Facilitated Subcutaneous Immunoglobulin Treatment Patterns in Pediatric Patients with Primary Immunodeficiency Diseases

Figures & data

Figure 1. Flow of pediatric patients with primary immunodeficiency diseases receiving hyaluronidase-facilitated subcutaneous immunoglobulin.

During fSCIG treatment, individual patients were enrolled and some patients had medication changed or discontinued. The boxes in the middle indicate study time points (start of the study, transition to the next quarter [Q], end of the study).

fSCIG: Hyaluronidase-facilitated subcutaneous immunoglobulin; Ig20Gly: Subcutaneous immunoglobulin 20%.

Table 1. Ramp-up schedule of fSCIG in pediatric patients with primary immunodeficiency diseases.

Parameter	Overall (N = 18)	Age ≤12 years (n = 13)	Age 13–18 years (n = 5)
Patients entering the study on fSCIG, n (%)	14 (77.8%)	11 (84.6%)	3 (60.0%)
Patients switched to fSCIG, n (%)	4 (22.2%)	2 (15.4%)	2 (40.0%)
Initial dose at ramp-up period, g/kg/month, median (IQR)	0.2 (0.2–0.3)	0.3 (0.2–0.3)	0.2 (0.2–0.2)
Final dose at ramp-up period, g/kg/month, median (IQR)	0.4 (0.4–0.5)	0.4 (0.4–0.5)	0.4 (0.3–0.4)
Initial infusion volume per site, ml, median (IQR)	100.0 (56.2–100.0)	75.0 (50.0–100.0)	100.0 (100.0–100.0)
Final infusion volume per site, ml, median (IQR)	150.0 (131.2–193.8)	150.0 (100.0–150.0)	200.0 (200.0–200.0)
Initial infusion rate, ml/h, median (IQR)	10.0 (5.0–10.0)	5.0 (5.0–10.0)	10.0 (10.0–10.0)
Final infusion rate, ml/h, median (IQR)	120.0 (100.0–160.0)	120.0 (80.0–160.0)	240.0 (140.0–300.0)
Number of ramp-up infusions, median (IQR)	3.0 (2.0–3.0)	3.0 (2.0–3.0)	3.0 (3.0–3.0)
Duration of ramp-up, days, median (IQR)	35.5 (20.0–44.2)	36.0 (15.0–45.0)	35.0 (27.0–40.0)

fSCIG: Hyaluronidase-facilitated subcutaneous immunoglobulin; IQR: Interquartile range.

Table 2. Treatment parameters for fSCIG in pediatric patients with primary immunodeficiency diseases.

Parameter	Overall (N = 28)	Age ≤12 years (n = 21)	Age 13–18 years (n = 7)
Exposure to fSCIG, months, median (IQR)	15.1 (6.7–17.1)	15.9 (6.3–17.2)	11.7 (8.0–15.2)
Dose received monthly^†, g/kg, median (IQR)	0.4 (0.3–0.5)	0.4 (0.3–0.5)	0.3 (0.3–0.4)
Infusion volume per site^†, ml, median (IQR)	124.8 (100.0–152.6)	100.0 (85.2–150.0)	200.0 (155.2–200.0)
Treatment interval between doses^†, days, median (IQR)	28.0 (28.0–28.0)	28.0 (28.0–28.0)	28.0 (28.0–28.0)
Number of infusions per month^†, median (IQR)	1.0 (1.0–1.0)	1.0 (1.0–1.0)	1.0 (1.0–1.0)
Infusion rate, ml/h, median (IQR)	120.0 (98.3–163.0)	100.0 (89.3–127.0)	200.0 (169.0–270.0)
Site of injection and infusion volume per site, ml
Abdomen
n^‡ (%)	25 (89.3%)	18 (85.7%)	7 (100.0%)
Median (IQR)	139.7 (100.0–150.0)	106.3 (100.0–150.0)	200.0 (150.0–200.0)
Thigh
n^§ (%)	6 (21.4%)	5 (23.8%)	1 (14.3%)
Median (IQR)	45.4 (37.7–50.0)	50.0 (40.9–50.0)	20.6 (20.6–20.6)
Length of needle, mm, n (%)
6	4 (14.3%)	4 (19.0%)	0 (0.0%)
9	16 (57.1%)	13 (61.9%)	3 (42.9%)
12	8 (28.6%)	4 (19.0%)	4 (57.1%)

† Computed using weighted averages calculated for each patient (taking into account the length of each study period with given parameters in relation to the entire treatment time).

‡ The number of patients who received the drug in the abdomen or in the abdomen and thigh.

§ The number of patients who received the drug in the thigh or in the thigh and abdomen.

fSCIG: Hyaluronidase-facilitated subcutaneous immunoglobulin; IQR: Interquartile range.

Figure 2. Hyaluronidase-facilitated subcutaneous immunoglobulin administration schedules in pediatric patients with primary immunodeficiency diseases, overall and by treatment period.

The number of patients administering hyaluronidase-facilitated subcutaneous immunoglobulin during the given treatment period is indicated on the x-axis.

M: Month.

Figure 3. Hyaluronidase-facilitated subcutaneous immunoglobulin treatment patterns in pediatric patients with primary immunodeficiency diseases, by treatment month.

fSCIG: Hyaluronidase-facilitated subcutaneous immunoglobulin; M: Month.

Table 3. Infections in pediatric patients with primary immunodeficiency diseases receiving hyaluronidase-facilitated subcutaneous immunoglobulin.

Parameter	Overall (N = 28)	Age ≤12 years (n = 21)	Age 13–18 years (n = 7)
Number of serious bacterial infections per patient-year^†	0	0	0
Number of non-serious infections per patient-year^†	1.88 (n = 83)	2.13 (n = 70)	1.0 (n = 13)
Duration of antibiotic therapy, days, mean (SD)^‡	12.8 (17.1) (n = 11)	9.6 (10.6) (n = 9)	27.5 (38.9) (n = 2)

† Data calculated for the total sum of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) treatment duration.

‡ Data calculated for the sum of fSCIG treatment duration among patients longer than 365 days on therapy.

SD: Standard deviation.