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Efficacy

Proven Efficacy

Patients can have confidence in cutaquig®’s demonstrated efficacy.

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Patients can have confidence in cutaquig®’s demonstrated efficacy

*Serious bacterial infections included bacterial pneumonia, bacteremia/sepsis, osteomyelitis/septic arthritis, visceral abscess and bacterial meningitis. Infections Zero serious bacterial infections* in three clinical trials. One SBI not related to cutaquig® in the extension study ¹⁻⁵ Other infections were seen at a rate of 2.1 to 3.3 per person-year ¹⁻⁵ Antibiotics Immunoglobulin replacement therapy has been demonstrated to reduce the frequency of severe infections and theuse of antibiotics ¹⁻⁵ Fever, hospitalisation and absences from school/work Further confirmation of the efficacy of cutaquig® was demonstrated by low episodes of fever, hospitalisations and absences from school/work ¹⁻⁵
Infections Zero serious bacterial infections* in three clinical trials. One SBI not related to cutaquig® in the extension study ¹⁻⁵ Other infections were seen at a rate of 2.1 to 3.3 per person-year ¹⁻⁵ Antibiotics Immunoglobulin replacement therapy has been demonstrated to reduce the frequency of severe infections and theuse of antibiotics ¹⁻⁵ Fever, hospitalisation and absences from school/work Further confirmatıon of the efficacy of cutaquig® was demonstrated by low episodes of fever, hospitalisations and absences from school/work ¹⁻⁵ *Serious bacterial infections included bacterial pneumonia, bacteremia/sepsis, osteomyelitis/septic arthritis, visceral abscess and bacterial meningitis.

Proven efficacy in preventing serious bacterial infections1-6

⁶ EMA threshold for
 efficacy of prevention Serious bacterial infection 
 rate per person-year ¹⁻⁵ Phase 3 studies demonstrated a SBI rate between 0 and 0.02 0 1.0
Serious bacterial infection rate per person-year 1 0 EMA threshold for
 efficacy of prevention ⁶ Phase 3 studies demonstrated a SBI rate between 0 and 0.02 ¹⁻⁵

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

  3. 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.

  4. 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.

  5. 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.

  6. EMA. Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg). 2015; Accessed on 11.03.2024. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-human-normal-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).

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