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Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients
Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J
Scientific reports. 2023;13(1):7682
Abstract
De novo donor-specific antibody (dnDSA) is associated with a higher risk of kidney graft failure. However, it is unknown whether preemptive treatment of subclinical dnDSA is beneficial. Here, we assessed the efficacy of high-dose intravenous immunoglobulin (IVIG) and rituximab combination therapy for subclinical dnDSA. An open-label randomized controlled clinical trial was conducted at two Korean institutions. Adult (aged ≥ 19 years) kidney transplant patients with subclinical class II dnDSA (mean fluorescence intensity ≥ 1000) were enrolled. Eligible participants were randomly assigned to receive rituximab or rituximab with IVIG at a 1:1 ratio. The primary endpoint was the change in dnDSA titer at 3 and 12 months after treatment. A total of 46 patients (24 for rituximab and 22 for rituximab with IVIG) were included in the analysis. The mean baseline estimated glomerular filtration rate was 66.7 ± 16.3 mL/min/1.73 m(2). The titer decline of immune-dominant dnDSA at 12 months in both the preemptive groups was significant. However, there was no difference between the two groups at 12 months. Either kidney allograft function or proteinuria did not differ between the two groups. No antibody-mediated rejection occurred in either group. Preemptive treatment with high-dose IVIG combined with rituximab did not show a better dnDSA reduction compared with rituximab alone.Trial registration: IVIG/Rituximab versus Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies (ClinicalTrials.gov Identifier: NCT04033276, first trial registration (26/07/2019).
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Efficacy and safety of intravenous immunoglobulin in patients with lupus nephritis: A systematic review of the literature
Cajamarca-Barón J, Buitrago-Bohórquez J, Orozco JEM, Segura O, Guavita-Navarro D, Gallego-Cardona L, Cubides H, Arredondo AM, Escobar A, Rojas-Villarraga A
Autoimmunity reviews. 2022;:103182
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Editor's Choice
Abstract
INTRODUCTION AND OBJECTIVE Intravenous immunoglobulin (IVIg) is an anti-inflammatory drug with an unclear role in the treatment of patients with lupus nephritis (LN). This systematic review evaluates the evidence for IVIg in the care of patients with LN. METHODOLOGY A systematic search was done in the PubMed, EMBASE, BVS and OVID databases - All EBM Reviews following the PRISMA methodology (registration in PROSPERO CRD42021236662). The variables were extracted: indications for use, dosage, partial or complete response, adverse reactions, initiation of renal replacement therapy, reduction of proteinuria, and mortality. The quality assessment was done with the "The Joanna Briggs Institute (JBI) Critical Appraisal tools for use in Systematic Reviews Checklist". In addition, synthesis reports were prepared through the Synthesis Without Meta-analysis - SWiM guide. RESULTS A total of 2328 articles were obtained (28 were considered for inclusion). When the studies were evaluated, IVIg therapy was found to be between 60% to 70% effective (except for patients with class V LN) with overall responses (complete + partial) even for patients who are refractory to first line treatment. Normalization (<0.5 g) of nephrotic proteinuria occurred in 24% of cases with infrequent adverse events and a mortality plus dialysis composite of 11.5% and 24.1% (most representative study). CONCLUSION In patients with LN refractory to conventional treatment or co-infection situations, the reported data seem to demonstrate effectiveness of IVIg therapy. There are few adverse reactions and caution is exercised when using it on patients with class V NL. However, given the lack of controlled studies with long-term follow-up, these data should be interpreted cautiously thus encouraging the development of high-quality RCTs.
PICO Summary
Population
Patients with lupus nephritis (LN), (28 studies).
Intervention
Systematic review to evaluate the efficacy and safety of intravenous immunoglobulin (IVIg).
Comparison
Various comparisons, including: indications for use, and dosage.
Outcome
When the studies were evaluated, IVIg therapy was found to be between 60% to 70% effective (except for patients with class V LN) with overall responses (complete + partial) even for patients who were refractory to first line treatment. Normalization (<0.5 g) of nephrotic proteinuria occurred in 24% of cases with infrequent adverse events and a mortality plus dialysis composite of 11.5% and 24.1% (most representative study).
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Evaluation of intravenous immunoglobulin as an agent to lower allosensitization and improve transplantation in highly sensitized adult patients with end-stage renal disease: report of the NIH IG02 trial
Jordan SC, Tyan D, Stablein D, McIntosh M, Rose S, Vo A, Toyoda M, Davis C, Shapiro R, Adey D, et al
Journal of the American Society of Nephrology. 2004;15((12):):3256-62.
