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Indications

What is cutaquig®?

Cutaquig® is a 16.5% immunoglobulin solution for subcutaneous (SCIg) infusion.

Mother and Daughter dressed as a superhero with a cape.

Cutaquig® is indicated for replacement therapy in adults, children and adolescents (0–18 years) in:1

Primary immunodeficiency (PID) syndromes with impaired antibody production

Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4g/l

*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines

The safety & efficacy of cutaquig® was evaluated in Phase 3 trials2-6

SCGAM-01 ²,³ Design Prospective, open-label, single-arm phase 3 study Patients 61 patients (23 paediatric, 38 adult) with primary immunodeficiencies Prior treatment Any intravenous
immunoglobulin treatment Infusions 64 weekly cutaquig infusions* Endpoint Efficacy in preventing SBIs (antibiotic use, infections), tolerability & safety (adverse events, infusion site reactions), assessment of PK profile, number and rate of other infections and HRQoL during the 52-week evaluation period
SCGAM-01 ²,³ Design Prospective, open-label, single-arm phase 3 study Patients 61 patients (23 paediatric, 38 adult) with primary immunodeficiencies Prior treatment Any intravenous
immunoglobulin treatment Infusions 64 weekly cutaquig infusions* Endpoint Efficacy in preventing SBIs (antibiotic use, infections), tolerability & safety (adverse events, infusion site reactions), assessment of PK profile, number and rate of other infections and HRQoL during the 52-week evaluation period
SCGAM-03 ⁴ Design Prospective, open-label, non-controlled, multicentre phase 3 follow-up study to SCGAM-01 Patients 27 patients (≥2 years and ≤75 years) with primary immunodeficiencies (21 from the SCGAM-01 trial and 6 de novo patients) Prior treatment SCIg (SCGAM-01 patients or de novo subjects) Infusions Weekly or every other week doses over a period of up to 4.5 years for subjects previously enrolled in Study SCGAM-01 and 12 months for de novo subjects in Canada Endpoint Medium-to-long term safety and tolerability, occurrence of SBIs, annual rate of all infections of any kind or seriousness, hospitalisations due to infections, and antibiotic use
SCGAM-03 ⁴ Design Prospective, open-label, non-controlled, multicentre phase 3 follow-up study to SCGAM-01 Patients 27 patients (≥2 years and ≤75 years) with primary immunodeficiencies (21 from the SCGAM-01 trial and 6 de novo patients) Prior treatment SCIg (SCGAM-01 patients or de novo subjects) Infusions Weekly or every other week doses over a period of up to 4.5 years for subjects previously enrolled in Study SCGAM-01 and 12 months for de novo subjects in Canada Endpoint Medium-to-long term safety and tolerability, occurrence of SBIs, annual rate of all infections of any kind or seriousness, hospitalisations due to infections, and antibiotic use
SCGAM-04 ⁵ Design Prospective, open-label, single-arm phase 3 study Patients 25 adults with primary immunodefciencies Prior treatment Any intravenous immunoglobulin treatment Infusions 32 weekly cutaquig® infusions† Endpoint Efficacy in preventing SBIs (antibiotic use, infections), tolerability & safety (adverse events, infusion site reactions), assessment of PK profile, number and rate of other infections and HRQoL during the 24-week evaluation period
SCGAM-04 ⁵ Design Prospective, open-label, single-arm phase 3 study Patients 25 adults with primary immunodefciencies Prior treatment Any intravenous immunoglobulin treatment Infusions 32 weekly cutaquig® infusions† Endpoint Efficacy in preventing SBIs (antibiotic use, infections), tolerability & safety (adverse events, infusion site reactions), assessment of PK profile, number and rate of other infections and HRQoL during the 24-week evaluation period
SCGAM-06 ⁶ Design Prospective, open-label, non-controlled, three arm, multicentre phase 3 study Patients 64 patients (≥2 years and ≤75 years) with primary immunodeficiencies Prior treatment Stable on any subcutaneous immunoglobulin treatment for a minimum of 3 months before screening Infusions 3 cohorts: Increased volume at each infusion site - patients received cutaquig® weekly and increased infusion volumes every 4 weeks (up to 100 mL/site) Increased infusion rate - patients received cutaquig® weekly and increased infusion rates every 4 weeks (up to 100 mL/h/site) Every other week dosing - patients received cutaquig® every other week at the equivalent of twice their body-weight dependent [mg/kg] weekly dose Endpoint IgG trough levels, AEs, temporally associated TEAEs during treatment period, temporally associated TEAEs during stabilisation period, TEAEs by speed of infusion, number of local infusion-site reactions and HRQOL during the 24-week evaluation period HRQOL, health-related quality of life; TEAE, treatment-emergent adverse event.
*12 infusions during the wash-in/wash-out period and 52 infusions during the evaluation period.
†8 infusions during the wash-in/wash-out period and 24 infusions during the evaluation period.
SCGAM-06 ⁶ Design Prospective, open-label, non-controlled, three arm, multicentre phase 3 study Patients 64 patients (≥2 years and ≤75 years) with primary immunodeficiencies Prior treatment Stable on any subcutaneous immunoglobulin treatment for a minimum of 3 months before screening Infusions 3 cohorts: Increased volume at each infusion site - patients received cutaquig® weekly and increased infusion volumes every 4 weeks (up to 100 mL/site) Increased infusion rate - patients received cutaquig® weekly and increased infusion rates every 4 weeks (up to 100 mL/h/site) Every other week dosing - patients received cutaquig® every other week at the equivalent of twice their body-weight dependent [mg/kg] weekly dose Endpoint IgG trough levels, AEs, temporally associated TEAEs during treatment period, temporally associated TEAEs during stabilisation period, TEAEs by speed of infusion, number of local infusion-site reactions and HRQOL during the 24-week evaluation period HRQOL, health-related quality of life; TEAE, treatment-emergent adverse event.
*12 infusions during the wash-in/wash-out period and 52 infusions during the evaluation period.
†8 infusions during the wash-in/wash-out period and 24 infusions during the evaluation period.

References:

  1. Cutaquig® European Summary of Product Characteristics. November 2023.

  2. 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.

  3. Kobayashi RH, et al. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm]). Immunotherapy. 2021;13(10):813–24.

  4. 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. Clin Exp Immunol. 2022;210(2):91-103.

  5. 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.

  6. Gupta S, et al. Subcutaneous Immunoglobulin 16.5 (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens. J Clin Immunol. 2023; 43(6):1414-1425.

This is an international website for cutaquig® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).

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