Comparison of Early Conversion to LCP‐Tacrolimus (ENVARSUS XR) to Immediate‐Release Tacrolimus in Lung Transplant Recipients
Fuente:
Wiley Open Access
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , |
|---|---|
| Format: | Artículo Open Access |
| Veröffentlicht: |
Wiley
2025
|
| Schlagworte: | |
| Online-Zugang: | |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| _version_ | 1867009602295431168 |
|---|---|
| author | Tyler C. Lewis Perry Hotchkis Adrian Wong Victoria Lamaina Emily Fitzpatrick Avital Stiefel Juliana Ohanian Joseph R. Schnier Melissa Lesko Darya Rudym Jake G. Natalini Luis F. Angel |
| author_facet | Tyler C. Lewis Perry Hotchkis Adrian Wong Victoria Lamaina Emily Fitzpatrick Avital Stiefel Juliana Ohanian Joseph R. Schnier Melissa Lesko Darya Rudym Jake G. Natalini Luis F. Angel Tyler C. Lewis Perry Hotchkis Adrian Wong Victoria Lamaina Emily Fitzpatrick Avital Stiefel Juliana Ohanian Joseph R. Schnier Melissa Lesko Darya Rudym Jake G. Natalini Luis F. Angel |
| collection | Wiley Open Access |
| contents | Comparison of Early Conversion to LCP‐Tacrolimus (ENVARSUS XR) to Immediate‐Release Tacrolimus in Lung Transplant Recipients Tyler C. Lewis Perry Hotchkis Adrian Wong Victoria Lamaina Emily Fitzpatrick Avital Stiefel Juliana Ohanian Joseph R. Schnier Melissa Lesko Darya Rudym Jake G. Natalini Luis F. Angel Clinical Transplantation ABSTRACTTacrolimus is highly effective at preventing allograft rejection and prolonging survival after lung transplantation. However, erratic pharmacokinetics may limit efficacy and predispose to greater adverse effects. We conducted a prospective, open‐label trial of lung transplant recipients who underwent early conversion (within 30 days) to LCP tacrolimus (LCPT, n = 40) and compared first‐year outcomes to an historical control of patients who remained on immediate‐release tacrolimus (IRT, n = 24). Subjects were converted 1:1 from IRT to LCPT. The first dose of LCPT overlapped with the last morning dose of IRT. Conversion to LCPT occurred at a median of 17.5 [IQR 12–25] days. The conversion dose ratio was 1.0 mg:mg [IQR 0.75–1.50] at 14 days. At 1 year, there were no differences between LCPT and IRT in the incidence of biopsy‐proven (12.5% vs. 25.0%, p = 0.30) or clinically treated (20.0% vs. 25.0%, p = 0.64) acute cellular rejection. However, the severity of any biopsy‐proven rejection was significantly higher in the IRT cohort (27.5% vs. 54.2%, p = 0.03). Although not achieving statistical significance, de novo donor‐specific antibodies were more commonly observed in the LCPT group (20.0% vs. 4.2%, p = 0.14). Despite this, the incidence of antibody‐mediated rejection (7.5% vs. 0.0%, p = 0.29) and early‐onset chronic lung allograft dysfunction (7.5% vs. 9.1%, p = 1.00) were similar. The incidence of chronic kidney disease stage 4 or greater at 1‐year was similar (7.5% vs. 12.5%, p = 0.66). In conclusion, early conversion to LCPT was feasible and similarly efficacious to IRT in a cohort of lung transplant recipients.Trial Registration: ClinicalTrials.gov identifier: NCT04420195 10.1111/ctr.70159 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| doi_str_mv | 10.1111/ctr.70159 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_ctr_70159 |
| institution | Wiley Open Access |
| license_str_mv | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Comparison of Early Conversion to LCP‐Tacrolimus (ENVARSUS XR) to Immediate‐Release Tacrolimus in Lung Transplant Recipients Tyler C. Lewis Perry Hotchkis Adrian Wong Victoria Lamaina Emily Fitzpatrick Avital Stiefel Juliana Ohanian Joseph R. Schnier Melissa Lesko Darya Rudym Jake G. Natalini Luis F. Angel Clinical Transplantation Comparison of Early Conversion to LCP‐Tacrolimus (ENVARSUS XR) to Immediate‐Release Tacrolimus in Lung Transplant Recipients Tyler C. Lewis Perry Hotchkis Adrian Wong Victoria Lamaina Emily Fitzpatrick Avital Stiefel Juliana Ohanian Joseph R. Schnier Melissa Lesko Darya Rudym Jake G. Natalini Luis F. Angel Clinical Transplantation ABSTRACTTacrolimus is highly effective at preventing allograft rejection and prolonging survival after lung transplantation. However, erratic pharmacokinetics may limit efficacy and predispose to greater adverse effects. We conducted a prospective, open‐label trial of lung transplant recipients who underwent early conversion (within 30 days) to LCP tacrolimus (LCPT, n = 40) and compared first‐year outcomes to an historical control of patients who remained on immediate‐release tacrolimus (IRT, n = 24). Subjects were converted 1:1 from IRT to LCPT. The first dose of LCPT overlapped with the last morning dose of IRT. Conversion to LCPT occurred at a median of 17.5 [IQR 12–25] days. The conversion dose ratio was 1.0 mg:mg [IQR 0.75–1.50] at 14 days. At 1 year, there were no differences between LCPT and IRT in the incidence of biopsy‐proven (12.5% vs. 25.0%, p = 0.30) or clinically treated (20.0% vs. 25.0%, p = 0.64) acute cellular rejection. However, the severity of any biopsy‐proven rejection was significantly higher in the IRT cohort (27.5% vs. 54.2%, p = 0.03). Although not achieving statistical significance, de novo donor‐specific antibodies were more commonly observed in the LCPT group (20.0% vs. 4.2%, p = 0.14). Despite this, the incidence of antibody‐mediated rejection (7.5% vs. 0.0%, p = 0.29) and early‐onset chronic lung allograft dysfunction (7.5% vs. 9.1%, p = 1.00) were similar. The incidence of chronic kidney disease stage 4 or greater at 1‐year was similar (7.5% vs. 12.5%, p = 0.66). In conclusion, early conversion to LCPT was feasible and similarly efficacious to IRT in a cohort of lung transplant recipients.Trial Registration: ClinicalTrials.gov identifier: NCT04420195 10.1111/ctr.70159 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| title | Comparison of Early Conversion to LCP‐Tacrolimus (ENVARSUS XR) to Immediate‐Release Tacrolimus in Lung Transplant Recipients |
| topic | Clinical Transplantation |
| url | https://onlinelibrary.wiley.com/doi/10.1111/ctr.70159 |