Outcomes in kidney transplant recipients treated with immediate‐release tacrolimus capsules versus extended‐release tacrolimus capsules: A cohort study. Issue 1 (27th November 2022)

• Record Type: Journal Article
• Authors: Ha, Yoonhee P.; Divard, Gillian; Mitra, Nandita; Putt, Mary E.; Pallet, Nicolas; Loupy, Alexandre; Anglicheau, Dany; Trofe‐Clark, Jennifer; Legendre, Christophe; Bloom, Roy D.; Reese, Peter P.
• Is Part Of: Clinical transplantation. Volume 37:Issue 1(2023)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2022-11-27
• Subjects: adherence -- extended‐release tacrolimus -- immediate‐release tacrolimus -- immunosuppression -- kidney transplantation -- tacrolimus; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ctr.14840
• Languages: English
• ISSNs: 0902-0063

Abstract

Abstract: Introduction: Prior randomized trials and observational studies have generally reported similar outcomes in kidney transplant recipients (KTRs) treated with immediate‐release tacrolimus (IR‐TAC) versus extended‐release tacrolimus (ER‐TAC). However, many of these previous studies focused on patients with low immunological risks, had small sample sizes and brief follow‐up periods, and excluded outcomes associated with graft loss, such as chronic rejection. Methods: To address these limitations, we conducted a cohort study of 848 KTRs at a single transplantation center who had generally high immunological risks and were treated with either IR‐TAC capsules (589 patients, 65.9%) or ER‐TAC capsules (289 patients, 34.1%). All patients received their designated maintenance immunosuppressive regimen for at least 3 months post‐transplantation. Afterwards, tacrolimus formulation was at the discretion of each patient's transplant nephrologist. For the two treatment groups, we compared the hazards of experiencing a composite outcome of acute or chronic antibody‐mediated rejection (AMR), acute or chronic T‐cell‐mediated rejection, de novo DSA, and/or graft loss over a 3‐year period starting at 3 months post‐transplantation. Results: In a multivariable Cox proportional hazards regression model, KTRs treated with IR‐TAC capsules had an increased hazard of experiencing the composite outcome when compared to patients treated with ER‐TAC capsules; however, this result was not significant (adj HR 1.24, 95% CI .92–1.68, p = .163). Similar results were obtained with inverse probability of treatment weighting (IPTW) using a propensity score (adj HR 1.25, 95% CI .93–1.68, p = .146). Conclusion: These findings suggest that when compared to IR‐TAC capsules, ER‐TAC capsules do not reduce the hazard of poor outcomes in KTRs with generally high immunological risks.