Octapharma Study Presented at CIS Demonstrates cutaquig® Efficacy and Safety
HOBOKEN, N.J.--(BUSINESS WIRE)--May 6, 2019--Octapharma presented clinical research results at the Clinical Immunology Society Annual Meeting in Atlanta demonstrating the efficacy and safety of cutaquig ® (Immune Globulin Subcutaneous (Human) - hipp), a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults.
“Subcutaneously administered immunoglobulin (SCIG) is increasingly used to treat patients with primary immunodeficiencies,” said Octapharma USA President Flemming Nielsen. “In addition to not requiring venous access, SCIG has few systemic side effects and can help improve patient quality of life. The evaluation of adverse events and infusion site reactions during the study showed that subcutaneous administration of cutaquig ® was well tolerated and safe in the assessed patient population.”
The clinical trial’s primary endpoint of preventing serious bacterial infections (SBIs) was met as none of the patients experienced an SBI during the study. Based on historical data, an SBI rate of less than 1.0 per person a year provides substantial evidence of efficacy. 1
The study, entitled “Efficacy, Safety and Tolerability of a Subcutaneous Human Immunoglobulin 16.5% (cutaquig ® ) in Adult Patients with Primary Immune Deficiencies,” further reported a rate of other infections per person a year of 2.73 with 65 percent of the infections being mild and 35 percent moderate in intensity. Eighty-five percent of infusions had no site reactions. 1
“The patients were extremely thankful to be able to use the subcutaneous method of administration with cutaquig ® as this provided a safe method to do the infusions at home avoiding the long and often tedious travel to the hospital for treatment,” said Dr. Elena Latysheva of the National Research Center Institute of Immunology FMBA in Moscow, Russia.
“This study corroborates the pivotal global cutaquig ® trial recently published in Frontiers in Immunology where also none of the patients experienced a serious bacterial infection,” 2 said Dr. Roger H. Kobayashi, UCLA School of Medicine Clinical Professor, Division of Pediatric Allergy and Immunology.
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.
- 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.
Please see full prescribing information for complete boxed warning and other important information here.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs approximately 8,314 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com.
- Data on file, Octapharma USA, 2019.
- Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig®]) in the Treatment of Patients With Primary Immunodeficiencies. Kobayashi RH, Gupta S, Melamed I, Mandujano JF, Kobayashi AL, Ritchie B, Geng B, Atkinson TP, Rehman S, Turpel-Kantor E, Litzman J. Front Immunol. 2019 Feb 4;10:40. doi: 10.3389/fimmu.2019.00040. eCollection 2019.
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KEYWORD: UNITED STATES NORTH AMERICA GEORGIA NEW JERSEY
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL RESEARCH SCIENCE GENERAL HEALTH
SOURCE: Octapharma USA
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PUB: 05/06/2019 10:03 AM/DISC: 05/06/2019 10:03 AM