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https://www.readbyqxmd.com/read/28332959/de-novo-donor-specific-antibody-formation-in-tacrolimus-based-mycophenolate-versus-mammalian-target-of-rapamycin-immunosuppressive-regimens
#1
Zain Mithani, Jane Gralla, Oluwafisayo Adebiyi, Patrick Klem, James E Cooper, Alexander C Wiseman
OBJECTIVES: De novo donor-specific antibody formation posttransplant is associated with decreased graft survival. It is not known whether mammalian target of rapamycin inhibitors may be advantageous or detrimental compared with mycophenolate in the prevention of de novo donor-specific antibody formation. MATERIALS AND METHODS: We compared 66 kidney and kidney-pancreas transplant recipients who received tacrolimus, mammalian target of rapamycin inhibitor, and prednisone (group 1; 36 of whom received everolimus and 30 of whom received sirolimus) versus 132 patients who received tacrolimus, mycophenolate, and prednisone (group 2) matched for age, sex, race, and type/timing of transplant from 2007 to 2012...
March 22, 2017: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/28300419/dried-blood-spot-validation-of-five-immunosuppressants-without-hematocrit-correction-on-two-lc-ms-ms-systems
#2
Remco A Koster, Herman Veenhof, Rixt Botma, Alle Tjipke Hoekstra, Stefan P Berger, Stephan Jl Bakker, Jan-Willem C Alffenaar, Daan J Touw
AIM: Hematocrit (Ht) effects remain a challenge in dried blood spot (DBS) sampling. The aim was to develop an immunosuppressant DBS assay on two LC-MS/MS systems covering a clinically relevant Ht range without Ht correction. RESULTS: The method was partially validated for tacrolimus, sirolimus, everolimus, cyclosporin A and fully validated for mycophenolic acid on an Agilent and Thermo LC-MS/MS system. Bias caused by Ht effects were within 15% for all immunosuppressants between Ht levels of 0...
March 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28282713/treatment-of-an-early-kaposi-s-sarcoma-case-post-kidney-transplantation-by-sirolimus-a-case-report
#3
Farzaneh Najafi, Parichehr Kafaie, Hossein Neamatzadeh
Kaposi᾽s sarcoma (KS) can develop in 0.06% to 4.1% of kidney transplant recipients. Here we describe a case of 50-year-old man who developed KS a few months after kidney transplantation. After transplantation, he had delayed graft function and was managed by anti-thymocyte globulin (ATG) for five days. At the discharge, his immunosuppressive therapy was prednisolone 20 mg/day, tTacrolimus (Pprograf®) 4 mg/day, and mycophenolate mofetil (MMF) 2 gr/day, while he also took Vvalcyte and diltiazem. Once diagnosed with KS, the Prograf® (tacrolimus)  was replaced by prednisolone (5 mg/day) and sirolimus (2 mg/day)...
February 2017: Acta Medica Iranica
https://www.readbyqxmd.com/read/28258588/gastrostomy-tube-placement-for-long-term-oral-drug-administration-in-non-human-primates
#4
Jong-Min Kim, Jun-Seop Shin, Byoung-Hoon Min, Jung-Sik Kim, Il-Hee Yoon, Won-Young Jeong, Ga-Eul Lee, Min-Sun Kim, Ju-Eun Kim, Chung-Gyu Park
BACKGROUND: Non-human primates (NHPs) are often used as recipients in preclinical transplantation research that in most cases involves administration of various drugs including immunosuppressants. Long-term oral drug administration, particularly tacrolimus, is challenging in the transplant recipient NHPs. Oral drug administration method using the mixture of drug and fruit juice has been used in NHPs, but this is not always effective in all monkeys. To those monkeys who are poorly compliant, oral drug administration in restraint or administration using gastrostomy tube should be necessary...
