CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.
Patients with primary immunodeficiency (PI) taking CUVITRU® may be able to experience more of these moments, with weekly or every-other-week infusions.1
The North American study was a prospective, open-label, noncontrolled, multicenter 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 acute serious bacterial infections (ASBIs), which was evaluated in 74 patients for a median treatment duration of 380.5 days (range, 30–629 days). The annual rate of ASBIs was 0.012 per patient-year (upper limit of 99% CI: 0.024), which is significantly lower (P<0.0001) than the threshold of 1.0 per patient-year and provides substantial evidence of efficacy.1
IVIG=intravenous immune globulin; SCIG=subcutaneous immune globulin.
*Upper limit of 99% CI, 0.024; P<0.0001; 1 ASBI occurred.
The annual rate of acute serious bacterial infections (ASBIs) was 0.012 (upper limit of 99% CI, 0.024; P<0.0001*) per patient-year
The annual rate of infections of any kind was 2.41 (95% CI: 1.89-3.03) per patient year
*Significantly lower than the threshold of 1.0 per patient-year which provides substantial evidence of efficacy.1
†Pneumonia was reported in a 78-year-old patient who had a specific antibody deficiency and allergic bronchopulmonary aspergillosis.
Treatment satisfaction was measured using the Life Quality Index questionnaire (LQI) and the Treatment Satisfaction Questionnaire for Medication (TSQM-9). The LQI was assessed for the age group 2 years to 12 years (observer: parent) and the age group 13 years and older (observer: subject) in 3 domains: Treatment Interference, Therapy-Related Problems, and Therapy Settings. The TSQM-9 was assessed in subjects aged 2 to 12 years (observer: parent) and 13 years and older (observer: subject) in 3 domains: Effectiveness, Convenience, and Global Satisfaction. Differences between scores during the intravenous study part and subcutaneous 20% study part were calculated for selected domains of the instruments.1
LQI=Life Quality Index; TSQM=Treatment Satisfaction Questionnaire for Medication.
*TSQM-9, P<0.001; LQI, P=0.008. Both TSQM-9 and LQI were assessed in patients aged 2 to 12 (with a parent observer), and in patients aged ≥13 (with the patient as the observer).
(0.042 ARs per CUVITRU infusion vs 0.302 ARs per IVIG infusion)
Of the 278 nonserious ARs (excluding infections), 83% (n=231) were rated as mild, 16% (n=45) were rated as moderate, and 1% (n=2) were rated as severe (hemoptysis and abdominal pain).
The most common adverse reactions observed in clinical trials in ≥5% of patients were: local adverse reactions including mild or moderate pain, erythema, and pruritus, and systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.
ARs can be defined as serious and non-serious, with the non-serious being mild, moderate, or severe. Mild: transient discomfort that resolves spontaneously or with minimal intervention. Moderate: cause limited impairment of function, may require therapeutic intervention, do not interfere significantly with the subject’s normal functioning level, and produce no sequelae. Severe: result in marked impairment of function that may lead to temporary inability to resume usual life pattern and/or produces sequelae which require (prolonged) therapeutic intervention.2
See Study Design.
*The median duration of once-weekly infusions was <1 hour (0.95 hours; range, 0.2-6.4 hours) in the North American study.
†Infuse first 2 infusions at 10 to 20 mL/h/site.
‡60 mL/h/site is the highest volume compared to any other conventional SCIG option.
§84.9% of infusions (N=4314) were administered using only 1 or 2 infusion sites (18.5%=1 site; 66.4%=2 sites) in the North American clinical study.
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