CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.
0.012
0.012 ASBIs (upper limit of 99% CI, 0.024;
P<0.0001*); 1 ASBI occurred†
2.41
2.41 infections of any kind
(95% CI, 1.89–3.03)
per patient-year spent in the
hospital due to infections
(95% CI, 0.03-0.11)
per patient-year missed from work, school,
or performing daily activities
due to illness or infection
(95% CI, 0.70-1.79)
*Significantly lower (P<0.0001) than the threshold of 1.0 per patient-year which provides substantial evidence of efficacy.
†Pneumonia was reported in a 78-year-old patient who had a specific antibody deficiency and allergic bronchopulmonary aspergillosis.
CI=confidence interval.
ASBI = Acute serious bacterial infection
Median peak IgG levels
Geometric mean trough IgG levels
IVIG=intravenous immune globulin.
In the North American clinical study, pharmacokinetic (PK) parameters were evaluated in 60 patients ≥2 years of age with PI, patients were administered intravenously at 3 to 4 week intervals with [GAMMAGARD LIQUID, Immune Globulin (Human), 10%] and then switched to weekly subcutaneous CUVITRU infusions.
See section above for Study Design information.
Weekly dosing
Q4W=every 4 weeks; QW=every week.
This model is not intended to show any efficacy results.
Every-other-week dosing
BIW=every other week; Q4W=every 4 weeks.
This model is not intended to show any efficacy results.
LQI=Life Quality Index; TSQM=Treatment Satisfaction Questionnaire for Medication.
*TSQM-9, P<0.001; LQI, P=0.008.
Review Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with CUVITRU.
See how CUVITRU had low rates of systemic adverse reactions and low incidence of local adverse reactions (ARs).1,2
References