March 3, 2017: Xenotransplantation
https://www.readbyqxmd.com/read/28205445/severe-hypertriglyceridemia-induced-by-sirolimus-treated-with-medical-management-without-plasmapheresis
#5
Kazuhiko Kido, Rickey A Evans, Anil Gopinath, Jeremy D Flynn
Hypertriglyceridemia and hyperlipidemia are the most remarkable metabolic complications seen with long-term sirolimus therapy. We report the case of a 36-year-old woman status post bilateral lung transplantation on a maintenance immunosuppression regimen of sirolimus, tacrolimus, and prednisone who presented with status migrainosus, chest pain, abdominal discomfort, and triglyceride levels greater than 4425 mg/dL. In previously reported cases of severe hypertriglyceridemia that developed on maintenance sirolimus therapy, plasmapheresis has been utilized as an early strategy to rapidly lower triglycerides in order to minimize the risk of acute complications such as pancreatitis, but our case was managed medically without plasmapheresis...
January 1, 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28182044/efficacy-and-safety-of-early-tacrolimus-conversion-to-sirolimus-after-kidney-transplantation-long-term-results-of-a-prospective-randomized-study
#6
A E El-Agroudy, S M Alarrayed, S M Al-Ghareeb, E Farid, H Alhelow, S Abdulla
We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile...
January 2017: Indian Journal of Nephrology
https://www.readbyqxmd.com/read/28121742/association-of-baseline-viral-serology-and-sirolimus-regimens-with-kidney-transplant-outcomes-a-14-year-registry-based-cohort-study-in-the-united-states
#7
Alfonso H Santos, Michael J Casey, Wen Xuerong, Karl L Womer
BACKGROUND: The risks for transplant outcomes associated with baseline viral serostatus in kidney transplant recipients (KTR) on sirolimus have not been widely studied. METHODS: We performed a cohort-study of 61 590 adult KTR in 2000 to 2013. We used Cox regression models to determine the adjusted hazard ratio (aHR) of patient death, death-censored graft loss and posttransplant malignancy associated with the baseline serostatus (+ or -: hepatitis B core [HBc], hepatitis C virus [HCV], Epstein-Barr virus [EBV], or cytomegalovirus [CMV]) in KTR on sirolimus (SRL) + mycophenolate (MPA) or SRL + tacrolimus (Tac), relative to the control-regimen: Tac + MPA...
February 2017: Transplantation
https://www.readbyqxmd.com/read/28104702/il-2-promotes-early-treg-reconstitution-after-allogeneic-hematopoietic-cell-transplantation
#8
Brian C Betts, Joseph Pidala, Jongphil Kim, Asmita Mishra, Taiga Nishihori, Lia Perez, Jose Leonel Ochoa-Bayona, Farhad Khimani, Kelly Walton, Ryan Bookout, Michael Nieder, Divis K Khaira, Marco Davila, Melissa Alsina, Teresa Field, Ernesto Ayala, Frederick L Locke, Marcie Riches, Mohamed Kharfan-Dabaja, Hugo Fernandez, Claudio Anasetti
Graft-versus-host disease remains a major cause of transplant-related mortality. Interleukin-2 plus sirolimus synergistically reduces acute graft-versus-host disease in rodents and promotes regulatory T-cells. This phase II trial tested the hypothesis that interleukin-2 would facilitate STAT5 phosphorylation in donor T-cells, expand regulatory T-cells, and ameliorate graft-versus-host disease. Between 4/16/2014-12/19/2015, 20 patients received interleukin-2 (200,000IU/m2 thrice weekly, days 0 to +90) with sirolimus (5-14ng/ml) and tacrolimus (3-7ng/ml) after HLA-matched related or unrelated allogeneic hematopoietic cell transplantation...
