Patient Recorded Outcomes (PROs) After Kidney Transplantation: Envarsus vs Tacrolimus (Multicenter Transplant Alliance Cohort)

Document Type

Conference Proceeding

Publication Date

6-1-2023

Publication Title

Am J Transplant

Abstract

Purpose: The goal of this study was to compare Patient Reported Outcomes (PROs) after kidney transplantation in patients receiving either Envarsus (once daily longacting tacrolimus) or conventional twice daily tacrolimus (BID Tac). Methods: In this prospective, non-randomized clinical trial at 5 centers in the US, patients transplanted between 8/23/2019 and 3/7/2022 were given either Envarsus or BID Tac primarily based on their insurance coverage for the drugs. At 4 and 12 months after transplantation, patients answered 2 questionnaires: The Calcineurin Inhibitor-Related Symptoms (CIRS) survey (5 common side effects) and The Transplant Related Symptoms (TRS) survey (15 common post-transplant symptoms). The primary endpoint was number of patients with one or more symptoms scored as moderate/severe/very severe (Mod/Sev/VSev) at 12 months analyzed using multivariable models adjusted for age, race, sex, and transplant center. Results: Of the 274 patients enrolled, 2 died, 69 withdrew from the study before 12 months or failed to complete their 12-month survey, and 203 completed both surveys at 12 months. Ten patients originally on Envarsus converted to BID Tac for insurance reasons and were analyzed in the BID Tac group at 12 months. Of the 203, 17% were African American, 39% female, and the mean age was 55. At 1 year, 60 (29.6%) patients had at least one Mod/Sev/VSev CIRS with the most common being hand trembling (27), muscle weakness (26), and muscle cramps (20). Fourteen (7%) patients reported at least 1 Sev/VSev CIRS. For TRS, 125 (61.6%) had at least one Mod/Sev/VSev symptom including: fatigue (47), diarrhea (45), and insomnia (43). Sixty-two (30%) reported at least one Sev/VSev and 33 had multiple symptoms. In multivariable analysis, there were no significant predictors of Mod/Sev/VSev CIRS symptoms. For TRS surveys, recipient female gender was associated with increased Mod/Sev/VSev symptoms (2.15 (1.11, 4.28) p = 0.0252) and recipient age trended toward significance (1.03, p = 0.0615). There were no differences in eGFR between Envarsus and tacrolimus at 4 or 12 months. Conclusions: One year after kidney transplantation, a Mod/Sev/VSev CIRS and TRS are common, but Sev/VSev CRS were rare. In a multivariable model for TRS, female recipients reported more severe symptoms. The type of tacrolimus drug (Envarsus vs BID Tac) did not affect symptoms. These data suggest the need for specific management approaches to address PROs after kidney transplantation. CITATION INFORMATION: Ryan R., Merzkani M., Kim D., Mai M., Heilman R., Smith B., Everly M., Stegall M. Patient Recorded Outcomes (PROs) After Kidney Transplantation: Envarsus vs Tacrolimus (Multicenter Transplant Alliance Cohort) AJT, Volume 23, Issue 6, Supplement 1. DISCLOSURES: R.J.Ryan: None. M.Merzkani: None. D.Kim: n/a. M.Mai: n/a. R.Heilman: None. B.Smith: None. M.Everly: n/a. M.Stegall: n/a.

Volume

23

Issue

6

First Page

S1167

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