Consensus recommendations for use of maintenance immunosuppression in solid organ transplantation: Endorsed by the American College of Clinical Pharmacy, American Society of Transplantation, and the International Society for Heart and Lung Transplantation

Abstract

Advances in maintenance immunosuppression over the past three decades have improved solid organ transplantation outcomes dramatically. Uninterrupted access to immunosuppression is paramount to minimize rejection and maintain allograft and patient survival. There is no standardized approach to maintenance immunosuppression management. Agents used vary based on transplanted organ, center‐specific protocol, provider expertise, insurance formularies, ability to cover co‐pays, recipient characteristics and tolerability. Published data reflects this heterogeneity. Despite this limitation, maintenance immunosuppression usage cross pollinates between organ groups with standard of care agents often being used off‐label, making medication access a challenge for many transplant recipients. A multidisciplinary panel of American transplant clinicians was formed to review published literature on maintenance immunosuppression with the goal to formulate consensus recommendations for their use in specific organ groups. These consensus recommendations are intended to provide transplant clinicians with a summary of literature on maintenance immunosuppression in the modern era and to support transplant team members working to secure medication access for patients.

Age associations with tacrolimus and mycophenolic acid pharmacokinetics in stable Black and White kidney transplant recipients: Implications for health inequities

“…[16][17][18] In contrast, maintenance immunosuppression entails a prolonged therapy to prevent the recipient's immunoreactivity to the kidney allograft. 1,2,4 Minimal pharmacokinetic investigations of TAC and MPA with AE assessment relative to age have been reported during maintenance immunosuppression. It is also important to age-stratify transplant participants according to chronologic ages that includes young, middle aged, and elderly subjects to avoid skewing pharmacologic outcomes and assist in development of dosing continuums as patients age.…”

“…Limited investigations of TAC and MPA pharmacokinetics comparing young and old KTRs have been conducted within the first 6 months post‐transplant where acute clinical fluctuations are ongoing 16–18 . In contrast, maintenance immunosuppression entails a prolonged therapy to prevent the recipient's immunoreactivity to the kidney allograft 1,2,4 . Minimal pharmacokinetic investigations of TAC and MPA with AE assessment relative to age have been reported during maintenance immunosuppression.…”

“…Tacrolimus (TAC), a calcineurin inhibitor and mycophenolic acid (MPA), an anti-proliferative, is the most common regimen prescribed in adult transplant programs in the United States. [1][2][3][4] Although short-term allograft survival has improved, chronic graft survival in Black recipients is reduced compared to other races. 1,2 Pre-and post-transplant factors that may account for poorer long-term graft survival include suboptimal medication adherence, immunosuppressive pharmacokinetic and pharmacodynamic differences, genetic variance, and donor-recipient mismatches, with racial differences in immunologic responses.…”

Stem cell sources and characterization in the development of cell-based products for treating retinal disease: An NEI Town Hall report

“…Heart and lung transplantation fields have developed immunosuppression regimens; the most common being a maintenance immunosuppression (M-IMS) regimen consisting of tacrolimus, mycophenolate mofetil (MMF), and corticosteroids (temporarily) [ 99 ]. In heart transplantation the 3-year patient survival rate was found to be 97% for a regimen consisting of tacrolimus (a calcineurin inhibitor) and mycophenolic acid (MPA) (an antimetabolite), and in lung transplantation the 3-year patient survival rate was 75% for MMF in combination with anti-thymocyte globulin (ATG) induction, cyclosporine (a calcineurin inhibitor), and corticosteroids [ 99 ]. Inhibition of toll-like receptors and other immune recognition genes associated with CD4, CD8, and natural killer cell engagement have demonstrated success in animal models but have yet to be tested in the clinic [ 100 ].…”

Consensus recommendations for use of maintenance immunosuppression in solid organ transplantation: Endorsed by the American College of Clinical Pharmacy, American Society of Transplantation, and International Society for Heart and Lung Transplantation: An executive summary

“…To our knowledge, this is the only document where immunosuppressants are reviewed and presented in the context of both abdominal and thoracic transplantation. For further details including methodology, panel composition, and references, please refer the parent document 1 . A summary of consensus recommendations by medication class is below (Table 2).…”