Pharmacoepidemiol Risk Manage.  2024 Sep;16(2):182-191. 10.56142/perm.24.0017.

Effectiveness and Safety of TacrolimusMycophenolate Combination Therapy vs. Tacrolimus Monotherapy in Pediatric Liver Transplantation

• Cheon SY
• Jeong Jh
• Choi JY
• Cho EJ
• Baek JH
• Yi NJ
• Lee JY

• KMID: 2564482
• DOI: http://doi.org/10.56142/perm.24.0017

Abstract

Objective
The clinical outcome of mycophenolate (MPA) combined with tacrolimus in pediatric liver transplantation (LT) are not well understood. This study aimed to evaluate the effectiveness and safety of MPA and tacrolimus combination therapy compared to tacrolimus monotherapy in this population.
Methods
This retrospective cohort study included pediatric LT patients who received at least 30 consecutive days of either tacrolimus and MPA (± steroid) combination therapy and their propensity score matched patients on tacrolimus (± steroid) monotherapy between 2010 and 2021. Incidence of acute rejection and immunosuppressantrelated adverse events (AEs) were compared between the two groups.
Results
Among 130 pediatric LT patients, 32 were assigned to each group. Within one-year post-transplant, there were no statistically significant differences in acute rejection (9.4% vs. 12.5%; p = 0.502) or overall AEs (84.4% vs. 65.6%; p = 0.149) between the combination and control groups. However, a significantly higher rate of AEs leading to immunosuppressant discontinuation was observed in the combination group (62.5% vs. 3.1%; p < 0.001). No significant differences were found in severe infections, cytomegalovirus infections, post-transplant lymphoproliferative disease, or renal dysfunction. Although tacrolimus exposure was similar, the concentration/dose ratio was lower in the combination group at 1 month (1.8 ± 5.4 vs. 3.4 ± 3.8, p = 0.040).
Conclusion
While acute rejection and overall AE rates did not differ significantly between the two groups, the MPA combination group had a higher rate of therapy discontinuation due to AEs. Further studies with larger populations are needed to confirm these findings.

Keyword

Pediatric; Liver transplant; Tacrolimus; Mycophenolate; Acute rejection; Adverse events