Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, MBA, PhD, PA-C
Objective: The objective of this selective EBM review is to determine whether or not belatacept improves patient/graft survival after 1 year versus calcineurin inhibitors based regimens.
Study Design: Review of one randomized controlled trial published in 2010 and two randomized controlled trials published in 2011 were used for this review and selected based on their relevance to the clinical question.
Data Sources: Studies were found using PubMed, and Medline Plus. Outcomes Measured: All three studies measured patient/graft survival after 12 months as either a primary or secondary outcome.
Results: Vincenti et al (2010) showed belatacept to have a 97% patient/graft survival after 12 months, cyclosporine with 93% patient/graft survival rate. Adverse events (tremors) in this study where noted at 5% for belatacept and 16% for cyclosporine. In Rostaing et al (2011) RCT patient/graft survival was shown as 100% with belatacept and 99% with cyclosporine. Adverse events (pyrexia and pyelonephritis) where calculated to be 20% for belatacept and 19% for cyclosporine. In Rostaing et al (2011) post hoc analysis patient graft survival rates for belatacept where 92.8% and cyclosporine 80.8%. Adverse events in this study where 54.6% for belatacept and 67.2% for cyclosporine.
Conclusion: The results of these three RCT are inconclusive as to the efficacy of belatacept over cyclosporine in regards to patient/graft survival after 12 months.
Burns, Ashlie, "Does Belatacept Improve Patient/Graft Survival after 1 Year Versus Calcineurin Inhibitor Based Regimens?" (2016). PCOM Physician Assistant Studies Student Scholarship. 406.