{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T00:38:48Z","timestamp":1781311128002,"version":"3.54.1"},"reference-count":26,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,12,20]],"date-time":"2019-12-20T00:00:00Z","timestamp":1576800000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec><jats:title>Study Objective<\/jats:title><jats:p>Basiliximab is an immunosuppressive monoclonal antibody used for rejection prevention following solid organ transplantation; the pharmacokinetics (PK) of basiliximab in this setting are known. Basiliximab may also be used for prophylaxis and treatment of graft\u2010versus\u2010host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT); however, the PK of basiliximab in this setting are not known. Clinical transplant providers expect variation in the volume of distribution and clearance after nonmyeloablative allogeneic transplantation (NMAT) compared with solid organ transplantation. Blood loss, organ site\u2013specific antibody accumulation, and differences in blood product use during the two transplantation approaches may generate differences in basiliximab PK. Therefore, the objective of this study was to describe the PK of basiliximab after its addition to a minimally intense NMAT regimen, in conjunction with cyclosporine, for GVHD prophylaxis in patients with hematologic malignancies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Population PK analysis of a single\u2010center, single\u2010arm, phase II clinical trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Academic cancer research center.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients<\/jats:title><jats:p>Fourteen adults with hematologic malignancies (acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, non\u2010Hodgkin\u2019s lymphoma, Hodgkin\u2019s lymphoma, myelofibrosis, or severe aplastic anemia) and undergoing NMAT with a fully HLA\u2010matched (10 of 10 antigen matched) related or unrelated donor.<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements and Main Results<\/jats:title><jats:p>Basiliximab was used in conjunction with cyclosporine to deplete activated T cells in vivo as GVHD prophylaxis. We developed a novel competitive enzyme\u2010linked immunosorbent assay (ELISA) method using recombinant interleukin\u20102 receptor alpha\u2010chain (IL\u20102Ra) and a commercially available soluble sIL\u20102R ELISA kit to permit the quantification of serum basiliximab concentrations and characterization of the PK properties of the drug in this patient population. Using a nonlinear mixed effects model with NONMEM software, a one\u2010compartment model with first\u2010order elimination best described the PK, as covariate analysis using stepwise covariate modeling did not improve the base model.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We suggest a one\u2010compartment population model with first\u2010order elimination to capture the PK profile for basiliximab for this patient population.<\/jats:p><\/jats:sec>","DOI":"10.1002\/phar.2347","type":"journal-article","created":{"date-parts":[[2019,11,19]],"date-time":"2019-11-19T13:38:17Z","timestamp":1574170697000},"page":"26-32","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pharmacokinetics of Basiliximab for the Prevention of Graft\u2010versus\u2010Host Disease in Patients Undergoing Hematopoietic Cell Transplantation with Minimal\u2010Intensity Cyclophosphamide and Fludarabine"],"prefix":"10.1002","volume":"40","author":[{"given":"Jagdeep T.","family":"Podichetty","sequence":"first","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan J.","family":"Brinda","sequence":"additional","affiliation":[{"name":"Indiana University Health Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert P.","family":"Nelson","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alissa H.","family":"Karr","sequence":"additional","affiliation":[{"name":"University of Kentucky Lexington Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagendra K.","family":"Prasad","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Quinney","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanna","family":"Foxworthy Scott","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6046-2317","authenticated-orcid":false,"given":"Patrick J.","family":"Kiel","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana"},{"name":"Indiana University Health Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-06-364265"},{"key":"e_1_2_7_3_1","unstructured":"D'SouzaA FrethamC.Current Uses and Outcomes of Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides.2017. 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