Table 8.
Baseline | Month 3 | Month 6 | Month 12 | Month 24 | Month 36 | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Mean ± SD | Changeb [%] | P‐valuea | Changeb [%] | P‐valuea | Changeb [%] | P‐valuea | Changeb [%] | P‐valuea | Changeb [%] | P‐valuea | |
FAE monotherapy, n | 403 | 375 | 340 | 278 | 162 | 103 | |||||
SGOT [IU/L] | 23.2 ± 13.7 | 10.8 | <0.0001 | 9.3 | 0.01 | 8.6 | 0.004 | 44.0 | <0.0001 | 51.2 | <0.0001 |
SGPT [IU/L] | 28.2 ± 21.6 | 25.1 | <0.0001 | 16.6 | <0.0001 | 19.0 | 0.0005 | 38.2 | 0.008 | 38.3 | 0.001 |
GGT [IU/L] | 38.1 ± 47.4 | 14.7 | <0.0001 | 12.1 | <0.0001 | 17.0 | 0.04 | 41.4 | 0.001 | 44.5 | <0.0001 |
Creatinine [mg/dL] | 0.92 ± 0.53 | −0.2 | 0.93 | −1.1 | 0.18 | 7.6 | 0.13 | 3.2 | 0.02 | 2.2 | 0.35 |
FAEs + phototherapy, n | 89 | 75 | 66 | 55 | 33 | 13 | |||||
SGOT [IU/L] | 24.2 ± 13.3 | 11.4 | 0.02 | 0.3 | 0.95 | 8.8 | 0.15 | 28.8 | 0.01 | 36.5 | 0.08 |
SGPT [IU/L] | 28.3 ± 19.4 | 25.0 | 0.0005 | 3.8 | 0.46 | 16.5 | 0.12 | 21.3 | 0.03 | 38.1 | 0.19 |
GGT [IU/L] | 36.4 ± 31.3 | 4.8 | 0.18 | 9.1 | 0.09 | 17.6 | 0.13 | 6.9 | 0.57 | 9.0 | 0.66 |
Creatinine [mg/dL] | 0.91 ± 0.29 | 1.4 | 0.70 | 0.9 | 0.81 | 7.1 | 0.11 | 7.5 | 0.005 | 7.6 | 0.37 |
FAEs + MTX, n | 80 | 70 | 68 | 57 | 46 | 36 | |||||
SGOT [IU/L] | 25.5 ± 14.2 | 21.9 | 0.02 | 11.5 | 0.03 | 14.0 | 0.07 | 26.0 | 0.02 | 57.5 | 0.0007 |
SGPT [IU/L] | 31.6 ± 19.3 | 54.0 | 0.003 | 28.0 | 0.002 | 22.3 | 0.05 | 27.6 | 0.03 | 63.8 | 0.002 |
GGT [IU/L] | 42.6 ± 44.6 | 10.1 | 0.11 | 11.4 | 0.05 | 14.5 | 0.09 | 25.7 | 0.02 | 51.5 | 0.0007 |
Creatinine [mg/dL] | 0.94 ± 0.19 | −2.8 | 0.19 | −3.2 | 0.05 | −2.0 | 0.34 | −1.1 | 0.64 | −1.5 | 0.57 |
P‐value derived from one‐sample t‐test.
Mean percentage change from baseline.
FAEs, fumaric acid esters; phototherapy, ultraviolet A, ultraviolet B or psoralen + ultraviolet A; MTX, methotrexate; n, number of patients with available data; SD, standard deviation; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamate pyruvate transaminase; GGT, gamma‐glutamyltransferase. Normal ranges: SGOT = 10−50 IU/L, SGPT = 10−50 IU/L, GGT = 10−71 IU/L, serum creatinine = 0.70−1.20 mg/dL.