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Safety and Efficacy of Alemtuzumab Induction in Highly Sensitized Pediatric Renal Transplant Recipients

Kim, Irene K. MD; Choi, Jua PharmD; Vo, Ashley A. PharmD; Kang, Alexis BS; Patel, Mitasha BS; Toyoda, Mieko PhD; Mirocha, James MS; Kamil, Elaine S. MD; Cohen, J. Louis MD; Louie, Sabrina MPH; Galera, Odette CLS; Jordan, Stanley C. MD; Puliyanda, Dechu P. MD

doi: 10.1097/TP.0000000000001416
Original Clinical Science—General

Background Studies show that alemtuzumab, a potent lymphocyte-depleting agent, is well tolerated in pediatric renal transplantation. We report on the use of alemtuzumab induction in highly HLA sensitized (HS) pediatric kidney transplant patients.

Methods Fifty pediatric renal transplants were performed from 1/2009-12/2014. 15 HS patients received IVIG (2 g/kg ×2 doses)/rituximab (375 mg/m2 ×1) for desensitization with alemtuzumab induction (15-30 mg, 1 dose, subcutaneous), whereas 35 nonsensitized patients received anti–IL-2R. Graft survival and infections were compared between 2 groups.

Results All HS patients had received a prior transplant and were older with lower risk for viral infections due to serostatus. Patient survival was 100%, and graft outcomes were similar with mean 1-year creatinine of 1.03 ± 0.45 versus 0.99 ± 0.6 (P = 0.48). Although a higher incidence of acute cellular rejection was seen in HS patients receiving alemtuzumab (P = 0.001), there was a nonsignificant difference in antibody-mediated rejection. White blood cell and absolute lymphocyte count were significantly lower in alemtuzumab group at 30 days (P < 0.0001) and at 1 year (P = 0.026 and P = 0.001), respectively. There was no significant difference in bacterial, viral, or fungal infections after transplant.

Conclusions Alemtuzumab induction with desensitization led to nearly equivalent graft survival and functional outcomes in HS pediatric patients as nonsensitized patients receiving anti–IL-2R induction. With this small sample size, we observed significant reduction of white blood cell and absolute lymphocyte count up to 1 year posttransplant. The risk of infection was comparable between the 2 groups; however, patients who received alemtuzumab were older and at lower risk of viral infection due to serostatus.

This single-center retrospective study suggests that desensitization followed by alemtuzumab induction is effective and safe in highly HLA-sensitized pediatric kidney transplant recipients compared to anti-IL-2R induction in nonsensitized patients. Interpretation of the findings is limited by differences in baseline demographic characteristics.

1 Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA.

2 Biostatistics Core, Cedars-Sinai Medical Center, Los Angeles, CA.

Received 22 February 2016. Revision received 20 May 2016.

Accepted 28 May 2016.

The authors declare no funding or conflicts of interest.

I.K.K. has contributed to the conception and design of the study, data interpretation, drafting, and revising the article. J.C. has contributed to the conception of the study, data analysis, and revising the article. A.V. has contributed to the conception of the study, data analysis, and revising the article. A.K. has contributed to the conception of the study, data collection, and revising the article. M.P. has contributed to the conception of the study, data collection, and revising the article. M.T. has contributed to the conception of the study, data analysis, and revising the article. J.M. has contributed to the conception of the study, statistical analysis, and revising the article. E.S.K. has contributed to the conception of the study, data analysis, and revising the article. J.L.C. has contributed to the conception of the study, data analysis, and revising the article. S.L. has contributed to the conception of the study, data collection, and revising the article. O.G. has contributed to the conception of the study, data analysis, and revising the article. S.C.J. has contributed to the conception and design of the study, data analysis, and revising the article. D.P.P. has contributed to the conception and design of the study, data analysis, and revising the article.

Correspondence: Irene K. Kim, MD, Comprehensive Transplant Center, Cedars-Sinai Medical Center, 8900 Beverly Blvd., Los Angeles, CA 90048. (Irene.kim@cshs.org).

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