ABSTRACT
BACKGROUND: Reduced serum IgG level is associated with increased risk of infection. We investigated the circulating IgG level and its determining factors in active lupus nephritis patients treated with corticosteroids and mycophenolate mofetil (MMF). METHODS: This was a retrospective study on the longitudinal IgG profile in Class III/IV ± V lupus nephritis patients treated with prednisolone and MMF. RESULTS: 46 patients were included. At baseline, 34 (73.9%) patients (Group I) had normal or elevated IgG (1444.0 ± 600.5 mg/dL) while 12 (26.1%) (Group II) had IgG levels (567.8 ± 160.9 mg/dL) below the lower limit of normal. IgG levels at baseline, three, six and 12 months after treatment were 1215.4 ± 649.7 mg/dL, 843.9 ± 347.6 mg/dL, 914.5 ± 362.4 mg/dL and 1034.6 ± 452.5 mg/dL respectively. Treatment with prednisolone and MMF led to a significant drop in IgG after two weeks, reaching a nadir at eight weeks, followed by gradual normalization. Similar changes in IgG were observed in Group I patients but there was non-significant change in Group II within the first 24 weeks. Eighteen (39.1%) patients had low IgG by six months, and only one patient had IgG <300 mg/dL, at both three and six months. IgG level was negatively associated with proteinuria at six months (r = -0.711, p = 0.010). Five of 18 patients with low IgG had infections within the first year, while IgG levels below the lower limit of normal did not increase infection risk (relative risk 1.863; 95% confidence interval 0.466 to 6.818, p = 0.280). CONCLUSION: Reduced IgG occurred in 26% of active lupus nephritis patients and the IgG levels are significantly influenced by the severity of proteinuria. Treatment with prednisolone and MMF does not result in clinically important suppression of IgG.
Subject(s)
Adrenal Cortex Hormones/therapeutic use , Immunoglobulin G/blood , Immunosuppressive Agents/therapeutic use , Lupus Nephritis/blood , Lupus Nephritis/drug therapy , Mycophenolic Acid/analogs & derivatives , Prednisolone/therapeutic use , Adult , Female , Humans , Male , Mycophenolic Acid/therapeutic use , Retrospective StudiesABSTRACT
BACKGROUND: Mycophenolate has been shown to be effective in glomerular disease. However, the role of mycophenolate in the first-line treatment of adult-onset idiopathic minimal change disease (MCD) has not been systematically studied in a randomized fashion. AIM: To evaluate the therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for MCNS. DESIGN: A prospective, open-label, randomized clinical trial. METHODS: Twenty adult patients with biopsy proven MCD were recruited and randomly assigned to receive either enteric-coated Mycophenolate Sodium (EC-MPS) plus low-dose prednisolone (Group 1: Prednisolone 0.25 mg/kg/day, n = 10) or standard-dose prednisolone (Group 2: Prednisolone 1 mg/kg/day, n = 10). RESULTS: After 24 weeks of therapy, eight patients in Group 1 vs. seven of patients in Group 2 achieved complete remission (P = 0.606). Both groups showed a significant reduction of urine protein excretion (P < 0.05) and increased serum albumin (P < 0.001) vs. baseline levels. However, no significant between-group differences were demonstrated. The relapse rate was also similar in both groups. Both treatment regimens were well tolerated but there were more patient reported adverse effects in the standard-dose prednisolone group. CONCLUSION: EC-MPS plus low-dose prednisolone is non-inferior to standard-dose prednisolone therapy in inducing clinical remission and preventing relapse in adult-onset idiopathic MCD and is associated with better tolerability and less adverse effects. This trial is registered with the ClinicalTrials.gov number NCT01185197.