title: Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
abstract: 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.
  
  
  
  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/m2daily) in all children from the third month onward.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Division of Pediatric Nephrology, Department of Pediatrics, NRS Medical College & Hospital, Kolkata, 700014, West Bengal, India. basuv3000@gmail.com.
authors.forename: Biswanath
authors.initials: B
authors.lastname: Basu
authors.affiliation: Department of Pediatrics, NRS Medical College & Hospital, Kolkata, India.
authors.forename: Birendranath
authors.initials: B
authors.lastname: Roy
authors.affiliation: Division of Pediatric Nephrology, Department of Pediatrics, NRS Medical College & Hospital, Kolkata, India.|Department of Pediatrics, Caritas Hospital, Kerala, India.
authors.forename: Binu George
authors.initials: BG
authors.lastname: Babu
mesh_terms: D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003520:Cyclophosphamide / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008181:Lupus Nephritis / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D009173:Mycophenolic Acid / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use; D012074:Remission Induction / Q000379:methods; D012189:Retrospective Studies; D000069283:Rituximab / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000069283:Rituximab; D003520:Cyclophosphamide; D009173:Mycophenolic Acid; D011241:Prednisone; D008775:Methylprednisolone
keywords: Cyclophosphamide; Lupus nephritis; Mycophenolate mofetil; Pediatric SLE; Rituximab