title: Renal outcome in patients with lupus nephritis using a steroid-free regimen of monthly intravenous cyclophosphamide: a prospective observational study.
abstract: OBJECTIVE
  Intravenous cyclophosphamide (IV CYC) in combination with high doses of corticosteroids is considered the "gold standard" of therapy for lupus nephritis (LN). However, the optimal dose of corticosteroids needed has not been defined. We evaluated the efficacy of a monotherapy with IV CYC in patients with a first episode of LN (duration ≤ 6 months).
  
  
  METHODS
  Forty patients with LN received IV CYC (12 pulses). Prednisone alone was administered and dose-adjusted to control extrarenal manifestations. Response after 24 months was defined as normalization of creatinine level, inactive urinary sediment, and proteinuria ≤ 0.2 g/day [complete response (CR)] or ≤ 0.5 g/day [partial response (PR)].
  
  
  RESULTS
  CR was achieved in 25 (62.5%) and PR in 8 (20%) patients. Mean starting dose of prednisone was 23.9 ± 23.8 mg/day. In a posthoc analysis, we separately analyzed patients initially treated with prednisone doses ≥ 20 mg/day (Group A, n = 19) or < 20 mg/day (Group B, n = 21). CR was achieved in 52.6% (Group A) versus 71.4% (Group B; p = 0.37); and PR in 26.3% versus 14.3%, respectively (p = 0.58). During longterm followup (10.4 ± 3.1 yrs), 37.8% experienced a renal flare. Thirty patients (81%) still have normal renal function. Renal outcome was irrespective of initial prednisone doses (p = 0.46, Pearson chi-square test of independence).
  
  
  CONCLUSIONS
  Our rates of CR and PR and longterm outcomes were comparable with rates after treatment with a combination of IV CYC with high doses of corticosteroids. These data warrant randomized controlled trials evaluating different doses of corticosteroids in LN.
authors.affiliation: Department of Endocrinology, Diabetology and Rheumatology and the Department of Nephrology, Heinrich-Heine University, Duesseldorf, Germany. rebecca.fischer@med.uni-duesseldorf.de
authors.forename: Rebecca
authors.initials: R
authors.lastname: Fischer-Betz
authors.forename: Gamal
authors.initials: G
authors.lastname: Chehab
authors.forename: Oliver
authors.initials: O
authors.lastname: Sander
authors.forename: Stefan
authors.initials: S
authors.lastname: Vordenbäumen
authors.forename: Adina
authors.initials: A
authors.lastname: Voiculescu
authors.forename: Ralph
authors.initials: R
authors.lastname: Brinks
authors.forename: Matthias
authors.initials: M
authors.lastname: Schneider
mesh_terms: D061605:Administration, Intravenous; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D003404:Creatinine / Q000378:metabolism; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D015994:Incidence; D007668:Kidney / Q000187:drug effects / Q000378:metabolism / Q000503:physiopathology; D008181:Lupus Nephritis / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D011241:Prednisone / Q000627:therapeutic use; D011446:Prospective Studies; D011507:Proteinuria / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D003520:Cyclophosphamide; D003404:Creatinine; D011241:Prednisone