DEERFIELD, Ill., October 30, 2014 - Baxter International Inc. (NYSE:BAX) presented the results of a Phase 2/3 study of its investigational 20 percent concentration subcutaneous immunoglobulin treatment for primary immunodeficiencies (PI) during the biennial congress of the European Society for Immunodeficiencies, held in Prague.
Immunoglobulin (IG) treatment for patients with primary immunodeficiency typically requires intravenous (IV) infusions every three to four weeks or conventional subcutaneous (SC) infusions weekly or bi-weekly. Conventional subcutaneous IG treatment is associated with fewer systemic adverse events compared with IV, but requires multiple injection sites per infusion given decreased bioavailability and the need for increased volume to achieve efficacy goals.
The Phase 2/3 study evaluated the efficacy, safety, tolerability and pharmacokinetics (PK) of IGSC 20 percent in European patients at least two years old with PI. A total of 48 study participants received IGSC 16 percent or IVIG 10 percent for three months, followed by weekly doses of IGSC 20 percent for up to 12 months (median of two sites per infusion). The study met its primary endpoint that measured the rate of validated acute serious bacterial infections, or VASBIs. A single event was reported during treatment with IGSC 20 percent (pneumonia of moderate severity), which equated to a low VASBI rate of 0.022/patient-year compared with the specified threshold of one VASBI/patient-year (P<0.0001). The rate of infections with IGSC 20 percent (without dose adjustment) was 4.38/patient-year and mean serum IgG trough levels were comparable to IGIV 10 percent.
There were no serious adverse events (AEs) related to IG treatment. The rate of local AEs considered related to IGSC 20 percent treatment was 0.052/infusion (17 of 48 patients). The majority of local AEs were mild in severity and the most common events were erythema, swelling, pruritus, and pain/discomfort. There were no reports of severe local or systemic AEs related to treatment. Importantly, nearly all infusions (99.8%) were completed without any interruption, slowing, or stopping the infusion.
"We are encouraged by the outcomes of this study, which support our continued efforts to enhance and expand our immunology portfolio to address unmet needs across patient communities," said John Orloff, MD, vice president and global head of research and development for Baxter BioScience. "Once the global studies have been completed, this data set will form the basis for regulatory submissions in the U.S. and Europe as we hope this will offer a new therapeutic alternative for patients with immune deficiency disorders around the world."
Results from a separate study of IGSC 20 percent among PI patients in North America are expected to be available next year.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning Baxter's IGSC 20 percent treatment and related clinical studies, including expectations with regard to regulatory filings and the potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality or supply or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.