CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.

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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.

Review Important Safety Information, including adverse reactions.

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

Continue Reviewing Safety Information

Review Important Safety Information, including contraindications and specific warnings and precaustions to take when prescribing and monitoring patients treated with Cuvitru.

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.

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