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Background: Antibodies may be used for induction of immunosuppression in heart transplantation (HT). rATG is commonly used but thrombocytopenia may prevent repeated doses and Basiliximab can be used as an alternate agent. The relative efficacy of these rATG and Basiliximab on allograft rejection and clinical outcomes is uncertain. Aim. To compare survival, incidence of rejection and episodes of infection in the first year after HT in patients who received induction with rATG alone versus patients who were unable to complete induction with rATG. Methods: We studied 72 consecutive patients who underwent HT between January 2013 and December 2014 at Papworth Hospital. Patients were grouped according to the induction therapy received; (A) 3 doses rATG (cumulative dose 1.75 mg/kg) and (B) 1 dose rATG (1 mg/kg) followed by Basiliximab (40 mg) when thrombocytopenia prevented further use of rATG. The primary endpoint was time to first episode of acute cellular rejection (ISHLT grade 2R or above). Secondary endpoints were survival, episodes of treated rejection, episodes of infection or a diagnosis of post-transplant lymphoproliferative disorder (PTLD). Results: There were significant differences in baseline characteristics and post-operative adverse events. Patients in group B were older (P = 0.03), had a higher percentage of female donors (P = 0.02), greater need for postoperative mechanical circulatory support (P = 0.01), greater need for postoperative CVVH (P < 0.01) and more frequent re-operation for bleeding (P = 0.02). The median time to first episode of rejection was 45 days in group A and 45.5 days in group B (P = 0.98). There was no difference in freedom from rejection at 1 month, 6 months and 1 year between group A (80%, 54%, 48%) and group B (82%, 61%, 61%, P = 0.32). There was no difference in the incidence of infection between groups (P = 0.62). There were no diagnoses of PTLD in either group. Survival at 1 year was 97% in group A and 80% in group B (P = 0.02). All deaths were due to primary graft dysfunction and none due to acute rejection. Conclusion: We observed no difference in the incidence of rejection in patients that were unable to complete induction with rATG and instead received Basiliximab, compared with those who completed induction with rATG. Survival was lower in patients that were received Basiliximab, probably due confounding by baseline characteristics and post-operative adverse events. Use of Basiliximab may be a safe option in patients who develop thrombocytopenia and are unable to complete induction with rATG.
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To explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2 with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of care vs current standard of care with the primary efficacy endpoint being the proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization.
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Background. Optimizing the immunosuppressive regimen is essential to improve the long-term outcomes of pediatric liver transplant recipients. Methods. We conducted a prospective, randomized, open-label study to compare the safety and efficacy of 2 treatment approaches during pediatric liver transplantation: tacrolimus monotherapy following basiliximab induction (the study group) and a dual regimen of tacrolimus plus steroids (the control group). A total of 150 patients were enrolled, with 75 patients allocated to each group. Results. In both groups, recipients achieved graft and recipient overall survival rates exceeding 93%, with no statistically significant differences between them. However, the study group exhibited a significantly lower incidence of acute cellular rejection (ACR), delayed occurrence of ACR, and an improved ACR-free survival rate at 2 y compared with the control group. Notably, the study group also showed a significant reduction in the incidence of de novo donor-specific antibodies at 3-mo and 2-y posttransplant. Furthermore, 6 mo after the transplant, the study group demonstrated significant improvements in weight-for-age Z score and height-for-age Z score. No notable differences were observed in postoperative complications or the incidence of liver fibrosis between the 2 groups. Conclusions. Basiliximab induction combine with tacrolimus (TAC) monotherapy is a safe and effective immunosuppressive regimen to reduce the episodes of ACR without influencing the development of liver fibrosis and graft and recipient survival rate after pediatric liver transplantation.
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