Abstract
Reported are the reduction of anti-HLA antibody levels and improvement of transplant rates by intravenous immunoglobulin (IVIG) in a randomized, double-blind, placebo-controlled clinical trial. Between 1997 and 2000, a total of 101 adult patients with ESRD who were highly sensitized to HLA antigens (panel reactive antibody [PRA] > or =50% monthly for 3 mo) enrolled onto an NIH-sponsored trial (IG02). Patients received IVIG or placebo. Subjects received IVIG 2 g/kg monthly for 4 mo or an equivalent volume of placebo with additional infusions at 12 and 24 mo after entry if not transplanted. If transplanted, additional infusions were given monthly for 4 mo. Baseline PRA levels were similar in both groups. However, IVIG significantly reduced PRA levels in study subjects compared with placebo. Sixteen IVIG patients (35%) and eight placebo patients (17%) were transplanted. Rejection episodes occurred in 9 of 17 IVIG and 1 of 10 placebo subjects. Seven graft failures occurred (four IVIG, three placebo) among adherent patients with similar 2-yr graft survival rates (80% IVIG, 75% placebo). With a median follow-up of 2 yr after transplant, the viable transplants functioned normally with a mean +/- SEM serum creatinine of 1. 68 +/- 0. 28 for IVIG versus 1. 28 +/- 0. 13 mg/dl for placebo. Adverse events rates were similar in both groups. We conclude that IVIG is better than placebo in reducing anti-HLA antibody levels and improving transplantation rates in highly sensitized patients with ESRD. Transplant rates for highly sensitized patients with ESRD awaiting kidney transplants are improved with IVIG therapy.
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Preventive efficiency of IVIgG on nosocomial infection in the children with nephrotic syndrome Chinese
Dang X, Yi Z, Wang X, Wu X, Zhang X, He Q
Bulletin of Hunan Medical University. 1999;24((3):):290-2.
Abstract
In order to study the preventive efficiency of IVIgG on nosocomial infection(NI), 54 cases of the children with nephrotic syndrome(NS) were randomly divided into 2 groups, test group(n = 22) and control group(n = 32). Routine treatment was adopted to all cases. Besides the routine treatment, the test group was injected with IVIgG(100-300 mg.kg-1.d-1) for 2-3 days. The results showed that the NI rate of test group (13.6%) was significantly lower than that of the control(46.88%) (P < 0.05), and the hospital days of the test group(27.33 +/- 15.51) d was significantly shorter than that of the control(64.50 +/- 18.52) d (P < 0.05). These suggest that IVIgG, as one of the ways to prevent NI, can improve the immune state and effectively prevent the NI in the children with NS.
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Adjunctive therapy with intravenous human immunoglobulin G improves survival of patients with acute renal failure
Keane WF, Hirata-Dulas CA, Bullock ML, Ney AL, Guay DR, Kalil RS, Dinarello CA, Halstenson CE, Peterson PK
Journal of the American Society of Nephrology. 1991;2((4):):841-7.
Abstract
The objective of this prospective, randomized, double-blind, placebo-controlled clinical trial was to evaluate the efficacy of adjunctive therapy with iv human immunoglobulin G in reducing the morbidity and mortality associated with acute renal failure. Forty patients greater than or equal to 18 yr of age who were identified within 48 h of the onset of acute renal failure and who met the enrollment criteria were enrolled in the study. Thirty-five patients were considered evaluable. Patients were grouped according to the admitting service (medical or surgical/trauma) and were randomized to receive either immunoglobulin G (400 mg/kg body wt) or placebo (normal saline; 8 mL/kg body wt) at study entry and then weekly thereafter for a maximum of 4 doses. The groups were well balanced with respect to demographics, clinical presentation, and severity of illness (APACHE II scores). A significant reduction in mortality at 42 days after study entry was observed. Two of 17 (12%) patients in the immunoglobulin G-treated group compared with 8 of 18 (44%) patients in the placebo-treated group died (P = 0.025). No differences were observed in the frequency of major complications that occurred in association with acute renal failure. However, in patients who manifested infection, greater survival was observed in the immunoglobulin G treatment group. The results suggest that immunoglobulin G administered at the onset of acute renal failure reduced mortality possibly by decreasing the severity of infectious complications associated with the occurrence of of acute renal failure.(ABSTRACT TRUNCATED AT 250 WORDS)