BELATACEPT -THE NEED OF THE HOUR IN INDIA !

Introduction:

Belatacept, a fusion protein composed of the Fc fragment of human IgG1 linked to the extracellular domain of cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4), selectively inhibits T-cell activation through costimulation blockade. It is a non nephrotoxic, non diabetogenic, CNI sparing  immunosuppressive agent developed to increase graft survival post renal transplantation. Despite being a part of the landmark trial -BENEFIT 008  for seven years (2007-2014), lack of access to Belatacept for patients in India, limits its use in tricky situations , where calcineurin inhibitors (tacrolimus and cyclosporine) are contraindicated for long term use.

Methods:

We studied 2 patients who had early graft dysfunction post renal transplantation due to Tacrolimus. We studied their clinical course, laboratory investigations as well as their kidney  biopsies and analyzed their progress post discontinuation of Tacrolimus and introduction of Belatacept. 

Results:

The two patients  underwent kidney transplantation in 2020 and 2023, at age 56 and 33, respectively .Their immunosuppressive regimens consisted of induction with thymoglobulin/pulse methylprednisolone  and maintenance with Tacrolimus, MMF and steroids. The first patient experienced late graft dysfunction with a serum creatinine level of 2.7 mg/dL, 4 years post transplantation. the kidney biopsy  showed dilated tubules and loss of brush border cells in the proximal convoluted tubule suggestive of Acute Tubular Injury. The second patient experienced early  graft dysfunction 2 days post transplantation with a raised serum creatinine level of 2.9 mg/dL along with raised blood pressure, generalized tonic clonic seizures and laboratory findings of anemia ,, thrombocytopenia, raised serum LDH, hyperkalemia and MRI findings of posterior reversible encephalopathy(PRES). The kidney biopsy showed endothelial swelling and presence of fibrin thrombi suggestive of Thrombotic microangiopathy (TMA) . In both cases, Tacrolimus was discontinued. Belatacept was introduced after procuring it from the western world, after ensuring EBV negative serology . Nulojix (Belatacept) was started at dose of 10 mg /kg as a monthly intravenous infusion. The renal function stabilised at 4 months post belatacept at 1.48 mg/dl and 1.8 mg/dl respectively .The  landing cost of a vial of Nulojix 250 mg was 850 Euros in India.

Conclusions:

Patients who had uncommon adverse events due to Tacrolimus, can be offered Belatacept  as a long term salvage therapy ,when logistics and cost of therapy can be managed. In the wake of globalisation of healthcare, easy access to drugs like belatacept can help save kidneys .

I have no potential conflict of interest to disclose.

I did not use generative AI and AI-assisted technologies in the writing process.