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 PI1,2,3,4
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
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 the pediatric clinical trial.
Kobayashi RH et al. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm])
Download the extension trial.
Kobayashi RH et al. Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig®) in the treatment of patients with primary immunodeficiencies
References:
- 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.
- Cutaquig Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.
- Kobayashi RH, et al. Immunotherapy. 2021;13(10):813–824.
- Kobayashi RH, et al., Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig®) in the treatment of patients with primary immunodeficiencies, Clinical and Experimental Immunology. 2022; 210: 91–103.