Rituximab and intravenous immune globulin for desensitization during renal transplantation. Export

@article{citeulike:3021384, abstract = {BACKGROUND: Few options for transplantation currently exist for patients highly sensitized to HLA. This exploratory, open-label, phase 1-2, single-center study examined whether intravenous immune globulin plus rituximab could reduce anti-HLA antibody levels and improve transplantation rates. METHODS: Between September 2005 and May 2007, a total of 20 highly sensitized patients (with a mean [+/-SD] T-cell panel-reactive antibody level, determined by use of the complement-dependent cytotoxicity assay, of 77+/-19\% or with donor-specific antibodies) were enrolled and received treatment with intravenous immune globulin and rituximab. We recorded rates of transplantation, panel-reactive antibody levels, cross-matching results at the time of transplantation, survival of patients and grafts, acute rejection episodes, serum creatinine values, adverse events and serious adverse events, and immunologic factors. RESULTS: The mean panel-reactive antibody level was 44+/-30\% after the second infusion of intravenous immune globulin (P<0.001 for the comparison with the pretreatment level). At study entry, the mean time on dialysis among recipients of a transplant from a deceased donor was 144+/-89 months (range, 60 to 324). However, the time to transplantation after desensitization was 5+/-6 months (range, 2 to 18). Sixteen of the 20 patients (80\%) received a transplant. At 12 months, the mean serum creatinine level was 1.5+/-1.1 mg per deciliter (133+/-97 micromol per liter), and the mean survival rates of patients and grafts were 100\% and 94\%, respectively. There were no infusion-related adverse events or serious adverse events during the study. Long-term monitoring for infectious complications and neurologic problems revealed no unanticipated events. CONCLUSIONS: These findings suggest that the combination of intravenous immune globulin and rituximab may prove effective as a desensitization regimen for patients awaiting a transplant from either a living donor or a deceased donor. Larger and longer trials are needed to evaluate the clinical efficacy and safety of this approach. (ClinicalTrials.gov number, NCT00642655.)}, address = {Comprehensive Transplant Center, Transplant Immunology Laboratory, Cedars-Sinai Medical Center, Los Angeles 90048, USA. ashley.vo@cshs.org}, author = {Vo, A. A. and Lukovsky, M. and Toyoda, M. and Wang, J. and Reinsmoen, N. L. and Lai, C. H. and Peng, A. and Villicana, R. and Jordan, S. C.}, citeulike-article-id = {3021384}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa0707894}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/18635429}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=18635429}, day = {17}, doi = {10.1056/NEJMoa0707894}, issn = {1533-4406}, journal = {The New England journal of medicine}, keywords = {ivig, rituximab}, month = {July}, number = {3}, pages = {242--251}, posted-at = {2008-07-20 02:23:35}, priority = {2}, title = {Rituximab and intravenous immune globulin for desensitization during renal transplantation.}, url = {http://dx.doi.org/10.1056/NEJMoa0707894}, volume = {359}, year = {2008} }

TY - JOUR ID - citeulike:3021384 L3 - citeulike-article-id:3021384 N2 - BACKGROUND: Few options for transplantation currently exist for patients highly sensitized to HLA. This exploratory, open-label, phase 1-2, single-center study examined whether intravenous immune globulin plus rituximab could reduce anti-HLA antibody levels and improve transplantation rates. METHODS: Between September 2005 and May 2007, a total of 20 highly sensitized patients (with a mean [+/-SD] T-cell panel-reactive antibody level, determined by use of the complement-dependent cytotoxicity assay, of 77+/-19% or with donor-specific antibodies) were enrolled and received treatment with intravenous immune globulin and rituximab. We recorded rates of transplantation, panel-reactive antibody levels, cross-matching results at the time of transplantation, survival of patients and grafts, acute rejection episodes, serum creatinine values, adverse events and serious adverse events, and immunologic factors. RESULTS: The mean panel-reactive antibody level was 44+/-30% after the second infusion of intravenous immune globulin (P<0.001 for the comparison with the pretreatment level). At study entry, the mean time on dialysis among recipients of a transplant from a deceased donor was 144+/-89 months (range, 60 to 324). However, the time to transplantation after desensitization was 5+/-6 months (range, 2 to 18). Sixteen of the 20 patients (80%) received a transplant. At 12 months, the mean serum creatinine level was 1.5+/-1.1 mg per deciliter (133+/-97 micromol per liter), and the mean survival rates of patients and grafts were 100% and 94%, respectively. There were no infusion-related adverse events or serious adverse events during the study. Long-term monitoring for infectious complications and neurologic problems revealed no unanticipated events. CONCLUSIONS: These findings suggest that the combination of intravenous immune globulin and rituximab may prove effective as a desensitization regimen for patients awaiting a transplant from either a living donor or a deceased donor. Larger and longer trials are needed to evaluate the clinical efficacy and safety of this approach. (ClinicalTrials.gov number, NCT00642655.) IS - 3 JF - The New England journal of medicine SN - 1533-4406 AD - Comprehensive Transplant Center, Transplant Immunology Laboratory, Cedars-Sinai Medical Center, Los Angeles 90048, USA. ashley.vo@cshs.org EP - 251 TI - Rituximab and intravenous immune globulin for desensitization during renal transplantation. VL - 359 SP - 242 KW - ivig KW - rituximab AU - Vo, AA AU - Lukovsky, M AU - Toyoda, M AU - Wang, J AU - Reinsmoen, NL AU - Lai, CH AU - Peng, A AU - Villicana, R AU - Jordan, SC PY - 2008/07/17/ UR - http://dx.doi.org/10.1056/NEJMoa0707894 ER -