Background and Aims: In patients with non-severe acute or chronic autoimmune hepatitis (AIH) without cirrhosis, clinical practice guidelines recommend indistinct use of prednisone or budesonide. However, budesonide is infrequently used in clinical practice. We aimed to describe its use and compare its efficacy and safety with prednisone as first-line options. Approach and Results: This was a retrospective, multicenter study of 105 naive AIH patients treated with budesonide as the first-line drug. The control group included 276 patients treated with prednisone. Efficacy was assessed using logistic regression and validated using inverse probability of treatment weighting propensity score. The median time to biochemical response (BR) was 3.1 months in patients treated with budesonide and 4.9 months in those with prednisone. The BR rate was significantly higher in patients treated with prednisone (87% vs. 49% of patients with budesonide, p < 0.001). The probability of achieving BR, assessed using the inverse probability of treatment weighting propensity score, was significantly lower in the budesonide group (OR = 0.20; 95% CI: 0.11–0.38) at any time during follow-up, and at 6 (OR = 0.51; 95% CI: 0.29–0.89) and 12 months after starting treatment (0.41; 95% CI: 0.23–0.73). In patients with transaminases <2 × upper limit of normal, BR was similar in both treatment groups. Prednisone treatment was significantly associated with a higher risk of adverse events (24.2% vs. 15.9%, p = 0.047). Conclusions: In the real-life setting, the use of budesonide as first-line treatment is low, and it is generally prescribed to patients with perceived less disease activity. Budesonide was inferior to prednisone as a first-line drug but was associated with fewer side effects.
Different reports have shown the clinical and serologic response to the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) messenger RNA (mRNA) vaccines in preventing coronavirus disease 2019 (COVID‐19) in the general population, but few studies have examined these responses in transplant recipients. We assessed the vaccine immunogenicity of two doses (100 μg) of the mRNA‐1273 vaccine (Moderna) administered with a 28‐day interval in liver transplant recipients (LTRs) at follow‐up at the Marques de Valdecilla University Hospital. LTRs without a history of COVID‐19 infection were tested for SARS‐CoV‐2 immunoglobulin G (IgG) antibodies directed against the spike protein (S) a median of 43 days after receiving the second Moderna vaccine dose. Clinical data, including immunosuppressive regimen and routine laboratory data, were obtained from the medical record of each patient up to 3 months before the date of the first vaccination. Factors associated with serologic response were evaluated through logistic regression. In total, 129 LTRs who had anti‐S results were included. Most patients were men (n = 99; 76.7%) with a median age of 63 years (interquartile range, 56–68). Alcohol (43.4%) and chronic hepatitis C (18.6%) were the most frequent causes of liver transplantation. A positive anti‐S IgG response was observed in 113 LTRs (87.6%; 95% confidence interval [CI], 80.8–92.2). A strong inverse relationship between mycophenolate mofetil use and serologic response was found (odds ratio, 0.07; 95% CI, 0.02–0.26; p = 0.001). Conclusion: Most LTRs develop an immunological response to the Moderna SARS‐CoV‐2 mRNA‐based vaccine. An immunosuppressive regimen that includes mycophenolate predicts a weak serologic response.
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