ZERO Serious Bacterial Infections In a Phase 3 Clinical Trial

In Phase 3 Pivotal and Extension Trials

Cutaquig Demonstrated Excellent Protection From Infection and Related Outcomes in Both Adult and Pediatric Patients 2 Years of Age and Older With PI1,2,3

SUMMARY OF EFFICACY RESULTS: All Patients (Adults, Children, Adolescents)*†

Efficacy Endpoints by Patient Age Were Similar

PIVOTAL TRIAL* EXTENSION TRIAL
EFFICACY ENDPOINTS Adults (n=37) Pediatrics (n=38) Adults (n=17) Pediatrics (n=10)
SBIs—Annual rate 0 0 0.03 0
Other Infections
Annual rate (per person-year)
3.4 3.1 2.3 2.0
Absence from work, school, or daycare
Annual rate (days per person-year)
2.0 5.2 1.7 3.6
Hospitalizations Due to Infection
Number of patients
0 4 3 0
Annual rate (days per person-year) 0 0.8 0.3 0

* In the pivotal trial, as no SBIs were reported, no specific statistical analyses for SBIs were performed. Secondary endpoints assessed include the number of episodes of any other infections, along with type and severity of infection and time to resolution, days out of work/school/kindergarten/daycare due to infections, and the number of days and annual rate of hospitalization due to infections.

In the extension trial, secondary outcome measures include occurrence of SBIs, the number of episodes of any other infections, along with type and severity of infection and time to resolution, days out of work/school/kindergarten/daycare due to infections, and the number of days and annual rate of hospitalization due to infections.

Clinical study (SCGAM-01) design1,2

PK substudy diagram

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

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Download the pediatric clinical trial.

Kobayashi RH et al. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm])

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Review cutaquig safety and tolerability.

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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 Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.
  3. Kobayashi RH, et al. Immunotherapy. 2021;13(10):813–824.