Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis

Pediatr Nephrol. 2017 Jun;32(6):1013-1021. doi: 10.1007/s00467-017-3583-x. Epub 2017 Feb 12.


Background: Childhood-onset lupus nephritis (LN) is one of the most severe manifestations of systemic lupus erythematosus (SLE). Despite treatment-related toxicities, cyclophosphamide (CYC) and glucocorticoid-based treatment protocols are still considered standard therapy in managing this multisystem disorder. An effective and safe alternative induction regimen is needed.

Methods: Forty-four pediatric patients with active LN aged 3.5-13.8 (median 8.4) years, of whom 32 entered the study at diagnosis of SLE, were followed over 36 months. Induction therapy consisted of methylprednisolone pulses followed by either rituximab (RTX) (n = 17), mycophenolate mofetil (MMF) (n = 12) or pulse-CYC (n = 15), with tapering dose of prednisolone orally. MMF was added as maintenance immunosuppressant (800 mg/m2 daily) in all children from the third month onward.

Results: Flare-free survival was significantly higher at 36 months with RTX compared with MMF and CYC (100% for RTX vs. 83% for MMF. and 53% for CYC, p = 0·006). Twelve patients (76.5%) achieved complete remission with RTX compared with five (41.7%) and seven (46.7%) with MMF and CYC, respectively, at last follow-up. Requirement of mean daily dosage of prednisone was significantly lower in RTX group [p = 0.005 (RTX vs MMF); 0.0001 (RTX vs CYC) at 36 months] compared with other groups after the 3-month follow-up. In comparison with few minor adverse events in the other two cohorts, several serious adverse events occurred in the CYC group.

Conclusions: Efficacy and medium-term safety of RTX induction followed by MMF maintenance therapy in inducing and maintaining remission among children with LN were evident in this study.

Keywords: Cyclophosphamide; Lupus nephritis; Mycophenolate mofetil; Pediatric SLE; Rituximab.

Publication types

  • Comparative Study

MeSH terms

  • Child
  • Child, Preschool
  • Clinical Protocols
  • Cyclophosphamide / therapeutic use
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Lupus Nephritis / drug therapy*
  • Lupus Nephritis / mortality*
  • Male
  • Methylprednisolone / therapeutic use
  • Mycophenolic Acid / therapeutic use
  • Prednisone / therapeutic use
  • Remission Induction / methods
  • Retrospective Studies
  • Rituximab / therapeutic use*
  • Survival Analysis
  • Treatment Outcome


  • Immunosuppressive Agents
  • Rituximab
  • Cyclophosphamide
  • Mycophenolic Acid
  • Prednisone
  • Methylprednisolone