Steroids at baseline (given per Os, mg equivalent doses to prednisolone)
| TV4710/201 (PRELUDE) | 0.5 mg Edratide (N=84) | 1 mg Edratide (N=87) | 2.5 mg Edratide (N=82) | Placebo (N=87) |
|---|---|---|---|---|
| Mean | 9 | 9.7 | 9.3 | 9.9 |
| SD | 7.7 | 8.2 | 8.1 | 7.7 |
| Minimum | 0 | 0 | 0 | 0 |
| Median | 7.5 | 9.6 | 10 | 10 |
| Maximum | 40 | 30 | 35 | 30 |
| Proportion of pts with steroid dose ≤7.5 | 51.2% (43) | 48.3% (42) | 42.7% (35) | 43.68% (38) |
| Proportion of pts 7.5 < dose <20 | 38.1% (32) | 35.6% (31) | 43.9% (36) | 40.2% (35) |
| Proportion of pts with steroid dose ≥20 | 10.7% (9) | 16.1% (14) | 13.4% (11) | 16.1% (14) |
PRELUDE, A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus.