Drug updated on 4/10/2024
| Dosage Form | Injection (intravenous; 250 mg) |
| Drug Class | Selective T-cell costimulation blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Summary
- Belatacept (Nulojix) is indicated in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. It offers an option for optimizing kidney function and limiting certain adverse effects related to calcineurin inhibitors.
- Five studies were analyzed to gather information about the safety and efficacy of belatacept compared to other immunosuppressive agents such as tacrolimus. Tacrolimus is widely used due to its safety profile but has side effects like new-onset diabetes, nephrotoxicity, and electrolyte imbalances, whereas belatacept shows better kidney function outcomes compared to cyclosporine.
- The use of belatacept was significantly associated with lower antibody response rates post-SARS-CoV-2 vaccination among kidney transplant recipients on immunosuppressive therapies when compared with tacrolimus, indicating potentially decreased vaccine efficacy in these patients.
- A notable improvement in estimated glomerular filtration rate (eGFR) was observed following conversion from calcineurin inhibitor (CNI)-based regimens to belatacept, suggesting it could enhance renal function over the long term more effectively than calcineurin inhibitors like cyclosporine.
- However, switching from CNIs to belatacept may increase the risk of biopsy-proven acute rejection, requiring close clinical surveillance. There's also an increased risk severity of infectious diseases, including EBV-linked post-transplantation lymphoproliferative disorders under this treatment regimen, along with a decrease in response rate towards vaccines.
- No specific subgroups or population types particularly benefiting or adversely affected by belatacept were detailed across all studies reviewed. However, factors such as pre-existing conditions, concurrent medications, and overall immunity might influence outcomes, suggesting that tailored therapeutic strategies are essential when considering this drug as part of immunosuppressive therapy.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nulojix (belatacept) Prescribing Information. | 2021 | Bristol-Myers Squibb Company, Princeton, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative Safety and Efficacy of Immunosuppressive Regimens Post-kidney Transplant: A Systematic Review. | 2023 | Cureus |
| Seroconversion rates in kidney transplant recipients following SARS-CoV-2 vaccination and its association with immunosuppressive agents: A systematic review and meta-analysis. | 2023 | Clinical and Experimental Vaccine Research |
| Belatacept in kidney transplantation: what are the true benefits? A systematic review. | 2022 | Frontiers in Medicine |
| Belatacept in renal transplantation in comparison to tacrolimus and molecular understanding of resistance pattern: meta-analysis and systematic review. | 2021 | World Journal of Transplantation |
| Belatacept rescue therapy of CNI-induced nephrotoxicity, meta-analysis. | 2021 | Transplantation Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Post-operative care in the kidney transplant recipient. | 2022 | The Renal Association |
| Egyptian clinical practice guideline for kidney transplantation. | 2021 | Arab Journal of Urology |
| KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. | 2020 | Transplantation |