The efficacy of anti-lymphocyte serum (ALS) induction remains inconclusive in liver transplantation (LT) due to poorly designed trials.
To determine whether induction with ALS is superior to no induction in adult LT.
Randomized controlled trial including 206 adults (aged >15 years) and comparing tacrolimus monotherapy (TAC, n=109) versus tacrolimus plus intraoperative single high-dose (9 mg/kg) of rabbit anti-T-lymphocyte globulins (ATLG; n=97). All patients underwent similar follow-up, including biopsies scored according to the Banff classification. Graft rejection was considered clinically relevant and treated if pathologic and biochemical changes were consistent. The primary endpoint was minimization of immunosuppression to monotherapy; secondary endpoints included biopsy-proven rejection, clinical rejection, as well as patient (PS) and graft (GS) survival.
At 1 year, 79 (96.3%) of the 81 ATLG patients and 101 (99.0%) of the 102 TAC patients were steroid-free (p=0.585); 28 (34.6%) ATLG and 31 (30.4%) TAC patients were on double-therapy 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), respectively. Though there were significantly fewer moderate-to-severe rejections (Banff 6-9) on Day 7 in the ATLG group than in the TAC group (10.0% vs. 24.0%, p=0.019), the cumulative proportion of patients experiencing clinically relevant rejection (16.5% ATLG vs. 22.0% TAC, p=0.379), steroid-sensitive rejection (13.4% ATLG vs. 17.4% TAC, p=0.448), steroid-resistant rejection (2.1% ATLG vs. 3.7% TAC, p=0.686), and chronic rejection (1.0% ATLG vs. 0.9% TAC, p=1.000) was similar in both groups.
ATLG induction did not significantly impact immunosuppressive load, treated rejection, PS, and GS at 1 year following LT. Long-term results are required to assess the possible benefits of ATLG on immunosuppressive load and tolerance induction.