January 19, 2017: Haematologica
https://www.readbyqxmd.com/read/28097735/autoimmune-enteropathy-and-hepatitis-in-pediatric-heart-transplant-recipient
#9
Kimberly Lewis, Ryan Butts, J Antonio Quiros, Michelle Hudspeth, Katherine Twombley, Andrew Savage, Sally Self, Ali Burnette, Shaoli Sun
AIE is a rare disorder in children that presents with severe diarrhea and malabsorption, caused by immune-mediated damage to intestinal mucosa. AIE is often associated with various syndromes of immunodeficiency including IPEX syndrome (immune dysregulation, polyendocrinopathy and enteropathy, X-linked). Dysfunctional T regulatory cells are the source of pathology in both IPEX syndrome and AIE as they are essential in maintaining tolerance to self-antigens and eliminating autoreactive B cells. This case report describes a 10-year-old cardiac transplant and total thymectomy patient on chronic immunosuppression with tacrolimus that presented with AIE and extraintestinal manifestations of cyclical hepatitis...
January 17, 2017: Pediatric Transplantation
https://www.readbyqxmd.com/read/28081041/a-systematic-literature-review-approach-to-estimate-the-therapeutic-index-of-selected-immunosuppressant-drugs-after-renal-transplantation
#10
Jessica E Ericson, Kanecia O Zimmerman, Daniel Gonzalez, Chiara Melloni, Jeffrey T Guptill, Kevin D Hill, Huali Wu, Michael Cohen-Wolkowiez
BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence standards for approval of generic formulations. However, many immunosuppressant drugs do not have a well-defined therapeutic index (TI). METHODS: We sought to determine whether safety, efficacy, and pharmacokinetic data obtained from the medical literature through a comprehensive literature search could be used to estimate the TI of cyclosporine, tacrolimus, and sirolimus...
February 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28070711/immune-suppression-during-preclinical-drug-development-mitigates-immunogenicity-mediated-impact-on-therapeutic-exposure
#11
Jonathan Herskovitz, Josiah Ryman, Theingi Thway, Stephanie Lee, Lei Zhou, Narendra Chirmule, Bernd Meibohm, Vibha Jawa
In the clinical setting, anti-drug antibodies (ADA) against biotherapeutics can influence patient safety and interfere with product efficacy. High immunogenicity has been addressed in clinic by concomitant immune suppression, such as co-administration of methotrexate with enzyme replacement therapy (ERT) and combination tacrolimus/sirolimus treatment for prophylaxis against organ transplant rejection. This study investigates the use of such immune suppressants in mitigating ADA responses to a fully human monoclonal antibody (mAb1) in preclinical animal studies...
March 2017: AAPS Journal
https://www.readbyqxmd.com/read/28038988/serial-in-vivo-imaging-of-transplanted-allogeneic-neural-stem-cell-survival-in-a-mouse-model-of-amyotrophic-lateral-sclerosis
#12
Amit K Srivastava, Sarah K Gross, Akshata A Almad, Camille A Bulte, Nicholas J Maragakis, Jeff W M Bulte
Neural stem cells (NSCs) are being investigated as a possible treatment for amyotrophic lateral sclerosis (ALS) through intraspinal transplantation, but no longitudinal imaging studies exist that describe the survival of engrafted cells over time. Allogeneic firefly luciferase-expressing murine NSCs (Luc(+)-NSCs) were transplanted bilaterally (100,000 cells/2μl) into the cervical spinal cord (C5) parenchyma of pre-symptomatic (63day-old) SOD1(G93A) ALS mice (n=14) and wild-type age-matched littermates (n=14)...
March 2017: Experimental Neurology
https://www.readbyqxmd.com/read/27966241/clinical-analysis-of-hyperkalemic-renal-tubular-acidosis-caused-by-calcineurin-inhibitors-in-solid-organ-transplant-recipients
#13
W Lin, L Mou, H Tu, L Zhu, J Wang, J Chen, Y Hu
WHAT IS KNOWN AND OBJECTIVE: Calcineurin inhibitor (CNI)-based immunosuppressive regimen is widely used for preventing rejection in solid organ transplantation. Hyperkalemic renal tubular acidosis (RTA) caused by CNI is uncommon and potentially underappreciated. We reported four such cases to increase awareness of this risk and to provide recommendations for its management based on our experience. CASE SUMMARY: Four middle-aged males underwent solid organ transplant (two kidneys, one liver, one heart) and were treated with CNI-based immunosuppressive regimen (one cyclosporine A, three tacrolimus)...
