Table 3.
FAE monotherapy | FAEs + phototherapy | FAEs + MTX | All | P‐value | |
---|---|---|---|---|---|
Patients initiating FAE therapy, N | 626 | 123 | 110 | 859 | |
Prior topical and/or phototherapy, n (% of N ) | |||||
Topical therapy | 325 (51.9) | 56 (45.5) | 56 (50.9) | 437 (50.9) | 0.50* |
Topical therapy + phototherapy | 298 (47.6) | 66 (53.7) | 53 (48.2) | 417 (48.5) | |
Phototherapy | 2 (0.3) | 1 (0.8) | 0 | 3 (0.4) | |
None | 1 (0.2) | 0 | 1 (0.9) | 2 (0.2) | |
Prior systemic therapy, n (% of N ) | |||||
None | 567 (90.6) | 110 (89.4) | 86 (78.2) | 763 (88.8) | 0.0007* |
MTX | 24 (3.8) | 3 (2.4) | 11 (10.0) | 38 (4.4) | |
Acitretin | 22 (3.5) | 8 (6.5) | 8 (7.3) | 38 (4.4) | |
Biologic | 6 (1.0) | 1 (0.8) | 3 (2.7) | 10 (1.2) | |
Cyclosporine | 5 (0.8) | 0 | 1 (0.9) | 6 (0.7) | |
GC | 2 (0.3) | 1 (0.8) | 1 (0.9) | 4 (0.5) | |
Time between initial diagnosis and FAE therapy initiation [years] | |||||
Mean ± SD | 13.6 ± 12.7 | 12.6 ± 13.3 | 15.2 ± 14.2 | 13.7 ± 13.0 | 0.32** |
Median (range) | 10.1 (0−69.9) | 8.0 (0−68.4) | 10.8 (0−63.0) | 10.1 (0−69.9) | |
Years on continuous therapy with FAEs | |||||
Mean ± SD | 3.5 ± 4.2 | 3.2 ± 4.4 | 4.6 ± 4.6 | 3.6 ± 4.3 | 0.02** |
Median (range) | 1.7 (0.1−32.5) | 1.5 (0.1−30.2) | 3.4 (0.2−28.1) | 1.8 (0.1−32.5)† | |
Average DMF dose [mg/day] | |||||
Mean ± SD | 373.7 ± 182.1 | 384.0 ± 200.3 | 443.6 ± 207.1 | 384.1 ± 189.3 | 0.0016** |
Median (range) | 360 (32.6−960) | 411.4 (29.8−1030.6) | 409.7 (60−1008.1) | 367.6 (29.8−1030.6) | |
Average Fumaderm ® dose [tablets/day] | |||||
Mean ± SD | 3.3 ± 1.4 | 3.4 ± 1.5 | 3.8 ± 1.6 | 3.4 ± 1.5 | 0.0008** |
Median (range) | 3.1 (1.0−8.0) | 3.5 (1.0−8.6) | 3.4 (1.4−8.4) | 3.1 (1.0−8.6) | |
Years on continuous therapy with FAEs + phototherapy | |||||
Mean ± SD | 1.8 ± 2.6 | ||||
Median (range) | 0.7 (0.1−16.0) | ||||
Years on continuous therapy with FAEs + MTX | |||||
Mean ± SD | 2.2 ± 2.1 | ||||
Median (range) | 1.7 (0−11.1) | ||||
Average MTX dose [mg/week] | |||||
Mean ± SD | 14.5 ± 3.3 | ||||
Median (range) | 15.0 (5.0−25.0) | ||||
Cumulative dose of MTX [mg] | |||||
Mean ± SD | 1617.7 ± 1500.7 | ||||
Median (range) | 1342.0 (20.0–9266.0) |
*P‐value derived from chi‐square test; **P‐value derived from ANOVA.
†FAE treatment lasted >10 years in 9% of patients (n = 77); >20 years in 1.2% of patients (n = 10); and >30 years in 0.2% of patients (n = 2).
FAEs, fumaric acid esters; phototherapy, ultraviolet A, ultraviolet B or psoralen + ultraviolet A; MTX, methotrexate; GC, glucocorticoid; SD, standard deviation; DMF, dimethyl fumarate. Biologics included alefacept, efalizumab, etanercept and infliximab.