A Prospective, Pilot Study of Early Corticosteroid Cessation in High-Immunologic-Risk Patients: The Cincinnati Experience

• Published in: Transplantation proceedings Vol. 37; no. 2; pp. 802 - 803
• Main Authors: Alloway, R.R., Hanaway, M.J., Trofe, J., Boardman, R., Rogers, C.C., Buell, J.F., Munda, R., Alexander, J.W., Thomas, M.J., Roy-Chaudhury, P., Cardi, M., Woodle, E.S.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-03-2005
• Subjects: Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - adverse effects; Adult; Aged; Antilymphocyte Serum - therapeutic use; Drug Administration Schedule; Drug Therapy, Combination; Female; Graft Rejection - prevention & control; Humans; Immunosuppressive Agents - therapeutic use; Kidney Transplantation - immunology; Male; Middle Aged; Patient Selection; Pilot Projects; Prospective Studies
• ISSN: 0041-1345; 1873-2623
• DOI: 10.1016/j.transproceed.2004.12.129

The first prospective trial of steroid withdrawal dedicated to high-immunologic-risk patients is reported herein.
Twenty-five patients were enrolled prospectively in an IRB-approved HIPAA-compliant protocol. Immunosuppression included corticosteroid withdrawal (CSWD) at 7 days, tacrolimus (target trough level 4 to 8 ng/mL), sirolimus (target trough level 8 to 12 ng/mL), and Mycophenolate Mofetil (2 g/d). Induction with daclizumab (2 mg/kg) on posttransplant days (PTD) 0 and 14 was administered to the first 10 patients. The protocol for the next 15 patients was modified because of high acute rejection rates to include received T-cell–depleting antibody induction therapy with thymoglobulin (1.5 mg/kg) on PTDs 0 and 2 followed by daclizumab on Postoperative day (POD) 14. Recipient inclusion criteria included: (1) repeat transplant recipients; or (2) patients with a peak PRA ≥25%. All rejection episodes were diagnosed by biopsy and graded using Banff '97 criteria.
Twenty-five patients were enrolled and median follow-up was 402 days. Forty percent of recipients were black, 68% of patients were repeat transplant recipients, 68% received deceased donor kidneys, and 36% had a peak flow PRA >25%. Overall acute rejection, graft survival, and patient survival rates of 40%, 88%, and 96%, respectively, were observed for the duration of the study. Acute rejection occurred in 6 of 10 patients (60%) with daclizumab induction; however, acute rejection rates fell to 27% when thymoglobulin was introduced (
P = .1).
This study supports our previous observations in a multivariate analysis of early CSWD patients, wherein polyclonal antibody induction therapy reduced acute rejection. High-immunologic-risk patients may be able to undergo early CSWD with acceptable rates of acute rejection.