Keywords
Diseases & therapies
Immunology
Octapharma USA Research at AAAAI: cutaquig® Study at Higher Infusion Rates Presented
PARAMUS, NJ
2023-03-06
Press release
Increasing Infusion Volume Per Site Resulted in a Reduction of Injection Sites
Increasing Infusion Rates Decreased Infusion Duration
Octapharma USA presented research at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting evaluating the efficacy and safety of cutaquig® (Immune Globulin Subcutaneous [Human]-hipp, 16.5% solution) infusions at higher infusion parameters, potentially offering greater dosing flexibility for patients.
Subcutaneous immunoglobulin (SCIG) has been an accepted mode of infusion for over 30 years and, with its increased utilization, improvements in methodology now drive replacement therapy in patients with primary immune deficiency. To further explore dosing flexibility with potential reductions in infusion time, sites, and/or frequency, Octapharma conducted a prospective, open-label, multicenter, Phase 3 study (NCT03939533) to evaluate the efficacy and safety of cutaquig® in three modified infusion regimens. Cutaquig® is indicated for treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients age 2 and older.
“From both the patient and physician perspective, the benefits of SCIG include stable serum IgG levels, a reduction in systemic side effects as compared to intravenous immune globulin (IVIG) and improved compliance and reductions in hospitalizations as a result of the flexibility of self-administration,” said Primary Investigator Sudhir Gupta, MD, Chief, Basic and Clinical Immunology, University of California, Irvine, School of Medicine, and Director, Jeffrey Modell Diagnostic Center for Primary Immunodeficiencies. “The research suggests that cutaquig® infusions at higher infusion parameters, may offer greater dosing flexibility for patients.”
Octapharma’s AAAAI poster, entitled Subcutaneous Immunoglobulin 16.5% (cutaquig®) in Primary Immunodeficiency Disease: Safety, Efficacy, and Patient Experience with Modified Infusion Regimens, reports that increasing infusion volume resulted in a reduction of injection sites, while increasing infusion rates subsequently decreased infusion duration. Dosing every other week demonstrated equivalency to trough levels with weekly dosing.
“Octapharma is committed to providing the PI community life-saving and life-enhancing therapies so we were happy to see that the research was well-received by AAAAI attendees,” said Octapharma USA President Flemming Nielsen. "The study evaluated increased infusion volume per site, increased infusion rate, and increased interval between infusions when compared to previous approved regimens for cutaquig® and may offer more flexibility around administration options for patients in the future.”
The cutaquig® study was organized into three cohorts. In cohort 1, the volume per site (maximum 100 mL/site) was increased by reducing the total number of injection sites while maintaining similar flow rates. In cohort 2, the infusion rate per site was increased until reaching a maximum flow rate of 100 mL/hr/site or maximum tolerated flow rate. In cohort 3, patients received double their weekly dose every other week.
The results of the study were as follows:
For cohort 1 (n=15), the maximum realized volume per site was 108 mL/site; 33.3% of patients (5/15) attained ≥90% of the allowed maximum volume of 100 mL/site. The mean number of infusion sites were reduced to 2.3 versus 3.3 and 3.9 in cohorts 2 and 3, respectively.
In cohort 2 (n=15), the maximum realized infusion flow rate was 67.5 mL/hr/site indicating that higher infusion flow rates were well tolerated and reduced the duration of infusion.
In cohort 3 (n=34), the mean total trough levels for every other week dosing demonstrated equivalency to weekly dosing (p value = 0.0017).
No serious bacterial infections were reported.
The AAAAI Annual Meeting was held Feb. 24 – 27. For program details, please visit aaaai.org.
About cutaquig®
Cutaquig® (Immune Globulin Subcutaneous [Human]-hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
CONTRAINDICATIONS
History of anaphylactic or severe systemic reaction to human immune globulin or other components of cutaquig® (Polysorbate 80).
IgA deficient patients with antibodies against IgA and a history of hypersensitivity.
WARNING: THROMBOSIS
Thrombosis may occur with immune globulin products, including cutaquig®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
For patients at risk of thrombosis, administer cutaquig® at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
For complete prescribing information, please visit cutaquigusa.com/pi.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com.