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Results

Fifty-four children (mean age 11±4 years) with INS dependent on prednisone and calcineurin inhibitors for> 12 months were randomized. Three-month proteinuria was 70% lower in the RTX arm (95% confidence interval 35% to 86%) as compared with standard therapy arm (intention-to-treat); relapse rates were 18.5%(intervention) and 48.1%(standard arm)(P= 0.029). Probabilities of being drug-free at 3 months were 62.9% and 3.7%, respectively (P< 0.001); 50% of RTX cases were in stable remission without drugs after 9 months.

Conclusions

Rituximab and lower doses of prednisone and calcineurin inhibitors are noninferior to standard therapy in maintaining short-term remission in children with INS dependent on both drugs and allow their temporary withdrawal.