TABLE 1.
Clinical and patient data at time of surveillance biopsy in AIH patients with non–standard of care
| Clinical and patient data at the time point of surveillance biopsy | Calcineurin inhibitors | Second-line antimetabolite | mTOR inhibitors |
|---|---|---|---|
| No. of biopsies | 10 | 9 | 4 |
| Patient age at biopsy (y) median (range) | 30 (17–53) | 55 (32–73) | 57 (43–69) |
| Sex (female/male), no. cases | 7/3 | 6/3 | 3/1 |
| AIH type 1/2, no. cases | 5/1, n=6 | 8/1 | 4/0 |
| Non–standard-of-care therapy at time of biopsy, no. cases (%) | |||
| Ciclosporin/tacrolimus | 1 (10%)/6 (60%) | — | — |
| Ciclosporin/tacrolimus + mycophenolate mofetil | 1 (10%)/2 (20%) | — | — |
| Mycophenolate mofetil | — | 6 (67) | — |
| Mercaptopurine | — | 3 (33) | — |
| Everolimus/everolimus + MMF | — | — | 2 (50%)/2 (50%) |
| Coimmunosuppression at time of biopsy, no. cases, n (%) | 9 (90) | 7 (78) | 4 (100) |
| Glucocorticoid (Predniso(lo)n/budenoside), n (%) | 1 (10) | 7 (78) | — |
| Azathioprine, n (%) | 2 (20) | — | — |
| Glucocorticoid + azathioprine, n (%) | 3 (30) | — | 2 (50) |
| Glucocorticoid + 2nd-line antimetabolite, n (%) | 3 (30) | — | 2 (50) |
| Dosage (mg), range | |||
| Ciclosporin | 50–200 | — | — |
| Tacrolimus | 2–6 | — | — |
| Mycophenolate mofetil | 1500–2000 | 250–2000 | 500–1000 |
| Mercaptopurine | — | 37.5–150 | — |
| Everolimus | — | — | 1.5–3.0 |
| Immunsuppression level at time of biopsy (ng/mL), range | |||
| Tacrolimus | 4.4–6.0 | — | — |
| Ciclosporin | 92–135 | — | — |
| Everolimus | — | — | 2.5–5.8 |
| Duration of SOC/non-SOC at time of biopsy (months), median (range) | 42 (3–110) | 50 (3–86) | 45 (34–55) |
| Reason switch to non-SOC, no. cases, n (%) | |||
| Incomplete response | 9 (90) | 3 (33) | 3 (75) |
| Intolerance/side effects | 1 (10) | 6 (66) | 1 (25) |
| Laboratory tests at time of biopsy (times upper limit of normal), median (range) | |||
| Alanine aminotransferase | 3.5 (0.8–16.5) | 1.2 (0.4–32.9) | 1.0 (0.7–48.0) |
| Alkaline phosphatase | 0.9 (0.6–2.5), n =5 | 0.8 (0.5–3.2), n =7 | 1.0 (0.6–94.0) |
| Bilirubin | 1.0 (0.6–2.9), n =5 | 0.7 (0.3–5.4), n =8 | 0.4 (0.3–8.0) |
| IgG | 1.2 (0.6–3.0), n =9 | 0.9 (0.7–1.0), n =7 | 1.1 (0.7–8.6), n =3 |
| Histology, median (range) | |||
| mHAI | 7.5 (3–13) | 3 (1–10) | 1 (1–4), n=3 |
| Stage of fibrosis (Ishak F) | 4 (0–6) | 1 (0–6) | 0 (0–1), n=3 |
Abbreviations: AIH, autoimmune hepatitis; mHAI, modified hepatitis activity index; mTOR, mammalian target of rapamycin inhibitors; non-SOC, non–standard of care; SOC, standard of care.