Simulect for Induction in Heart Transplant Patients -the Double-Edged Sword

Background: Simulect (Basiliximab) is a monoclonal antibody that has been shown in solid organ transplants to significantly decrease the rates of allograft rejection. As a potent immunosuppressive agent, Simulect may also have an effect on infection, malignancy and mortality. Methods: In this retrospective study, we compared 135 patients who received Simulect (2007–2014) with 110 historical controls from 2003–2007. We excluded patients with ventricular assist devices (VAD), dual organ transplants, and repeat heart transplant. Primary outcomes of interest were rejection and infection. In secondary analyses, differences in malignancy and mortality were assessed. A time to event analysis to the outcome was used to compare the two groups. Results: Women were more likely to receive Simulect (Simulect 34.1% vs 20.9% p = .023). All other demographic data was similar between the two groups. The use of Simulect for induction was associated with a statistically significant (P < .001) reduction in rejection over the first year post-OHT. Patients not given Simulect were twice as likely to have a rejection (HR 2.05 CI 1.47, 2.87, p < .001). However, in the first year post-OHT, Simulect was also associated with an increased risk of infections (HR 1.49, CI 1.02, 2.17 P = .03) and a trend towards an increase in malignancy (HR 6.11 CI .9998, 49.8 p = .05) and mortality (HR 5.86 CI .72, 47 P = .09). Conclusions: Simulect does offer the benefit of the reduction in allograft rejection but comes with a price: a concomitant increased risk of infection and incident malignancy. Additionally the reduction in rejection is not associated with a survival benefit but rather a trend towards increased death. The use of Simulect for induction should be weighed carefully vis a vis its potential complications.