Total Skin Score (TSS) and corticosteroid response to ECP treatment
| Parameter . | Week 12 . | P . | Week 24 . | ||
|---|---|---|---|---|---|
| ECP, n = 48 . | Control, n = 47 . | ECP, n = 48 . | Control, n = 47* . | ||
| Median percent change from baseline in TSS | −14.5 | −8.5 | .48 | −31.4 | N/A |
| > 50% reduction in corticosteroid dose, n (%)† | 12 (25) | 6 (12.8) | .13 | 19 (39.6) | N/A |
| > 50% reduction in corticosteroid dose and > 25% improvement in TSS, n (%) | 4 (8.3) | 0 (0.0) | .04 | 11 (22.9) | N/A |
| > 50% reduction in corticosteroid dose and final corticosteroid dose of < 10 mg/day, n (%)† | 10 (20.8) | 3 (6.4) | .04 | 17 (35.4) | N/A |
| Parameter . | Week 12 . | P . | Week 24 . | ||
|---|---|---|---|---|---|
| ECP, n = 48 . | Control, n = 47 . | ECP, n = 48 . | Control, n = 47* . | ||
| Median percent change from baseline in TSS | −14.5 | −8.5 | .48 | −31.4 | N/A |
| > 50% reduction in corticosteroid dose, n (%)† | 12 (25) | 6 (12.8) | .13 | 19 (39.6) | N/A |
| > 50% reduction in corticosteroid dose and > 25% improvement in TSS, n (%) | 4 (8.3) | 0 (0.0) | .04 | 11 (22.9) | N/A |
| > 50% reduction in corticosteroid dose and final corticosteroid dose of < 10 mg/day, n (%)† | 10 (20.8) | 3 (6.4) | .04 | 17 (35.4) | N/A |
Results based on MITT population, defined as all randomized patients who received at least 1 study treatment and who had at least 1 postbaseline TSS. The last available TSS was used for patients who did not have a TSS at week 12.
The large numbers of patients who discontinued the study in the control arm precluded statistical comparison for week 24.
In the ECP group, 41 patients were receiving treatment with corticosteroids at baseline and 38 had doses recorded at week 12. In the control group, 43 patients were receiving treatment with corticosteroids at baseline and 39 had doses recorded at week 12.
In both groups, the last known dose of corticosteroids was used when the week 12 dose was missing.