Table 3.
Medical drug | Patients treated,∗ n | Patients responding,† n (%) | Combi/monotherapy | ALP pre-treatment (IU/L), mean ± SD | ALP post-treatment (IU/L), mean ± SD | p | ALT pre-treatment (IU/L), mean ± SD | ALT post-treatment (IU/L), mean ± SD | p | Discontinuation of treatment as a result of adverse effects |
---|---|---|---|---|---|---|---|---|---|---|
Corticosteroids | 43 patients treated (35 patients with available FU) | 16 (45.7) | 24 cases with combitherapy (UDCA or biologic agents), 19 with monotherapy | 276.2 ± 218.3 | 108.2 ± 54.5 | <0.001 | 76.2 ± 54.4 | 38.3 ± 26.2 | 0.001 | 0 |
UDCA | 25 patients treated (22 patients with available FU) | 12 (54.5) | 19 cases with combitherapy, 6 with monotherapy | 366.4 ± 440.9 | 146.7 ± 178.4 | 0.003 | 75.6 ± 56.7 | 38.0 ± 28.3 | 0.002 | 0 |
Azathioprin | 11 patients treated (11 with available FU) | 5 (45.5) | 10 cases with combitherapy, 1 case with monotherapy | 252.7 ± 226.5 | 154.5 ± 97.2 | 0.45 | 59.8 ± 41.1 | 71.3 ± 93.8 | 0.62 | 2 cases as a result of drug-induced hepatotoxicity and 3 cases as a result of adverse effects |
Methotrexate | 9 patients treated (9 with available FU) | 3 (33.3) | 8 cases with combitherapy, 1 case with monotherapy | 275.4 ± 522.0 | 148.5 ± 119.4 | 0.53 | 135.5 ± 176.4 | 76.6 ± 79.9 | 0.80 | 2 cases as a result of drug-induced hepatotoxicity |
MMF | 1 patient treated (1 with available FU) | 1 (100) | 1 case with combitherapy | 285.0 | 82.0 | 0.31 | 39.0 | 13.0 | 0.31 | 0 |
Cyclophosphamide | 2 patients treated (2 with available FU) | 0 (0) | 1 case with combitherapy | 80.5 ± 23.3 | 93.0 ± 2.8 | 1.0 | 38.0 ± 31.9 | 30.0 ± 26.8 | 0.43 | n. a. |
Infliximab | 1 patient treated (1 with available FU) | 0 (0) | 1 case with combitherapy | 427.0 | 770.0 | 0.31 | 80.0 | 91.0 | 0.31 | n. a. |
ALP, alkaline phosphatase; ALT, alanine aminotransferase; FU, follow-up; MMF, mycophenolate mofetil; UDCA, ursodeoxycholic acid. Level of significance: p < 0.05 (Mann-Whitney U test).
Treatment with 1 or more medical agents per patient was possible.
Patients with normalized ALP levels 12–24 months after start of therapy.