Table VI. Pruritus at baseline and changes in pruritus visual analog scale.
| All patients (n = 96) | Only skin involvement (n = 25)* | Erythroderma (n = 40) | Lymphadenopathy (n = 55)† | Blood involvement (n = 37)‡ | Higher blood tumor burden (n = 13)§ | |
|---|---|---|---|---|---|---|
| Patients with at least moderately severe pruritus at baseline¶ | ||||||
| n | 65 | 18 | 30 | 39 | 24 | 9 |
| Baseline VAS, mean (SD) | 68.5 (21.0) | 67.9 (22.2) | 78.6 (18.0)** | 69.9 (20.4) | 67.7 (18.7) | 75.1 (19.0) |
| Best change in VAS, mean (SD) | −38.4 (27.8) | −43.1 (23.8) | −40.0 (32.8) | −33.9 (30.8)** | −36.3 (27.1) | −37.9 (30.8) |
| CMRP | 28 (43.1) | 10 (55.6) | 12 (40.0) | 11 (28.2)** | 10 (41.7) | 3 (33.3) |
| Patients with severe pruritus at baseline†† | ||||||
| n | 36 | 11 | 22 | 22 | 12 | 7 |
| Baseline VAS, mean (SD) | 84.5 (10.7) | 82.9 (9.4) | 87.5 (10.2)** | 84.7 (11.5) | 83.7 (9.7) | 83.7 (9.1) |
| Best change in VAS, mean (SD) | −48.9 (27.9) | −52.8 (22.0) | −47.9 (33.4) | −45.9 (31.7) | −48.6 (26.4) | −44.9 (31.8) |
| CMRP | 19 (52.8) | 8 (72.7) | 11 (50.0) | 9 (40.9) | 5 (41.7) | 3 (42.9) |
VAS, visual analog scale; SD, standard deviation; CMRP, clinically meaningful reduction in pruritus (defined as a decrease in VAS score of ≥ 30 for ≥ 2 consecutive cycles for patients with moderate-to-severe pruritus at baseline).
*Patients without definitive lymphadenopathy and blood involvement.
†Patients with ≥ 1 lymph node ≥ 1.5 cm by conventional measurements or ≥ 1.0 cm by spiral computed tomography scan.
‡Sézary cells > 5% of lymphocytes.
§Sézary cell counts > 1000 cells/μL and/or Sézary cells > 20% of lymphocytes.
¶Baseline score of ≥ 30 mm.
**Indicates significantly different (p ≤ 0.05) distribution from the alternative category: patients with or without only skin involvement, erythroderma, lymphadenopathy, blood involvement or higher blood tumor burden.
††Baseline score of ≥ 70mm.