February 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/27888534/early-steroid-withdrawal-results-in-improved-patient-and-graft-survival-and-lower-risk-of-post-transplant-cardiovascular-risk-profiles-a-single-center-10-year-experience
#14
Reynold I Lopez-Soler, Ryan Chan, Jessica Martinolich, Lisa Park, Ashar Ata, Nikolaos Chandolias, David J Conti
Long-term use of steroids results in predictable secondary effects that can lead to increased morbidity and mortality. In this study, we present 10 years worth of data of early steroid withdrawal (ESW) immunosuppression consisting of mycophenolate, sirolimus, and tacrolimus. From 2003 to 2013, 563 kidney transplant recipients were weaned off steroids prior to discharge. We compared outcomes with that of our 65 historical controls maintained on steroids. We analyzed graft and patient survival and determined the incidence of steroid-related comorbidities such as hypertension, hypercholesterolemia, diabetes, coronary artery disease, and weight gain...
November 26, 2016: Clinical Transplantation
https://www.readbyqxmd.com/read/27819684/tacrolimus-plus-sirolimus-with-or-without-atg-as-gvhd-prophylaxis-in-hla-mismatched-unrelated-donor-allogeneic-stem-cell-transplantation
#15
M A Kharfan-Dabaja, R Parody, J Perkins, O Lopez-Godino, L Lopez-Corral, L Vazquez, D Caballero, J Falantes, J Shapiro, G Ortí, P Barba, D Valcárcel, A Esquirol, R Martino, J L Piñana, C Solano, A Tsalatsanis, J Pidala, C Anasetti, J A Perez-Simón
HLA-matched related or unrelated donors are not universally available. Consequently, patients can be offered hematopoietic stem cell transplantation (HSCT) from alternative donors, including mismatched unrelated donors (MMURD), known to cause a higher incidence of acute GVHD (aGVHD) and chronic GVHD. In vivo T-cell-depletion strategies, such as antithymocyte globulin (ATG) therapy, significantly decrease the risk of GVHD. We performed a multicenter, retrospective study comparing tacrolimus (TAC) and sirolimus (SIR) with or without ATG in 104 patients (TAC-SIR=45, TAC-SIR-ATG=59) who underwent MMURD HSCT...
November 7, 2016: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/27795990/early-kidney-allograft-dysfunction-threatened-allograft-comparative-effectiveness-of-continuing-versus-discontinuation-of-tacrolimus-and-use-of-sirolimus-to-prevent-graft-failure-a-retrospective-patient-centered-outcome-study
#16
Ravinder K Wali, Heather A Prentice, Venkata Reddivari, Geroge Baffoe-Bonnie, Cinthia I Drachenberg, John C Pappadimitriou, Emilio Ramos, Matthew Cooper, Johann Jonsson, Stephen Bartlett, Matthew R Weir
BACKGROUND: Due to lack of treatment options for early acute allograft dysfunction in the presence of tubular-interstitial injury without histological features of rejection, kidney transplant recipients are often treated with sirolimus-based therapy to prevent cumulative calcineurin inhibitor exposure and to prevent premature graft failure. METHODS: We analyzed transplant recipients treated with sirolimus-based (n = 220) compared with continued tacrolimus-based (n = 276) immunosuppression in recipients of early-onset graft dysfunction (threatened allograft) with the use of propensity score-based inverse probability treatment weighted models to balance for potential confounding by indication between 2 nonrandomized groups...
