Mycophenolate ‘comparable, if not better’ than azathioprine for autoimmune hepatitis
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Key takeaways:
- Patients treated with mycophenolate mofetil were more likely to experience complete biochemical response vs. those on azathioprine.
- There was no difference in rate of steroid withdrawal between treatments.
PHILADELPHIA — Mycophenolate mofetil appeared to be more efficacious and tolerable than azathioprine in patients with autoimmune hepatitis, especially among those aged older than 50 years and with lower IgG levels, according to a presenter.
“Our goal was to provide clinicians with clearer guidance on which medication might offer better outcomes in terms of efficacy and safety in AIH patients, especially for those who fail to respond to standard therapy,” Bisher Sawaf, MD, an internal medicine resident at University of Toledo Medical Center, told Healio. “Given the lack of large-scale head-to-head trials, we aimed to synthesize the available evidence through a systematic review and meta-analysis.”
Using PubMed, Cochrane, Scopus and Web of Science, Sawaf and colleagues identified one randomized clinical trial and three cohort studies, totaling 505 patients, that compared the safety and efficacy of mycophenolate mofetil vs. azathioprine, both in combination with prednisolone, in the treatment of autoimmune hepatitis (AIH). Outcomes of interest included complete biochemical response and steroid withdrawal.
According to results presented at the ACG Annual Scientific Meeting, patients treated with mycophenolate mofetil were more likely to experience complete biochemical response (RR = 0.69; 95% CI, 0.5-0.97). No differences were found between groups in rates of steroid withdrawal.
In a subgroup analysis by age, patients older than 50 years had a significant increase in complete biochemical response with mycophenolate mofetil vs. azathioprine (RR = 1.63, 95% CI, 1-2.64), with similar results reported among patients with IgG levels lower than 2,400 mg/dL (RR = 0.61; 95% CI, 0.47-0.8). No statistically significant differences were observed between treatments among those aged younger than 50 years (RR = 1.33; 95% CI, 0.75-2.39) or with IgG levels higher than 2,400 mg/dL (RR = 0.95; 95% CI, 0.83-1.1).
“Our analysis found no significant differences in clinical remission rates between the two medications for the treatment of AIH,” Sawaf told Healio. “However, we observed a trend favoring mycophenolate mofetil in patients who did not tolerate or responded poorly to azathioprine.”
In addition, mycophenolate mofetil demonstrated a “slightly more favorable safety profile” than azathioprine, he said, with fewer adverse events reported.
“Clinicians treating patients with AIH may consider mycophenolate mofetil as a potential first-line therapy, particularly for patients who are intolerant or have had adverse reactions to azathioprine,” Sawaf told Healio. “Moreover, this analysis highlights the importance of individualized treatment plans for AIH, where both efficacy and side effects must be weighed when choosing between these immunosuppressants. Ultimately, the results suggest that mycophenolate mofetil can provide a comparable, if not better, option in certain clinical scenarios.”
He added: “Future research should focus on larger, randomized controlled trials that directly compare mycophenolate mofetil and azathioprine over longer follow-up periods to validate these findings further. Trying to investigate biomarkers that predict response to therapy would also be valuable in personalizing AIH treatment.”
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Sawaf B, et al. Comparative efficacy of mycophenolate mofetil vs. azathioprine in autoimmune hepatitis: A systematic review and meta-analysis. Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
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