groups before and after treatment. The 2 groups were compared regarding the number of recurrences within 1 year after RTX treatment, time to the first recurrence, annual recurrence rate, cumulative glucocorticoid dose, cumulative number of hospitalizations, as well as the occurrence of adverse reactions. Intergroup comparisons were made using the Mann-Whitney U test, χ2 test or Fisher exact test, as appropriate. Recurrence-free survival curves were plotted using the Kaplan-Meier method.

Results

A total of 42 pediatric patients were enrolled, comprising 37 males and 5 females. The age of disease onset was 4.3 (3.0,6.3) years. There were 21 patients in the LEV group and 21 in the MMF group. Within 1 year after RTX treatment, the recurrence times decreased significantly in both the LEV group and the MMF group (0.0(0.0, 1.0) vs. 1.0(1.0, 2.0), 0.0(0.0, 0.0) vs. 1.0(1.0, 2.0) times/year, Z=4.24, 4.88, both P<0.001). Furthermore, the recurrence times after treatment was significantly higher in the LEV group than in the MMF group (P<0.05). Patients in the LEV group exhibited a significantly lower recurrence-free survival rate and a shorter recurrence-free survival time compared to those in the MMF group, along with a higher annual recurrence rate (all P<0.05). Furthermore, both the cumulative glucocorticoid dose and the cumulative number of hospitalizations decreased significantly after treatment in each group compared to baseline (all P<0.05). The 2 groups showed no significant difference in the incidence of adverse reactions (P>0.05).

Conclusion

Sequential therapy with MMF after RTX treatment represents a more favorable option than LEV for maintaining disease remission in children with SSNS.