*Purpose: The adverse effects associated with steroid use make earlier steroid withdrawal desirable, but the optimal time for withdrawal after liver transplantation (LT) is not known. The purpose of this study was to compare outcomes between early steroid withdrawal (ESW) and late steroid withdrawal (LSW) in LT recipients.

*Methods: This was a single-center, retrospective cohort study of adult LT recipients transplanted between January 2015 – June 2018. Key exclusion criteria were steroids >1 year, multiorgan transplant, and <6 months of follow-up. ESW and LSW were defined as steroid elimination <120 days and >120 days post-transplant, respectively. ESW LT recipients were matched to LSW recipients at a 1:2 ratio based on date of LT. The primary endpoint was incidence of acute rejection at one year, defined as AST and/or ALT >2 times the upper limit of normal and requiring intervention (intensification of maintenance immunosuppression, admission, additional treatment agents). Secondary endpoints were patient and graft survival, new requirement for anti-diabetic agents, infections, BMI, and fractures at one year.

*Results: A total of 66 patients (ESW=22, LSW=44) were included, and all patients had at least one year of follow-up. The most common etiologies of liver disease were HCV, alcohol, and nonalcoholic fatty liver disease, and 53% had hepatocellular carcinoma. BMI, recipient and donor age, cold ischemic time, and creatinine were similar between groups. Most patients received tacrolimus and mycophenolate mofetil. There were no differences between groups in tacrolimus troughs or creatinine; however, mycophenolate doses were higher in the ESW group starting from month three (p=0.01). There was no difference between groups in the primary outcome of acute rejection (40.9% vs. 31.8%; p=0.47), and incidence decreased when the biochemical threshold for acute rejection was increased to five times the upper limit of normal (22.7% vs. 9.1%; p=0.15). Seven patients underwent liver biopsy and acute cellular rejection was noted in 2 vs. 3 patients (p=1.00). Of those with the primary outcome, few required more than intensification of maintenance immunosuppression (9.1% vs. 6.8%; p=1.00), and most resolved within one month (77.8% vs. 92.9%; p=0.30). Median maximum liver enzymes during rejection were 69 vs. 82 u/L (p=0.84) for AST and 139 vs. 124.5 u/L (p=0.08) for ALT. One patient received an additional agent (methylprednisolone 500 mg IV once) to treat rejection, and the episode occurred prior to steroid withdrawal. There were no graft failures during the study period and no differences between groups in new requirements for anti-hyperglycemic agents, infections, BMI or the occurrence of fractures.

*Conclusions: This study suggests that ESW before 120 days post-transplant does not lead to an increase in acute rejection. Most acute rejection was managed with intensification of immunosuppression alone and did not affect one-year graft survival. There was no change in steroid-associated adverse effects with ESW.

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