Association between the pharmacokinetics of rabbit anti-thymocyte globulin and acute graft-versus-host disease in patients who received haploidentical hematopoietic stem cell transplantation.
ATG
Concentration
GVHD
Haploidentical hematopoietic stem cell transplantation
Pharmacokinetics
Journal
International journal of hematology
ISSN: 1865-3774
Titre abrégé: Int J Hematol
Pays: Japan
ID NLM: 9111627
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
15
12
2021
accepted:
29
03
2022
revised:
28
03
2022
pubmed:
7
5
2022
medline:
28
7
2022
entrez:
6
5
2022
Statut:
ppublish
Résumé
Anti-thymocyte globulin (ATG) is an important prophylactic drug against acute graft-versus-host disease (aGVHD) after haploidentical hematopoietic stem cell transplantation (haplo-HSCT). This study analyzed the pharmacokinetics of rabbit ATG 2.5 mg/kg and its effect against aGVHD in 24 patients undergoing unmanipulated haplo-HSCT. All patients had hematological malignancies not in remission. The median absolute lymphocyte count (ALC) before rabbit ATG administration was 9.5/µL (range 0-41/µL). The grade ≥ II aGVHD group had a significantly lower median rabbit ATG concentration on days 0 (C
Identifiants
pubmed: 35522381
doi: 10.1007/s12185-022-03342-8
pii: 10.1007/s12185-022-03342-8
doi:
Substances chimiques
Antilymphocyte Serum
0
thymoglobulin
D7RD81HE4W
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
248-257Informations de copyright
© 2022. Japanese Society of Hematology.
Références
Beatty PG, Clift RA, Mickelson EM, Nisperos BB, Flournoy N, Martin PJ, et al. Marrow transplantation from related donors other than HLA-identical siblings. N Engl J Med. 1985;313:765–71.
doi: 10.1056/NEJM198509263131301
Anasetti C, Amos D, Beatty PG, Appelbaum FR, Bensinger W, Buckner CD, et al. Effect of HLA compatibility on engraftment of bone marrow transplants in patients with leukemia or lymphoma. N Engl J Med. 1989;320:197–204.
doi: 10.1056/NEJM198901263200401
Anasetti C, Beatty PG, Storb R, Martin PJ, Mori M, Sanders JE, et al. Effect of HLA incompatibility on graft-versus-host disease, relapse, and survival after marrow transplantation for patients with leukemia or lymphoma. Hum Immunol. 1990;29:79–91.
doi: 10.1016/0198-8859(90)90071-V
Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, et al. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005;23:3447–54.
doi: 10.1200/JCO.2005.09.117
O’Donnell PV, Luznik L, Jones RJ, Vogelsang GB, Leffell MS, Phelps M, et al. Nonmyeloablative bone marrow transplantation from partially HLA-mismatched related donors using posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2002;8:377–86.
doi: 10.1053/bbmt.2002.v8.pm12171484
Brunstein CG, Fuchs EJ, Carter SL, Karanes C, Costa LJ, Juan W, et al. Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts. Blood. 2011;118:282–8.
doi: 10.1182/blood-2011-03-344853
Hoegh-Petersen M, Amin MA, Liu Y, Ugarte-Torres A, Williamson TS, Podgorny PJ, et al. Anti-thymocyte globulins capable of binding to T and B cells reduce graft-vs-host disease without increasing relapse. Bone Marrow Transplant. 2013;48:105–14.
doi: 10.1038/bmt.2012.99
Mohty M. Mechanisms of action of antithymocyte globulin: T-cell depletion and beyond. Leukemia. 2007;21:1387–94.
doi: 10.1038/sj.leu.2404683
Lu DP, Dong L, Wu T, Huang XJ, Zhang MJ, Han W, et al. Conditioning including antithymocyte globulin followed by unmanipulated HLA-mismatched/haploidentical blood and marrow transplantation can achieve comparable outcomes with HLA-identical sibling transplantation. Blood. 2006;107:3065–73.
doi: 10.1182/blood-2005-05-2146
Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, et al. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011;118:2609–17.
doi: 10.1182/blood-2011-02-339838
Ogawa H, Ikegame K, Yoshihara S, Kawakami M, Fujioka T, Masuda T, et al. Unmanipulated HLA 2–3 antigen-mismatched (haploidentical) stem cell transplantation using nonmyeloablative conditioning. Biol Blood Marrow Transplant. 2006;12:1073–84.
doi: 10.1016/j.bbmt.2006.06.007
Ogawa H, Ikegame K, Kaida K, Yoshihara S, Fujioka T, Taniguchi Y, et al. Unmanipulated HLA 2–3 antigen-mismatched (haploidentical) bone marrow transplantation using only pharmacological GVHD prophylaxis. Exp Hematol. 2008;36:1–8.
doi: 10.1016/j.exphem.2007.08.013
Tamaki H, Ikegame K, Kawakami M, Fujioka T, Tsuboi A, Oji Y, et al. Successful engraftment of HLA-haploidentical related transplants using nonmyeloablative conditioning with fludarabine, busulfan and anti-T-lymphocyte globulin. Leukemia. 2003;17:2052–4.
