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Pediatric patients in a clinical study had consistent infection protection

Shield with check mark on, depicting infection protection.

0 pediatric patients experienced an ASBI (N=21)

in the North American clinical study post hoc analysis1,2

The impact of reduced infections for patients during the post hoc analysis of the NA clinical study2

Per age group per patient year

Bacteria icon.

≤2 infections†

Building icon with a line through it, representing fewer missed work and school days.

<2 days off of school*

Hospital icon with a line through it, representing fewer hospital stays.

0 hospitalizations‡ 

*There were no days off of school per patient-year in patients aged 2 to <5 years (95% CI, 0.00-4.61). In patients 5 to <12 years, there were 0.96 days missed (95% CI, 0.35-2.06), and in patients 12 to <16 years, there were 1.86 days missed (95% CI, 0.21-6.61).

†There were no infections per patient-year in patients aged 2 to <5 years (95% CI, 0.00-4.61). In patients 5 to <12 years, there were 1.72 infections per patient-year (95% CI, 0.85-3.05), and in patients 12 to <16 years, there were 2.00 infections per patient-year (95% CI, 0.70-4.35).

‡There were no hospitalizations per patient-year in patients aged 2 to <5 years (95% CI, 0.00-4.61), patients aged 5 to <12 years (95% CI, 0.00-0.32), and patients aged 12 to <16 years (95% CI, 0.00-0.66).

The pediatric data shown here are taken from the following clinical study post hoc analysis:

North American clinical study1: CUVITRU was studied in 77 patients (≥2 years of age) with PI in a prospective, open-label, noncontrolled, multicenter study. Efficacy was determined in 53 adults aged ≥16 years, 6 adolescents aged 12 to <16 years, and 15 children aged 2 to <12 years. The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBIs). For the overall efficacy population (N=74), the annualized ASBI rate was 0.012 (upper limit of 99% CI, 0.024) during CUVITRU treatment. Median treatment duration was 380.5 days (range, 30-629 days).

North American clinical study post hoc analysis2: Select secondary efficacy endpoints were analyzed in 21 pediatric patients from the North American clinical study.

CUVITRU demonstrated tolerability in a clinical trial

Amino acid inside of a magnifying glass icon.

Low rate of local ARs, even at higher volumes and rates, in the pooled North American and European pediatric post hoc analysis (N=50 pediatric patients)3

  • 93.7% (N=2624) of CUVITRU infusions were completed with no local adverse reactions (ARs), even at higher infusion rates and increased volume per site
  • No serious or severe ARs were reported
  • The most common ARs (≥4% of patients) were infusion site pain, erythema, pruritus, swelling, headache, and fatigue

Favorable tolerability profile in the pooled North American and European pediatric post hoc analysis3

  • More than 99% (N=2624) of CUVITRU infusions did not require any rate reduction, interruption, or discontinuation due to ARs

The pediatric data shown here are taken from the following clinical study post hoc analysis:

European clinical study1: CUVITRU was studied in 48 patients (≥2 years of age) with PI in a prospective, open-label, noncontrolled, multicenter study. The primary outcome measure was the annualized rate of ASBIs. For the overall efficacy population (N=45; 23 pediatric patients 2-18 years old), the annualized ASBI rate was 0.022 (upper limit of 99% CI, 0.049) during CUVITRU treatment. One ASBI of pneumonia was reported in a 12-year-old patient with X-Linked Agammaglobulinemia. Median treatment duration was 358 days (range, 127-399 days).

Pooled North American and European pediatric post hoc analysis3: Infusion parameters and tolerability were analyzed in 50 pediatric patients (2-17 years old) from the North American and European clinical studies.

Syringe and needle icon.

CUVITRU offers flexible dosing administration

Fastest SCIG infusion rates and fewest needlesticks without sacrificing tolerability3

  • The median infusion time was 56 minutes (range, 18-210 minutes) in the pooled North American and European pediatric post hoc analysis

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References

  1. CUVITRU. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2023. 
  2. Data on file. Takeda US Inc. 2015.
  3. Paris K, Haddad E, Borte M, et al. Tolerability of subcutaneous immunoglobulin 20%, Ig20GIy, in pediatric patients with primary immunodeficiencies. Immunotherapy. 2019;11(5):397-406.