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Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial
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Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial
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Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial
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Journal Article
Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial
2012
Overview
The safety and efficacy of mycophenolate mofetil (MMF) were evaluated in adolescent patients with systemic lupus erythematosus and active or active/chronic class III–V lupus nephritis. During the 24-week induction phase, patients were randomized to oral MMF (target dose 3.0 g/day) or intravenous cyclophosphamide (IVC) (0.5–1.0 g/m2/month), plus prednisone. Response was defined as a decrease in 24-hour urine protein:creatinine ratio (P:Cr) to <3 in patients with baseline nephrotic range proteinuria, or by ≥50% if subnephrotic baseline proteinuria, and stabilization (±25%) or improvement in serum creatinine. In the 36-month maintenance phase, induction therapy responders were randomized 1:1 to MMF (1.0 g twice daily) or oral azathioprine (AZA) (2 mg/kg/day), plus prednisone. In the induction phase, 10 patients received MMF and 14 received IVC; 15 (62.5%) achieved treatment response (MMF, 7 (70%); IVC, 8/15 (57.1%); p = 0.53, odds ratio (95% confidence interval) 2.0 (0.2, 15.5)). There was a non-statistically significant difference in maintenance of response to MMF (7/8; 87.5%) versus AZA (3/8; 37.5%). Seven patients withdrew (MMF, 2; AZA, 5). During both phases, rates of serious adverse events were similar in both arms. During both phases treatment response with MMF was as effective as the comparator.
Publisher
SAGE Publications,Sage Publications Ltd
Subject
/ Asia
/ Azathioprine - therapeutic use
/ Cyclophosphamide - therapeutic use
/ Europe
/ Female
/ Humans
/ Immunosuppressive Agents - administration & dosage
/ Immunosuppressive Agents - adverse effects
/ Immunosuppressive Agents - therapeutic use
/ Lupus
/ Lupus Nephritis - complications
/ Lupus Nephritis - drug therapy
/ Male
/ Mycophenolic Acid - administration & dosage
/ Mycophenolic Acid - adverse effects
/ Mycophenolic Acid - analogs & derivatives
/ Mycophenolic Acid - therapeutic use
/ Prednisone - therapeutic use
/ Steroids
/ Systemic lupus erythematosus
/ Urine
