Session Time: 9:59am-10:40am
Presentation Time: 10:00am-10:07am
Location: Main Channel
*Purpose: Previous trials have not examined 2-year longitudinal differences in patient-reported outcomes (PRO) between belatacept (BELA)- and tacrolimus (TAC)-based therapies in adult kidney transplant (KTx) patients (pts). The BEST Trial (Belatacept-based Early Steroid-withdrawal Trial) was designed to compare 2 BELA-based early steroid withdrawal (ESW) regimens with a TAC-based ESW regimen across 2 years. Our hypothesis was that patients on BELA will have fewer immunosuppressant-related symptoms and improved quality of life (QoL).
*Methods: This longitudinal, multisite study was conducted under an FDA IND and IRB across 8 sites. All pts received mycophenolate therapy and 5 days of steroids. Pts were randomized to 3 groups: alem+BELA, r-ATG+BELA, r-ATG+TAC. Pts completed 2 PRO measures at baseline, 1-year, and 2-years (MEMPHIS, MTSOSD-59R).
*Results: Intent to treat analyses on 138 pts with 2-year follow-up were completed. Those on BELA-based therapies generally reported higher gains in QoL across 2-years; and, reported lower probability of adverse events at 2-years. No significant differences were observed between groups for total QoL, misc side effects, GI distress, emotional burden, life responsibilities, or mobility. Alem+BELA and r-ATG+BELA groups were compared to r-ATG+TAC group at 2-years and differences in individual symptom scores were observed.
*Conclusions: CNI free/ESW Bela-based regimens resulted in a tendency toward improved PROs across 2-years. All baseline symptoms improved with transplant except GI distress in the TAC-based regimen, which increased at 2-years. Neurologic, GI, and mobility symptoms were reported less frequently in the BELA-based regimens. Psychological symptoms (e.g., restlessness, anxiety, mood changes) were higher in bela-based regimens relative to TAC-based regimens. Sores on lips and warts on hands/feet were more frequently observed in bela-based regimens at 2-years, which may be related to increased viral infections. Bela-based regimens continued to have a decreased risk of trembling hands relative to TAC-based regimens. Table 1. Comparison of Symptom Scores by Treatment Group at 2 years
To cite this abstract in AMA style:Rohan JM, Leone J, Woodle E, Kaufman D, Shields A, Wiseman A, Matas A, West-Thielke P, King E, Alloway R. Patient-Reported Outcomes in a Prospective Multicenter Trial of Belatacept-Based CNI- and Corticosteroid-Free Immunosuppression Regimens in Kidney Transplantation: A Prospective Analysis Across Two Years [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/patient-reported-outcomes-in-a-prospective-multicenter-trial-of-belatacept-based-cni-and-corticosteroid-free-immunosuppression-regimens-in-kidney-transplantation-a-prospective-analysis-across-two-ye/. Accessed June 15, 2021.
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