Corticosteroid dosing
| . | Group 1 ≥12 y to <18 y n = 18 . | Group 2 ≥6 y to <12 y n = 12 . | Group 3 ≥2 y to <6 y n = 15 . | All patients N = 45 . |
|---|---|---|---|---|
| Duration of exposure to corticosteroids (days) | ||||
| Mean (SD) | 70.7 (73.9) | 76.6 (56.7) | 86.3 (55.6) | 77.5 (62.8) |
| Median (range) | 46.5 (8.0-342.0) | 68.5 (18.0-196.0) | 77.0 (19.0-195.0) | 65.0 (8.0-342.0) |
| Completely tapered off by, n (%) [95% CI] | ||||
| Day 28 | 2 (11.1) [1.4-34.7] | 1 (8.3) [0.2-38.5] | 1 (6.7) [0.2-31.9] | 4 (8.9) [2.5-21.2] |
| Day 56 | 9 (50.0) [26.0-74.0] | 4 (33.3) [9.9-65.1] | 4 (26.7) [7.8-55.1] | 17 (37.8) [23.8-53.5] |
| EOT | 11 (61.1) [35.7-82.7] | 6 (50.0) [21.1-78.9] | 11 (73.3) [44.9-92.2] | 28 (62.2) [46.5-76.2] |
| ≥50% dose reduction by, n (%) [95% CI] | ||||
| Day 28 | 10 (55.6) [30.8-78.5] | 6 (50.0) [21.1-78.9] | 8 (53.3) [26.6-78.7] | 24 (53.3) [37.9-68.3] |
| Day 56 | 15 (83.3) [58.6-96.4] | 7 (58.3) [27.7-84.8] | 12 (80.0) [51.9-95.7] | 34 (75.6) [60.5-87.1] |
| EOT | 15 (83.3) [58.6-96.4] | 10 (83.3) [51.6-97.9] | 14 (93.3) [68.1-99.8] | 39 (86.7) [73.2-94.9] |
| Mean (SD) percentage dose change at | ||||
| Day 28 | −39.2 (52.1) | −41.7 (36.3) | −25.3 (71.6) | −35.2 (55.3) |
| Day 56 | −56.8 (49.6) | −52.7 (46.7) | −47.4 (64.2) | −52.6 (53.2) |
| EOT | −56.6 (52.0) | −63.2 (33.2) | −61.8 (63.4) | −60.1 (51.1) |
| . | Group 1 ≥12 y to <18 y n = 18 . | Group 2 ≥6 y to <12 y n = 12 . | Group 3 ≥2 y to <6 y n = 15 . | All patients N = 45 . |
|---|---|---|---|---|
| Duration of exposure to corticosteroids (days) | ||||
| Mean (SD) | 70.7 (73.9) | 76.6 (56.7) | 86.3 (55.6) | 77.5 (62.8) |
| Median (range) | 46.5 (8.0-342.0) | 68.5 (18.0-196.0) | 77.0 (19.0-195.0) | 65.0 (8.0-342.0) |
| Completely tapered off by, n (%) [95% CI] | ||||
| Day 28 | 2 (11.1) [1.4-34.7] | 1 (8.3) [0.2-38.5] | 1 (6.7) [0.2-31.9] | 4 (8.9) [2.5-21.2] |
| Day 56 | 9 (50.0) [26.0-74.0] | 4 (33.3) [9.9-65.1] | 4 (26.7) [7.8-55.1] | 17 (37.8) [23.8-53.5] |
| EOT | 11 (61.1) [35.7-82.7] | 6 (50.0) [21.1-78.9] | 11 (73.3) [44.9-92.2] | 28 (62.2) [46.5-76.2] |
| ≥50% dose reduction by, n (%) [95% CI] | ||||
| Day 28 | 10 (55.6) [30.8-78.5] | 6 (50.0) [21.1-78.9] | 8 (53.3) [26.6-78.7] | 24 (53.3) [37.9-68.3] |
| Day 56 | 15 (83.3) [58.6-96.4] | 7 (58.3) [27.7-84.8] | 12 (80.0) [51.9-95.7] | 34 (75.6) [60.5-87.1] |
| EOT | 15 (83.3) [58.6-96.4] | 10 (83.3) [51.6-97.9] | 14 (93.3) [68.1-99.8] | 39 (86.7) [73.2-94.9] |
| Mean (SD) percentage dose change at | ||||
| Day 28 | −39.2 (52.1) | −41.7 (36.3) | −25.3 (71.6) | −35.2 (55.3) |
| Day 56 | −56.8 (49.6) | −52.7 (46.7) | −47.4 (64.2) | −52.6 (53.2) |
| EOT | −56.6 (52.0) | −63.2 (33.2) | −61.8 (63.4) | −60.1 (51.1) |
Safety set; 95% confidence limits were calculated from the Fisher exact test.
EOT, end of treatment; SD, standard deviation.