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Reliable protection
against infection and
steady-state Ig levels.1

EFFICACY & PK

North American study results for CUVITRU1,2

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

In the North American clinical study1:
0.012

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

2.41

The annual rate of any infection was 2.41 per patient-year (95% CI: 1.89-3.03)1

1

1 ASBI occurred*1

0.06

0.06 days per patient-year hospitalized due to infections (95% CI: 0.03-0.11)1

0.012

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

  • Patients were treated intravenously for 13 weeks with GAMMAGARD LIQUID then switched to weekly subcutaneous infusions with CUVITRU and treated for 12 to 16 weeks at 145% the IVIG dose
  • Subsequently, all patients were treated with this dose for 12 weeks after which the dose was individualized for all patients using the trough IgG levels
  • After approximately 4 months of treatment at this subcutaneous dose, a PK evaluation was conducted on all patients
  • The median peak IgG levels were lower with CUVITRU (1809 mg/dL) vs IVIG (2602 mg/dL for 3-week intervals; 2521 mg/dL for 4-week intervals)
  • The geometric mean trough levels were higher with CUVITRU (1474 mg/dL) vs IVIG (1158 mg/dL for 3-week intervals; 1019 mg/dL for 4-week intervals)
  • Weekly CUVITRU infusions resulted in relatively stable steady-state serum IgG levels vs IVIG
  • PK did not differ significantly between age groups

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

There was statistically significant improvement in the Convenience domain2

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

Improvement in the Treatment Interference domain was found to be statistically significant (P=0.008) across all age groups2

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 differences between IVIG and SCIG treatment were not statistically significant1

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

See Customized
Administration
  1. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
  2. Suez D, Stein M, Gupta S, et al. Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36(7):700-712.