TABLE 4.
Baseline disease characteristics—efficacy-evaluable population (Phase 1b/2a Study).
| Characteristics | Placebo (n = 11) | Efzofitimod | |||
|---|---|---|---|---|---|
| Tertiles a | Total n = 21 | ||||
| [805; 3,638] (n = 7) | [3,638; 6,198] (n = 7) | [6,198; 14,860] (n = 7) | |||
| Duration of disease (years), median (range) | 2.83 (0.5, 8.4) | 4.41 (1.5, 19.6) | 3.48 (0.6, 15) | 1.89 (0.5, 28) | 3.55 (0.5, 28) |
| Immunomodulator Use, n | 6 | 2 | 1 | 3 | 6 |
| Prednisone equivalent dose b (mg/day), mean (SD) | 13.6 (4.5) | 11.4 (3.78) | 13.6 (6.27) | 14.3 (3.45) | 13.1 (4.6) |
| ppFVC, mean (SD) | 78.1 (11.7) | 66.3 (8.54) | 84.6 (8.32) | 83.4 (18.8) | 78.1 (14.9) |
| KSQ-Lung score, mean (SD) | 42.4 (10.6) | 50.6 (11.4) | 53.8 (13.3) | 48.3 (15.3) | 50.9 (13) |
AUC, area under the concentration-time curve; FVC, forced vital capacity; KSQ, king sarcoidosis questionnaire; n = number of participants with the measure; OCS, oral corticosteroids; ppFVC, percent-predicted forced vital capacity; SD, standard deviation.
Baseline measurements were defined as the last measurement assessed on or before the first dose date. If multiple measurements were taken on Day 1, the last measurement before the first dose was used as baseline.
a
Tertiles are calculated by AUC, from Day 1 to Week 24.
b
Any OCS, that is not prednisone was converted to a prednisone-equivalent OCS.