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Abstract: TH-OR120

Long-Term Efficacy of Rituximab and Mycophenolate Mofetil (MMF) Maintenance Therapy in Children with Steroid-Dependent Nephrotic Syndrome: RITURNS Trial Follow-Up

Session Information

Category: Pediatric Nephrology

  • 1700 Pediatric Nephrology

Authors

  • Schaefer, Franz S., University of Heidelberg, Heidelberg, BW, Germany
  • Basu, Biswanath, NRS Medical College, Kolkata, India
Background

In the RITURNS study we demonstrated superior efficacy of Rituximab over Tacrolimus in children with steroid dependent nephrotic syndrome (SDNS), with 88 vs. 69 % relapse-free survival during a 12-month observation period (Basu et al. JAMA Pediatr 2018). Here we present the long-term outcomes of the patients in the Rituximab arm.

Methods

59 of the 60 patients who had received a course of Rituximab (two infusions @375mg/m2) in the RITURNS Study were available during a 2-year follow-up period after the end of the RITURNS study. Relapsing patients received a second course of Rituximab, either with (n=44) or without MMF co-treatment (n=15).

Results

During the extended follow-up, all patients developed relapses, with a median time to first relapse of 63 weeks for the entire cohort (Fig.1). Those patients who received co-treatment with MMF after the second course of Rituximab showed longer remission than those who received Rituximab alone (80% relapse-free survival 84 vs. 30 weeks) (Fig.2), whereas the total relapse rate (1.34 ± 0.75 vs. 1.47 ± 0.64) and cumulative prednisolone exposure (41.9 ± 35.0 vs. 45.5 ± 28.0 mg/kg) did not differ significantly. Both treatment protocols were equally well tolerated.

Conclusion

Recurrence of nephrotic syndrome occurred in all SDNS patients within 6 to 24 months following the first course of Rituximab. Co-treatment with MMF after Rituximab re-treatment substantially extended the duration of remission, with 75% of patients remaining relapse-free two years after the second Rituximab course.

Funding

  • Government Support - Non-U.S.