Table 2.
fSCIG dosing and infusion parameters at inclusion and 12 months by age subgroups
| Parameter, median (range) | < 18 years | 18–64 years | ≥ 65 years | Total | ||||
|---|---|---|---|---|---|---|---|---|
| Inclusion | 12 months | Inclusion | 12 months | Inclusion | 12 months | Inclusion | 12 months | |
| (n = 15) | (n = 12) | (n = 120) | (n = 99) | (n = 21) | (n = 17) | (n = 156) | (n = 128) | |
| Total fSCIG dose at the most recent infusion, g | 10.0 (2.5–30.0) | 13.8 (5.0–40.0) | 25.0 (10.0–60.0) | 30.0 (10.0–60.0) | 30.0 (20.0–50.0) | 30.0 (15.0–50.0) | 25.0 (2.5–60.0) | 30.0 (5.0–60.0) |
| fSCIG total monthly dose, g | 15.0 (10.0–30.0) | 15.0 (5.0–40.0) | 30.0 (10.0–75.0) | 30.0 (10.0–60.0) | 30.0 (20.0–50.0) | 30.0 (1.0–50.0) | 30.0 (10.0–75.0) | 30.0 (1.0–60.0) |
| fSCIG dose, g/kg/month | 0.476 (0.106–0.833) | 0.500 (0.341–0.645) | 0.423 (0.169–0.816) | 0.425 (0.116–0.857) | 0.410 (0.250–0.545) | 0.349 (0.012–0.526) | 0.427 (0.106–0.833) | 0.412 (0.012–0.857) |
| Total fSCIG infusion volumea, mL | 100 (25–300) | 138 (50–400) | 300 (10–600) | 300 (25–600) | 300 (40–350) | 300 (30–400) | 250 (10–600) | 300 (25–600) |
| fSCIG maximum infusion rate, mL/h | 100 (10–300) | 160 (50–300) | 300 (60–300) | 300 (60–320) | 300 (240–300) | 275 (240–300) | 300 (10–300) | 300 (50–320) |
| Number of infusion sites | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) |
| Infusion location, n (%) | ||||||||
| Upper abdomen | 5 (33.3) | 3 (25.0) | 63 (52.5) | 54 (54.0) | 4 (19.0) | 6 (32.4) | 72 (46.2) | 62 (48.4) |
| Lower abdomen | 5 (33.3) | 0 (0) | 35 (29.2) | 15 (15.2) | 11 (52.4) | 3 (17.6) | 51 (32.7) | 18 (14.1) |
| Thigh | 4 (26.7) | 4 (33.3) | 3 (2.5) | 5 (4.5) | 0 | 0 | 7 (4.5) | 9 (6.6) |
| Other | 1 (6.7) | 5 (41.7) | 0 | 0 | 0 | 0 | 1 (0.6) | 5 (3.9) |
| Unknown | 0 | 0 | 19 (15.8) | 26 (26.3) | 6 (28.6) | 9 (50.0) | 25 (16.0) | 35 (27.0) |
| Infusion interval, n (%) | ||||||||
| Weekly | 0 | 0 | 1 (0.8) | 1 (1.0) | 0 | 0 | 1 (0.6) | 1 (0.8) |
| Every 2 weeks | 0 | 0 | 16 (13.3) | 11 (11.2) | 0 | 0 | 16 (10.3) | 11 (8.7) |
| Every 3 weeks | 3 (20.0) | 0 | 27 (22.5) | 19 (19.4) | 1 (4.8) | 1 (5.9) | 31 (19.9) | 20 (15.7) |
| Every 4 weeks | 12 (80.0) | 12 (100.0) | 68 (56.7) | 61 (62.2) | 17 (81.0) | 13 (76.5) | 97 (62.2) | 86 (67.7) |
| Otherb | 0 | 0 | 4 (3.3) | 6 (6.1) | 2 (9.5) | 3 (17.6) | 6 (3.8) | 9 (7.1) |
| NAc | 0 | 0 | 4 (3.3) | 0 | 1 (4.8) | 0 | 5 (3.2) | 0 |
| IgG serum trough level, median (IQR) g/L | 7.0 (6.6–9.4) | 8.1 (7.1–8.8) | 8.4 (7.1–9.5) | 8.2 (7.3–9.3) | 6.9 (4.8–9.0) | 7.0 (4.6–8.5) | 8.1 (6.8–9.5) | 8.1 (7.2–9.2) |
fSCIG facilitated subcutaneous immunoglobulin, Ig immunoglobulin, IQR interquartile range
aTotal infusion volume over all sites per patient. bOther: comprises intervals up to every 35 weeks. cNot applicable, as the patients received only one fSCIG infusion to date