doi: 10.1038/sj.leu.2403092
Ikegame K, Yoshida T, Yoshihara S, Daimon T, Shimizu H, Maeda Y, et al. Unmanipulated haploidentical reduced-intensity stem cell transplantation using fludarabine, busulfan, low-dose antithymocyte globulin, and steroids for patients in non-complete remission or at high risk of relapse: a prospective multicenter phase I/II study in Japan. Biol Blood Marrow Transplant. 2015;21:1495–505.
doi: 10.1016/j.bbmt.2015.04.012
Remberger M, Sundberg B. Low serum levels of total rabbit-IgG is associated with acute graft-versus-host disease after unrelated donor hematopoietic stem cell transplantation: results from a prospective study. Biol Blood Marrow Transplant. 2009;15:996–9.
doi: 10.1016/j.bbmt.2009.04.013
Chawla S, Dharmani-Khan P, Liu Y, Prokopishyn N, Amlish Munir M, Griffiths C, et al. High serum level of antithymocyte globulin immediately before graft infusion is associated with a low likelihood of chronic, but not acute, graft-versus-host disease. Biol Blood Marrow Transplant. 2014;20:1156–62.
doi: 10.1016/j.bbmt.2014.04.007
Jamani K, Dabas R, Kangarloo SB, Prokopishyn NL, Luider J, Dharmani-Khan P, et al. Rabbit antithymocyte globulin serum levels: factors impacting the levels and clinical outcomes impacted by the levels. Biol Blood Marrow Transplant. 2019;25:639–47.
doi: 10.1016/j.bbmt.2018.12.065
Admiraal R, Nierkens S, de Witte MA, Petersen EJ, Fleurke GJ, Verrest L, et al. Association between anti-thymocyte globulin exposure and survival outcomes in adult unrelated haemopoietic cell transplantation: a multicentre, retrospective, pharmacodynamic cohort analysis. Lancet Haematol. 2017;4:e183–91.
doi: 10.1016/S2352-3026(17)30029-7
Kaida K, Ikegame K, Ikemoto J, Murata R, Irie R, Yoshihara S, et al. Soluble interleukin-2 receptor level on day 7 as a predictor of graft-versus-host disease after HLA-haploidentical stem cell transplantation using reduced-intensity conditioning. Int J Hematol. 2014;99:463–70.
doi: 10.1007/s12185-014-1542-x
Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, et al. Consensus conference on acute GVHD grading. Bone Marrow Transplant. 1994;1995(15):825–8.
Remberger M, Sundberg B. Rabbit-immunoglobulin G levels in patients receiving thymoglobulin as part of conditioning before unrelated donor stem cell transplantation. Haematologica. 2005;90:931–8.
pubmed: 15996931
Kanda Y. Investigation of the freely available easy-to-use software “EZR” for medical statistics. Bone Marrow Transplant. 2013;48:452–8.
doi: 10.1038/bmt.2012.244
Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015;21:389-401.e1.
doi: 10.1016/j.bbmt.2014.12.001
Shiratori S, Ohigashi H, Ara T, Yasumoto A, Goto H, Nakagawa M. High lymphocyte counts before antithymocyte globulin administration predict acute graft-versus-host disease. Ann Hematol. 2021;100:1321–8.
doi: 10.1007/s00277-020-04347-1
Bouazzaoui A, Spacenko E, Mueller G, Huber E, Schubert T, Holler E, et al. Steroid treatment alters adhesion molecule and chemokine expression in experimental acute graft-vs.-host disease of the intestinal tract. Exp Hematol. 2011;39:238-49.e1.
doi: 10.1016/j.exphem.2010.11.006
Kennedy VE, Chen H, Savani BN, Greer J, Kassim AA, Engelhardt BG, et al. Optimizing antithymocyte globulin dosing for unrelated donor allogeneic hematopoietic cell transplantation based on recipient absolute lymphocyte count. Biol Blood Marrow Transplant. 2018;24:150–5.
doi: 10.1016/j.bbmt.2017.08.029
Heelan F, Mallick R, Bryant A, Radhwi O, Atkins H, Huebsch L, et al. Does lymphocyte count impact dosing of anti-thymocyte globulin in unrelated donor stem cell transplantation? Biol Blood Marrow Transplant. 2020;26:1298–302.
doi: 10.1016/j.bbmt.2020.02.026
Gauntner TD, Brunstein CG, Cao Q, Weisdorf D, Warlick ED, Jurdi NE, et al. Association of CD34 cell dose with 5-year overall survival after peripheral blood allogeneic hematopoietic cell transplantation in adults with hematologic malignancies. Transplant Cell Ther. 2022;28:88–95.
doi: 10.1016/j.jtct.2021.11.004
Fujioka T, Tamaki H, Ikegame K, Yoshihara S, Taniguchi K, Kaida K, et al. Frequency of CD4(+)FOXP3(+) regulatory T-cells at early stages after HLA-mismatched allogeneic hematopoietic SCT predicts the incidence of acute GVHD. Bone Marrow Transplant. 2013;48:859–64.
doi: 10.1038/bmt.2012.232