Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease.
Immune globulins for IgG supplementation have been produced for over 35 years with essentially no differentiating features regarding their specific antibody composition. Furthermore, the compositions of plasma donor pools used for IG manufacturing are not standardized. While all immune globulin products meet the specifications set by the US FDA for antibodies to pathogens like measles and polio, they have variable levels of antibodies to other important viruses and infectious pathogens, particularly respiratory syncytial virus (RSV).



An IVIG was developed that satisfies the requirements for treating patients with primary immune deficiency disease (PIDD) and also has standardized elevated levels of RSV neutralizing antibodies (RI-002). Plasma donors who have naturally occurring high circulating levels of neutralizing anti-RSV antibody were selected as the source for manufacturing IVIG to treat patients with PIDD to prevent serious bacterial infections. While the introduction of the monoclonal antibody Palivizumab has had a dramatic impact in diminishing the burden of RSV disease in the pediatric population, it does not meet the standards for replacing the deficient immune compartments of patients with PIDD.



Fifty-nine patients with PIDD at 9 different sites across the US were enrolled in this study and received regular infusions of RI-002 over the course of 1 year.



There were zero serious bacterial infections, thus meeting the primary endpoint for this trial. The secondary endpoints including days missed from work due to infection, unscheduled visits to the physician, and days of hospitalization due to infection compared favorably to published reports of other IVIG products.
Allergy Partners of North Texas Research, 7777 Forest Lane, Building B, Suite 332, Dallas, TX, 75230, USA. drrichwasserman@gmail.com.
Richard L
RL
Wasserman
Allergy and Asthma Specialists, 10100 North Central Expressway, Suite 100, Dallas, TX, 75231, USA.
William
W
Lumry
The South Bend Clinic, LLP, 211 North Eddy Street, South Bend, IN, 46617, USA.
James
J
Harris
Family Allergy & Asthma Center, PC, 5555 Peachtree Dunwoody Road NE, Atlanta, GA, 30342, USA.
Robyn
R
Levy
Allergy Associates of Palm Beaches, 840 US Highway 1, Suite 250, North Palm Beach, FL, 33408, USA.
Mark
M
Stein
Baylor College of Medicine, Feigin Center, 1102 Bates Street, Suite 330, Houston, TX, 77030, USA.
Lisa
L
Forbes
Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10029, USA.
Charlotte
C
Cunningham-Rundles
Immunoe International Research Centers, 6801 South Yosemite Street, Centennial, CO, 80112, USA.
Isaac
I
Melamed
Midlands Pediatrics, P.C., 401 East Goldcoast Road, Suite 325, Papillion, NE, 68046, USA.
Ai Lan
AL
Kobayashi
Clinical Statistics Consulting, 110 Chatsworth Court, Blue Bell, PA, 19422, USA.
Wei
W
Du
UCLA, School of Medicine, 10833 Le Conte Avenue, Los Angeles, CA, 90095, USA.
Roger
R
Kobayashi
D000293:Adolescent; D000328:Adult; D000368:Aged; D057134:Antibodies, Neutralizing / Q000008:administration & dosage; D000914:Antibodies, Viral / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000494:pharmacology* / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018357:Respiratory Syncytial Virus Infections / Q000209:etiology / Q000517:prevention & control; D012136:Respiratory Syncytial Viruses / Q000276:immunology; D016896:Treatment Outcome; D055815:Young Adult
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D016756:Immunoglobulins, Intravenous
Intravenous immunoglobulin (IVIG); clinical trial; efficacy; pharmacokinetics; primary immunodeficiency (PIDD); safety