Real-World Study of Once-Daily, Extended-Release Tacrolimus Versus Twice-Daily, Immediate-Release Tacrolimus in Kidney Transplantation: Clinical Outcomes and Healthcare Resource Utilization

Bing Ho, Hardik Bhagat, Jason J. Schwartz, Kofi Atiemo, Amna Daud, Raymond Kang, Samantha E. Montag, Lihui Zhao, Edward Lee, Anton I. Skaro, Daniela P. Ladner*

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Introduction: Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. Methods: This was a retrospective, single-center analysis (February–June 2016) using data from Northwestern University’s Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. Results: A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5%) and 3 (5.5%) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6–10 ng/mL), and number of required dose adjustments were also similar. Conclusion: Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. Funding: Astellas Pharma Global Development, Inc. Plain Language Summary: Plain language summary available for this article.

Original languageEnglish (US)
JournalAdvances in Therapy
DOIs
StatePublished - Jan 1 2019

Fingerprint

Tacrolimus
Kidney Transplantation
Delivery of Health Care
Language
Transplantation
Transplants
Kidney
Biopsy
Social Adjustment
Graft Rejection
Graft Survival
Glomerular Filtration Rate
Hospitalization
Outpatients
Demography

Keywords

  • Calcineurin inhibitor
  • Glomerular filtration rate (GFR)
  • Graft survival
  • Immunosuppressant
  • Kidney (allograft) function/dysfunction
  • Patient characteristics
  • Tacrolimus
  • Urology

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{e7307422beb14868b2fdb5a2b742de0b,
title = "Real-World Study of Once-Daily, Extended-Release Tacrolimus Versus Twice-Daily, Immediate-Release Tacrolimus in Kidney Transplantation: Clinical Outcomes and Healthcare Resource Utilization",
abstract = "Introduction: Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. Methods: This was a retrospective, single-center analysis (February–June 2016) using data from Northwestern University’s Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. Results: A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5{\%}) and 3 (5.5{\%}) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6–10 ng/mL), and number of required dose adjustments were also similar. Conclusion: Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. Funding: Astellas Pharma Global Development, Inc. Plain Language Summary: Plain language summary available for this article.",
keywords = "Calcineurin inhibitor, Glomerular filtration rate (GFR), Graft survival, Immunosuppressant, Kidney (allograft) function/dysfunction, Patient characteristics, Tacrolimus, Urology",
author = "Bing Ho and Hardik Bhagat and Schwartz, {Jason J.} and Kofi Atiemo and Amna Daud and Raymond Kang and Montag, {Samantha E.} and Lihui Zhao and Edward Lee and Skaro, {Anton I.} and Ladner, {Daniela P.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s12325-019-00904-x",
language = "English (US)",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Health Communications Inc.",

}

Real-World Study of Once-Daily, Extended-Release Tacrolimus Versus Twice-Daily, Immediate-Release Tacrolimus in Kidney Transplantation : Clinical Outcomes and Healthcare Resource Utilization. / Ho, Bing; Bhagat, Hardik; Schwartz, Jason J.; Atiemo, Kofi; Daud, Amna; Kang, Raymond; Montag, Samantha E.; Zhao, Lihui; Lee, Edward; Skaro, Anton I.; Ladner, Daniela P.

In: Advances in Therapy, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Real-World Study of Once-Daily, Extended-Release Tacrolimus Versus Twice-Daily, Immediate-Release Tacrolimus in Kidney Transplantation

T2 - Clinical Outcomes and Healthcare Resource Utilization

AU - Ho, Bing

AU - Bhagat, Hardik

AU - Schwartz, Jason J.

AU - Atiemo, Kofi

AU - Daud, Amna

AU - Kang, Raymond

AU - Montag, Samantha E.

AU - Zhao, Lihui

AU - Lee, Edward

AU - Skaro, Anton I.

AU - Ladner, Daniela P.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Introduction: Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. Methods: This was a retrospective, single-center analysis (February–June 2016) using data from Northwestern University’s Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. Results: A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5%) and 3 (5.5%) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6–10 ng/mL), and number of required dose adjustments were also similar. Conclusion: Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. Funding: Astellas Pharma Global Development, Inc. Plain Language Summary: Plain language summary available for this article.

AB - Introduction: Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. Methods: This was a retrospective, single-center analysis (February–June 2016) using data from Northwestern University’s Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. Results: A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5%) and 3 (5.5%) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6–10 ng/mL), and number of required dose adjustments were also similar. Conclusion: Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. Funding: Astellas Pharma Global Development, Inc. Plain Language Summary: Plain language summary available for this article.

KW - Calcineurin inhibitor

KW - Glomerular filtration rate (GFR)

KW - Graft survival

KW - Immunosuppressant

KW - Kidney (allograft) function/dysfunction

KW - Patient characteristics

KW - Tacrolimus

KW - Urology

UR - http://www.scopus.com/inward/record.url?scp=85064454982&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85064454982&partnerID=8YFLogxK

U2 - 10.1007/s12325-019-00904-x

DO - 10.1007/s12325-019-00904-x

M3 - Article

C2 - 30941724

AN - SCOPUS:85064454982

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

ER -