Clinical and laboratory end points
| . | N (%) . | RR (95% CI) . | |
|---|---|---|---|
| Rituximab (n = 32) . | Placebo (n = 26) . | ||
| Efficacy end points (at any time) | |||
| Treatment failure (composite)* | 21 (65.6) | 21 (80.8) | 0.81 (0.59, 1.11) |
| Any platelet count < 50 × 109/L | 17 (53.1) | 16 (61.5) | 0.86 (0.55, 1.35) |
| Rescue treatment | 14 (43.8) | 17 (65.4) | 0.67 (0.41, 1.08) |
| Significant bleeding† | 7 (21.9) | 6 (23.1) | 0.95 (0.36, 2.48) |
| Platelet count end points | |||
| Complete platelet count response‡ | 17 (53.1) | 12 (46.2) | 1.15 (0.68, 1.95) |
| Overall platelet count response§ | 20 (62.5) | 19 (73.1) | 0.86 (0.60, 1.22) |
| Mean platelet count without rescue treatment (mean) | 131 × 109/L | 96 × 109/L | P < .0001 |
| . | N (%) . | RR (95% CI) . | |
|---|---|---|---|
| Rituximab (n = 32) . | Placebo (n = 26) . | ||
| Efficacy end points (at any time) | |||
| Treatment failure (composite)* | 21 (65.6) | 21 (80.8) | 0.81 (0.59, 1.11) |
| Any platelet count < 50 × 109/L | 17 (53.1) | 16 (61.5) | 0.86 (0.55, 1.35) |
| Rescue treatment | 14 (43.8) | 17 (65.4) | 0.67 (0.41, 1.08) |
| Significant bleeding† | 7 (21.9) | 6 (23.1) | 0.95 (0.36, 2.48) |
| Platelet count end points | |||
| Complete platelet count response‡ | 17 (53.1) | 12 (46.2) | 1.15 (0.68, 1.95) |
| Overall platelet count response§ | 20 (62.5) | 19 (73.1) | 0.86 (0.60, 1.22) |
| Mean platelet count without rescue treatment (mean) | 131 × 109/L | 96 × 109/L | P < .0001 |
Proportion of patients with any platelet count < 50 × 109/L, rescue treatment, or significant bleeding (primary efficacy end point).
Significant bleeding was defined as bleeding grade 2 from any anatomic site as defined by the ITP bleeding score.11
Complete response = platelet count > 100 × 109/L at 6 months without rescue treatment.
Overall response = platelet count > 30 × 109/L and doubling from baseline at 6 months without rescue treatment.