Tacrolimus and single intraoperative high-dose of anti-T-lymphocyte globulins versus tacrolimus monotherapy in adult liver transplantation one-year results of an investigator-driven randomized controlled trial
| Autor: | Eliano Bonaccorsi Riani, Olga Ciccarelli, Pierre Gianello, Mina Komuta, Quirino Lai, Chantal De Reyck, Jan Lerut, Laurent Coubeau, Kevin Ackenine, Samuele Iesari, Maxime Foguenne |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty Globulin medicine.medical_treatment Biopsy Anti-T-lymphocyte globulins 030230 surgery Liver transplantation Gastroenterology Rejection Tacrolimus law.invention Induction 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Graft survival Immunosuppression Patient survival Internal medicine medicine Humans Prospective Studies Prospective cohort study Survival rate Antilymphocyte Serum Intraoperative Care biology business.industry Clinical trial Transplantation Survival Rate Treatment Outcome biology.protein 030211 gastroenterology & hepatology Surgery Female Steroids business Immunosuppressive Agents |
| Popis: | The aim of the study is to evaluate whether intra-operative induction with anti-lymphocytic serum (ALS) is superior to no induction in adult liver transplantation (LT).The efficacy of ALS induction remains inconclusive in LT, because of poorly designed trials.A randomized controlled trial was conducted, including 206 adults (15 years) and comparing tacrolimus monotherapy (TAC, n = 109) and tacrolimus plus a single, intraoperative, high-dose (9 mg/kg), rabbit anti-T-lymphocyte globulins (ATLG; n = 97). All patients had similar follow-up, including Banff-scored biopsies. Rejection was considered clinically relevant and treated if pathologic and biochemical changes were concordant. The primary endpoint was immunosuppression minimization to monotherapy; secondary endpoints were biopsy-proven rejection, clinical rejection, patient (PS) and graft (GS) survival.At 1 year, 79/81 (96.3%) ATLG and 101/102 (99.0%) TAC patients were steroid-free (P = 0.585); 28 (34.6%) ATLG, and 31 (30.4%) TAC patients were on double-drug immunosuppression (P = 0.633). One-year PS and GS of ATLG and TAC patients were 84% and 92% (P = 0.260) and 76% and 90% (P = 0.054).Despite significantly a fewer day-7 moderate-to-severe acute cellular rejections (ACR) in ATLG group (10.0% vs 24.0% in TAC group, P = 0.019), cumulative proportion of patients experiencing steroid-sensitive (11.3% ATLG vs 14.7% TAC, P = 0.539), steroid-resistant (2.1% ATLG vs 3.7% TAC, P = 0.686) and chronic rejection (1.0% ATLG vs 0.9% TAC, P = 1.000) were similar. ATLG administration brought about greater hemodynamic instability and blood products use (P = 0.001).At 1 year from LT, ATLG induction did not significantly affect immunosuppressive load, treated rejection, patient, and graft survival. The observed adverse events justify a modification of dosing and timing of ATLG infusion. Long-term results are required to judge the ATLG possible benefits on immunosuppressive load and tolerance induction. |
| Databáze: | OpenAIRE |
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