Efficacy
Patients can have confidence in cutaquig®’s demonstrated efficacy
Zero serious bacterial infections in two clinical trials1,2#
*Serious bacterial infections included bacterial pneumonia, bacteremia/sepsis, osteomyelitis/septic arthritis, visceral abscess and bacterial meningitis¹.
#Data from two clinical trials (SCGAM-01 trial: 61 PID patients, 64 weekly infusions; SCGAM-04 trial: 25 PID patients, 32 weekly infusions)
##Data from the SCGAM-01 trial: 61 PID patients, 64 weekly infusions
References:
1. Kobayashi, R.H., 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, 2019. 10:40.
2. Latysheva, E., et al., Efficacy and safety of octanorm (cutaquig®) in adults with primary immunodeficiencies with predominant antibody deficiency: a prospective, open-label study. Immunotherapy. 2020. 12(5):299-309.
3. EMA. Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg). 2015; Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-humannormal-immunoglobulin-subcutaneous/intramuscular-administration-scig/imig_en.pdf.
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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
▼ This medicinal product is subject to additional monitoring.
