ZERO Serious Bacterial Infections In a Phase 3 Clinical Trial

Primary efficacy endpoint

Cutaquig Prevented Serious Bacterial Infections (SBIs) in Adult Patients with Primary Immunodeficiencies1,2.

Cutaquig adverse reactions chart

Cutaquig was studied in a prospective, open-label, non-controlled, single-arm, multicenter study in 61 patients with PI (38 adult and 23 pediatric subjects ≤16 years of age). Patients received weekly SCIg infusions with cutaquig during a 12-week wash-in/wash-out period followed by a 12-month efficacy period during which efficacy, pharmacokinetics, safety, and tolerability were evaluated (see Figure, Study Design). During the efficacy period the mean weekly dose was 175 mg/kg BW, with individual doses ranging from 60 to 390 mg/kg BW. The median duration of infusion per week was 1.5 hours.

*A rate of <1.0 per person- year was deemed adequate to demonstrate prevention, based on historical data. SBIs included bacterial pneumonia, bacteremia/sepsis, osteomyelitis/septic arthritis, visceral abscess and bacterial meningitis.

Clinical study (SCGAM-01) design1,2

PK substudy diagram

Secondary efficacy endpoints1,2

No hospitalizations
due to infections in adult patients
  • 1 Hospitalization due to respiratory syncytial virus (RSV) infection was reported in the total study population in an adolescent patient.
Absense from work or school
  • 2.6 days per person-year*
    *Total absence for whole study population
Rate of other infections
  • 3.3 per person-year
  • A total of 188 other infections (all non-serious) were observed in 52 patients
    • 73% (136/188) were mild
    • 27% (51/188) were moderate
    • 0.5% (1/188) were severe
    • One patient was hospitalized with severe bronchiolitis due to RSV infection

Rate of other infections1

Rate of other infections chart

Mild: causes discomfort but does not interfere with the patient’s routine activities
Moderate: sufficiently discomforting to interfere with the patient’s routine activities
Severe: incapacitating and prevents the pursuit of the patient’s routine activities

Download the phase 3 clinical trial.

Kobayashi RH et al. Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in the Treatment of Patients with Primary Immunodeficiencies

Download Now

Review cutaquig safety and tolerability.

Learn More

References:
  1. Kobayashi RH, Gupta S, Melamed I, et al. Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (octanorm [cutaquig®]) in the Treatment of Patients with Primary Immunodeficiencies. Front Immunol. February 2019 | Volume 10 | Article 40.
  2. Cutaquig® (Immune Globulin Subcutaneous (Human) – hipp), 16.5% solution. Full Prescribing Information. Octapharma USA, December 2019.