September 2016: Transplantation Direct
https://www.readbyqxmd.com/read/27795987/outcomes-of-pancreatic-islet-allotransplantation-using-the-edmonton-protocol-at-the-university-of-chicago
#17
Zehra Tekin, Marc R Garfinkel, W James Chon, Lindsay Schenck, Karolina Golab, Omid Savari, J Richard Thistlethwaite, Louis H Philipson, Colleen Majewski, Silvana Pannain, Sabarinathan Ramachandran, Kourosh Rezania, Seenu M Hariprasad, J Michael Millis, Piotr Witkowski
OBJECTIVE: The aim of this study was to assess short-term and long-term results of the pancreatic islet transplantation using the Edmonton protocol at the University of Chicago. MATERIALS AND METHODS: Nine patients underwent pancreatic islet cell transplantation using the Edmonton Protocol; they were followed up for 10 years after initial islet transplant with up to 3 separate islet infusions. They were given induction treatment using an IL-2R antibody and their maintenance immunosuppression regimen consisted of sirolimus and tacrolimus...
October 2016: Transplantation Direct
https://www.readbyqxmd.com/read/27754567/adhere-randomized-controlled-trial-comparing-renal-function-in-de-novo-kidney-transplant-recipients-receiving-prolonged-release-tacrolimus-plus-mycophenolate-mofetil-or-sirolimus
#18
Oleg O Rummo, Mario Carmellini, Lionel Rostaing, Rainer Oberbauer, Maarten H L Christiaans, Christiane Mousson, Robert M Langer, Franco Citterio, Bernard Charpentier, Malcolm Brown, Gbenga Kazeem, Frank Lehner
ADHERE was a randomized, open-label, Phase IV study comparing renal function at Week 52 postkidney transplant, in patients who received prolonged-release tacrolimus-based immunosuppressive regimens. On Days 0-27, patients received prolonged-release tacrolimus (initially 0.2 mg/kg/day), corticosteroids, and mycophenolate mofetil (MMF). Patients were randomized on Day 28 to receive either prolonged-release tacrolimus plus MMF (Arm 1) or prolonged-release tacrolimus (≥25% dose reduction on Day 42) plus sirolimus (Arm 2)...
January 2017: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/27754526/-current-status-and-regulation-of-bioanalytical-laboratories-engaged-in-quantifying-immunosuppressants-for-transplant-patients-in-argentina
#19
Paula Schaiquevich, Paula Taich, Natalia Riva, Francisco Leone, Nora Paternoster, Gabriel Mato, Paulo Cáceres Guido
Objective Determine the status of analytical laboratories that quantify immunosuppressants in transplant patients who are under therapeutic drug monitoring (TDM) for these drugs in Argentina in order to identify potential perfectible areas for action. Methods A survey of the clinical and analytical TDM centers in Argentina was conducted between September 2013 and November 2014 under the direction of the Garrahan Hospital Clinical Pharmacokinetics Unit and the National Unified Central Institute for Ablation and Implant Coordination...
March 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/27748705/the-impact-of-total-gastrectomy-on-pharmacokinetics-in-kidney-transplant-immunosuppressive-drug-regimes-a-case-study
#20
Lucy Chen, Lisa Liberatore, Tom Chin, Scott Walker, Helen Fanous, Michelle M Nash, Lindita Rapi, Jennie Huckle, Jeffrey S Zaltzman, G V Ramesh Prasad
BACKGROUND: Ensuring reliable gastrointestinal drug absorption of orally-administered immunosuppressive medications posttransplant is critical to ensuring graft survival. METHODS: A 66 year old man of East Asian origin with a previous total gastrectomy was evaluated for living donor kidney transplantation. Pretransplant pharmacokinetic testing was performed to determine the most appropriate posttransplant medication strategy. The Gastrointestinal Quality of Life Index and Gastrointestinal Rating Scale questionnaires were administered to gauge immunosuppressive medication-related side effects in the absence of a stomach...
September 29, 2016: Transplantation
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