Title: Study Shows No Adverse Reactions to Increased Infusion Rate of IVIG Treatment
Study results presented in December at the annual meeting of the American Society of Hematology (ASH) in San Diego, Calif., showed no increase in adverse events associated with an increased maximum infusion rate of Gamunex®, Bayer BP's advanced immune globulin intravenous (IGIV), in patients with immune thrombocytopenic purpura (ITP).
Gamunex is a therapy that contains antibodies purified from the donated blood plasma of thousands of people. It is used to treat a variety of health problems and can be used for either immune replacement or immune modulation. In ITP, Gamunex acts as an immune modulator, regulating the platelet count.
The study, entitled “Intravenous Immunoglobin Manufactured Using a Novel Caprylate and Chromatography-Based Method (IGIV-Gamunex) Was Safe and Well Tolerated When Administered at an Increased Maximum Rate in Patients with Idiopathic Thrombocytopenic Purpura (ITP),” observed that, based on a dose of 1 g/kg for a 70 kg patient, a faster infusion rate resulted in an average time saving of nearly 50 minutes per infusion, approximately one-third of the total infusion time compared to the currently approved maximum infusion rate. The incidence of infusion-related adverse events was similar for both the currently approved maximum rate and the higher rate evaluated in this study. The time saved with the more rapid rate of infusion may enhance patient compliance, limit loss of time from work or school, and reduce medical and nursing costs.
"We are encouraged by the tolerability of Gamunex, even at higher infusion rates, which we observed in this small clinical trial," said the study's principal investigator James Bussel, M.D., professor of pediatrics with secondary appointments in OBGYN and Medicine, New York Presbyterian Hospital. "The time savings with the more rapid rate of infusion may be a benefit to patients, as well as providing greater efficiency, and thereby cost savings, i.e., reduced need for doctor or nurse time."
ITP patients in the United States were studied to determine the safety and tolerability of Gamunex at a higher infusion rate in a randomized, single center, open label, cross-over study. By studying Gamunex at the FDA-approved infusion rate of 0.08 mL/kg/min (or 4.8 mL/kg/hour) compared to a more rapid rate of 0.14 mL/kg/min (or 8.4 mL/kg/hour), the study center could determine if the frequency and severity of adverse events increased with a faster infusion rate.
Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, was administered at a dose of 1.0 g/kg to each patient in the study on two occasions as a single-daily infusion over a maximum interval of six weeks. Patients were randomized into two groups, with one group receiving Gamunex at the standard maximum rate and the other receiving the higher rate in the first infusion. In the second infusion, each group received infusions at the opposite rate. A total of eight patients received the standard infusion rate, and seven patients received the faster infusion rate. No steroid pre- medication was permitted for either infusion rate.
Clinical Endpoints and Key Findings
Results demonstrated that the incidence of infusion-related adverse events was similar for both infusion rates. None of the treatment-emergent events were severe for either infusion rate; 84 percent of the events observed in this study were designated as mild in nature, with the most commonly reported adverse event being a headache. The higher infusion rate demonstrated an average time saving of 48.4 minutes, or approximately one-third of the infusion time compared to the current approved maximum infusion rate, with a mean duration of 97.86 plus/minus 6.36 minutes for the faster infusion rate, compared with 146.25 plus/minus 5.82 for the standard rate.
The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain.