The annual rate of ASBIs was 0.012 per patient-year (upper limit of 99% CI: 0.024)1
Significantly lower (P<0.0001) than the threshold of 1.0 per patient-year which provides substantial evidence of efficacy1
CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.
CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution delivers reliable protection against infection and provides steady-state Ig levels regardless of dosing frequency—and its unique administration profile makes daily to biweekly (every 2 weeks) dosing a reality for your patients.1,2
The North American study was a prospective, open-label, non-controlled, multi-center clinical trial to determine the efficacy, safety, tolerability, and pharmacokinetics (PK) of CUVITRU in 77 adult and pediatric patients ≥2 years of age with PI. The primary outcome measure was the annualized rate of ASBIs (acute serious bacterial infections), which was evaluated in 74 patients for a median treatment duration of 380.5 days (range, 30-629 days).1
The annual rate of ASBIs was 0.012 per patient-year (upper limit of 99% CI: 0.024)1
Significantly lower (P<0.0001) than the threshold of 1.0 per patient-year which provides substantial evidence of efficacy1
The annual rate of any infection was 2.41 per patient-year (95% CI: 1.89-3.03)1
1 ASBI occurred*1
0.06 days per patient-year hospitalized due to infections (95% CI: 0.03-0.11)1
The rate of hospitalizations due to infections was 0.012 per patient-year (95% CI: 0.006-0.022)1
*Pneumonia was reported in a 78-year-old patient who had a specific antibody deficiency and allergic bronchopulmonary aspergillosis.
CUVITRU provides steady-state Ig levels1
Pharmacokinetic (PK) parameters were evaluated in 60 patients ≥2 years of age with PI in the North American clinical study.1
CUVITRU was shown to significantly improve patient quality of life vs IVIG in terms of convenience (TSQM-9*; P<0.001) and treatment interference (LQI†; P=0.008)1,2
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) and Life Quality Index (LQI) questionnaire were assessed in patients ages 2 to 12 years (observer: parent) and 13 years and older (observer: patient) in the North American clinical study.1,2
TSQM-9
Treatment satisfaction was assessed with the TSQM-9 in 3 domains: Effectiveness, Convenience, and Global Satisfaction. There was statistically significant improvement in the convenience domain (P<0.001) between period 1 (IVIG 10% administration) and period 4 (CUVITRU treatment). There was no significant improvement in the perception of effectiveness and global satisfaction domains in either age group: 2 to 12 years and 13 years and older.2
LQI
Ig-related treatment burden was evaluated with the LQI questionnaire in 3 domains: Treatment Interference, Therapy-related Problems, and Therapy Settings. In that analysis, improvement in the treatment interference domain from IV to subcutaneous administration was found to be statistically significant (P=0.008) across all age groups.2 The change reported in the other domains across all age groups was not statistically significant.
Other assessments
Health-related quality of life was assessed using the Pediatric Quality of Life Inventory (PEDS-QL) questionnaire (pediatric patients) or the self-administered SF-36 survey (adult patients). Differences between IVIG and SCIG treatment were not statistically significant.1
*TSQM=Treatment Satisfaction Questionnaire for Medication.
†LQI=Life Quality Index
CUVITRU offers patients
customizable administration.1