Belatacept : a new biological agent for maintenance immunosuppression in kidney transplantation.
Summary of "Belatacept : a new biological agent for maintenance immunosuppression in kidney transplantation."
Introduction: Over the past decades, calcineurin inhibitors (CNIs) have become the cornerstone of transplant immunosuppression. CNIs can exert negative effects on chronic allograft function along with cardiovascular (CV) and metabolic adverse effects. Belatacept , a selective co-stimulation blocker of T cells, is the first US FDA (06/2011) and EMEA (06/2011) approved biologic agent for maintenance immunosuppression in renal transplantation. Areas covered: The authors critically reviewed the literature over the last few years comparing belatacept with current standard of maintenance immunosuppression including CNIs in kidney transplantation. Expert opinion: Despite the increased incidence and severity of acute rejection with belatacept in Phase II and III studies, a better preservation of GFR and reduced incidence of chronic allograft nephropathy was observed as compared with CNIs. Patient and graft survivals were similar over 3- and 5-year follow-up post-transplantation. Incidence of adverse events were similar between the groups, but the risk of post-transplant lymphoproliferative disorder, predominantly involving CNS, was higher in Epstein-Barr virus seronegative recipients on belatacept, especially with a more intensive regimen. CV and metabolic end points were more favorable in belatacept versus CNI groups with similar incidences of diabetes after transplantation. Belatacept seems to be a promising drug for the future, but long-term outcomes are awaited.
Affiliation
Allegheny General Hospital, Division of Nephrology and Hypertension, Department of Medicine , 320 East North Avenue, Pittsburgh, PA 15212 , USA +1 412 359 3319 ; +1 412 359 4136 ; Ksureshk@wpahs.org.
Journal Details
This article was published in the following journal.
Name: Expert opinion on biological therapy
ISSN: 1744-7682
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22564126
- DOI: http://dx.doi.org/10.1517/14712598.2012.683522
Medical and Biotech [MESH] Definitions
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
Kidney Transplantation
The transference of a kidney from one human or animal to another.
Delayed Graft Function
General dysfunction of an organ occurring immediately following its transplantation. The term most frequently refers to renal dysfunction following KIDNEY TRANSPLANTATION.
Transplantation Conditioning
Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.
Lymphocyte Depletion
Immunosuppression by reduction of circulating lymphocytes or by T-cell depletion of bone marrow. The former may be accomplished in vivo by thoracic duct drainage or administration of antilymphocyte serum. The latter is performed ex vivo on bone marrow before its transplantation.
PubMed Articles
Five-Year Safety and Efficacy of Belatacept in Renal Transplantation.
Belatacept is a first-in-class co-stimulation blocker in development for primary maintenance immunosuppression. A Phase II study comparing belatacept with cyclosporine (CsA) for prevention of acute re...
Belatacept: a novel biologic for maintenance immunosuppression after renal transplantation.
Abstract In the past decade, the availability of new immunosuppressive maintenance therapies for use in solid organ transplantation has remained limited. Patients and clinicians have relied on immunos...
Biological agents in kidney transplantation: belatacept is entering the field.
Importance of the field: Kidney transplantation is the best treatment for end-stage kidney-disease patients. However, despite major breakthroughs in the last decades, and the progresses made with immu...
Nephrotoxicity is a major complication with immunosuppression regimens used in transplantation. Calcineurin inhibitor-sparing or reduction regimens using sirolimus (SRL) have shown variable success in...
BACKGROUND.: At 1 year, belatacept was associated with similar patient/graft survival, better renal function, and an improved cardiovascular/metabolic risk profile versus cyclosporine A (CsA) in the B...
Clinical Trials
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immuno...
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either: - unable to c...
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had kidney transplants. This study will determine whether...
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppr...
Belatacept in Liver Transplant Recipients
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a li...
