TABLE 2.
Clinical and patient data at the time of surveillance biopsy in AIH patients with standard and non–standard of care according to the treatment response
| Biochemical remission | Incomplete response | |||
|---|---|---|---|---|
| Clinical and patient data at the time point of surveillance biopsy | SOC | Non-SOC | SOC | Non-SOC |
| No. biopsies | 16 | 6 | 11 | 17 |
| Patient age at biopsy (y,) median (range) | 49 (20–66) | 58 (43–73) | 48 (26–66) | 42 (17–65) |
| Sex (female/male), number of cases | 8/8 | 6/0 | 10/1 | 10/7 |
| AIH type 1/2, number of cases | 15/1 | 5/1 | 11/0 | 12/1 |
| Non–standard-of-care therapy at time of biopsy, no. cases, n (%) | ||||
| Ciclosporin/tacrolimus | — | 1 (17%)/0 (0%) | — | 0 (0%)/6 (35%) |
| Ciclosporin/tacrolimus + mycophenolate mofetil | — | 0 (0%)/0 (0%) | — | 1 (6%)/2 (12%) |
| Mycophenolate mofetil/mercaptopurine | — | 1 (17%)/2 (33%) | — | 5 (30%)/1 (6%) |
| Everolimus/everolimus + MMF | — | 1 (17%)/1 (17%) | — | 1 (6%)/1 (6%) |
| Coimmunosuppression at time of biopsy, no. cases, n (%) | ||||
| Glucocorticoid (predniso(lo)n/budenoside) | 9 (56) | — | 10 (91) | — |
| Azathioprine | 13 (81) | — | 8 (73) | — |
| Glucocorticoid + azathioprine | 6 (38) | — | 7 (64) | — |
| Glucocorticoid + 2nd-line antimetabolite | — | — | — | — |
| Dosage (mg), range | ||||
| Ciclosporin | — | 200 | — | 50 |
| Tacrolimus | — | — | — | 2–6 |
| Mycophenolate mofetil | — | 250–500 | — | 1000–2000 |
| Mercaptopurine | — | 37.5–50 | — | 150 |
| Everolimus | — | 0.5–3.0 | — | 1.5–3.0 |
| Immunosuppression level at time of biopsy (ng/mL), range | ||||
| Tacrolimus | — | — | — | 4.4–6.0 |
| Ciclosporin | — | 135 | — | 92 |
| Everolimus | — | 2.6–3.9 | — | 2.5–5.8 |
| Duration of SOC/non-SOC at time of biopsy (mo), median (range) | 41 (6–144) | 58 (34–110) | 45 (9–157) | 36 (3–84) |
| Reason for switch to non–standard-of-care therapy, no. cases, n (%) | ||||
| Incomplete response | — | 3 (50) | — | 12 (71) |
| Intolerance/side effects | — | 3 (50) | — | 5 (29) |
| Laboratory tests at time of biopsy (times ULN), median (range) | ||||
| Alanine aminotransferase | 0.6 (0.3–1.0) | 0.7 (0.4–0.9) | 2.0 (0.4–14.3) | 2.6 (0.7–48.0) |
| Alkaline phosphatase | 0.5 (0.3–0.7); n=14 | 0.6 (0.6–0.8); n=5 | 1.0 (0.4–2.5) | 1.2 (0.5–9.4), n=11 |
| Bilirubin | 0.6 (0.3–2.1), n=15 | 0.4 (0.3–0.6), n=5 | 0.8 (0.3–3.7), n=10 | 1.0 (0.4–8.0), n=12 |
| IgG | 0.8 (0.4–1.0), n=6 | 0.7 (0.7–0.8), n=3 | 0.9 (0.6–1.9), n=7 | 1.0 (0.6–3.0), n=15 |
| Histology, median (range) | ||||
| mHAI | 1.5 (0–5) | 2 (1–6) | 6 (2–10) | 5.5 (1–13) |
| Stage of fibrosis (Ishak F) | 0 (0–5) | 0.5 (0–2) | 1 (0–6) | 3 (0–6) |
Abbreviations: AIH, autoimmune hepatitis; mHAI, modified hepatitis activity index; non-SOC, non–standard of care; SOC, standard of care; ULN, upper limit of normal.