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Drug Safety Evaluations

Belatacept utilization recommendations: an expert position

, MD PhD, , MD, , MD & , MD
Pages 111-122 | Published online: 04 Dec 2012
 

Abstract

Introduction: There is a continuing need for an immunosuppressive therapy that offers a high benefit–risk profile for renal transplant recipients, supporting long-term patient and graft survival while minimizing cumulative nephrotoxicity and other side effects. Belatacept, the first biological agent developed for primary maintenance immunosuppression, was recently approved for use in Europe. Belatacept combined with corticosteroids and a mycophenolic acid is indicated for prophylaxis of graft rejection in adults receiving renal transplant. Its use is contraindicated in Epstein–Barr virus seronegative or serostatus unknown patients due to increased risk of developing posttransplant lymphoproliferative disorder.

Areas covered: This review provides practical recommendations for the use of belatacept, based on safety and efficacy data from Phase II and Phase III clinical trials in de novo kidney transplant recipients.

Expert opinion: Treatment with belatacept is associated with improved long-term graft function, making belatacept an important option for prevention of kidney allograft rejection. Furthermore, efficacy and safety data over several years of therapy suggest that belatacept is particularly suitable for long-term immunosuppression, and the selective targeting offered by belatacept may help avoid some of the non-specific chronic safety risks associated with calcineurin inhibitors and steroids. Future studies will clarify the optimal regimen for belatacept usage.

Acknowledgment

H Beaumont and C Chun from CodoMedical provided professional medical writing and editorial assistance.

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