Journal of Clinical Immunology Publishes Octapharma USA Research on cutaquig® Evaluating PI Treatment Options

• The research suggests that cutaquig^® infusions at higher infusion parameters, may offer greater dosing flexibility for primary immunodeficiency patients

• The majority of patients in the study found the new investigational infusion regimens to be better or somewhat better than their previous regimens

• Study evaluated increased infusion volume per site, infusion rate, and interval between infusions

• The study results were presented to attendees at the Clinical Immunology Society 2023 Annual Meeting on May 18-21

An Octapharma-sponsored study published recently in The Journal of Clinical Immunology concludes that cutaquig^® (Immune Globulin Subcutaneous [Human]-hipp, 16.5% solution) infusions at higher infusion rates, volume and therapy intervals met study endpoints for efficacy and safety, and were generally well tolerated with reduced infusion time, fewer infusion sites, and reduced frequency. The journal further reported the majority of study patients found the new investigational infusion regimens to be better or somewhat better than their previous regimens.

“The research suggests that cutaquig^® infusions at higher infusion parameters, may offer greater dosing flexibility for patients,” 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. “From both the patient and physician perspective, the benefits of subcutaneous immunoglobulin (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.”

Cutaquig^® is indicated for treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients aged 2 and older.

“We are hopeful that higher infusion rates may provide patients with more flexibility and time to focus on their lives,” said Octapharma USA President Flemming Nielsen. "Octapharma is committed to providing the PI community with life-saving and life-enhancing therapies. The study fit that mission perfectly by evaluating increased infusion volume per site, increased infusion rate, and increased interval between infusions when compared to previous approved regimens for cutaquig^®.”

The increased utilization of SCIG and improvements in methodology now drive replacement therapy in patients with primary immune deficiency. Octapharma sponsored the Phase 3 study (NCT03939533) to further explore dosing flexibility with potential reductions in infusion time, sites, and/or frequency. The study results were presented to attendees at the Clinical Immunology Society 2023 Annual Meeting on May 18-21 in St. Louis, Missouri.

The clinical trial evaluated the efficacy and safety of cutaquig^® in three modified infusion regimens. Researchers observed 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.

In three separate cohorts, patients received cutaquig^® with researchers evaluating volume, rate, and frequency. For cohort one (n = 15), the maximum realized volume per site was 108 mL/site, exceeding the currently labeled (US) maximum (up to 40 mL/site for adults). In cohort two (n = 15), the maximum realized infusion flow rate was 67.5 mL/hr/site, which is also higher than the labeled (US) maximum (up to 52 mL/hr/site). In cohort three (n = 34), the mean total trough levels for every other week dosing demonstrated equivalency to weekly dosing (p value = 0.0017).

“All regimens were well tolerated,” the journal article noted. “There were no serious bacterial infections. Most patients had mild (23.4%) or moderate (56.3%) adverse events. The majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens and reported that switching to cutaquig^®  was easy.”¹

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.

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.

Reference

1 - Gupta S, DeAngelo J, Melamed I, Walter JE, Kobayashi AL, Bridges T, Sublett JW, Bernstein JA, Koterba A, Manning M, Maltese J, Hoeller S, Turpel-Kantor E, Kreuwel H, Kobayashi RH. Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens. J Clin Immunol. 2023 May 9. doi: 10.1007/s10875-023-01509-4. Epub ahead of print. PMID: 37160610.

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