Affiliation: CSL Behring GmbH
- Pharmacokinetics of subcutaneous immunoglobulin and their use in dosing of replacement therapy in patients with primary immunodeficienciesMelvin Berger
Immunology Research and Development, CSL Behring, King of Prussia, PA 19406 0901, USA
Clin Immunol 139:133-41. 2011..When switching a patient from IVIG to SCIG, individualizing the dosage based on measured serum IgG levels and the clinical response is preferable to using mean pharmacokinetic parameters...
- Improved quality of life, immunoglobulin G levels, and infection rates in patients with primary immunodeficiency diseases during self-treatment with subcutaneous immunoglobulin GMelvin Berger
Medical Affairs Department CSL Behring, King of Prussia, PA, USA
South Med J 103:856-63. 2010..We evaluated the long-term (12-month) experience with home-based self infusions of subcutaneous immune globulin (SCIG) in patients with PIDD on health-related QoL, rates of serious bacterial infections, and all other infections...
- Incidence of Infection is Inversely Related to Steady-State (Trough) Serum IgG Level in Studies of Subcutaneous IgG in PIDDMelvin Berger
CSL Behring LLC, 1020 First Ave, King of Prussia, PA, 19406, USA
J Clin Immunol 31:924-6. 2011..Maintaining higher IgG levels may be beneficial, and no given level is necessarily adequate for all patients...
- Adverse effects of IgG therapyMelvin Berger
Immunology Research and Development, CSL Behring, LLC, King of Prussia, PA Electronic address
J Allergy Clin Immunol Pract 1:558-66. 2013..Subcutaneous IgG is absorbed more slowly into the circulation and has a lower incidence of AEs, but awareness and diligence are necessary whenever IgG is administered. ..
- Subcutaneous IgG in neurologic diseasesMelvin Berger
Immunology Research and Development, CSL Behring, LLC, 1020 First Avenue, King of Prussia, PA 19406, USA and Pediatrics and Pathology, Case Western Reserve University, Cleveland, OH, USA
Immunotherapy 6:71-83. 2014..Long-term studies are needed to determine if the constant IgG levels and clinical stability translate into better long-term outcomes. ..
- Bioavailability of IgG administered by the subcutaneous routeMelvin Berger
CSL Behring LLC, King of Prussia, PA 19406, USA
J Clin Immunol 33:984-90. 2013..The results are interpreted as showing that different SCIGs differ in bioavailability. We used three approaches to determine if the bioavailabilities were actually different...
- Immunologic challenges in small bowel transplantationM Berger
Immunology R and D, CSL Behring, LLC, King of Prussia, PA, USA
Am J Transplant 12:S2-8. 2012..Monitoring antidonor antibody production and the use of new therapies including complement inhibitors will contribute to increasing success of SBT...
- L-proline-stabilized human IgG: Privigen® 10% for intravenous use and Hizentra® 20% for subcutaneous useMelvin Berger
Immunology R and D, CSL Behring LLC, 1020 First Ave, PO Box 61501, King of Prussia, PA 19406 0901, USA
Immunotherapy 3:163-76. 2011..These improvements, which translate into improved convenience for pharmacies and patients, were achieved with no compromise in safety, efficacy or tolerability of the products...
- Choices in IgG replacement therapy for primary immune deficiency diseases: subcutaneous IgG vs. intravenous IgG and selecting an optimal doseMelvin Berger
Immunology Research and Development, CSL Behring LLC, King of Prussia, Pennsylvania, USA
Curr Opin Allergy Clin Immunol 11:532-8. 2011....
- Efficacy, pharmacokinetics, safety, and tolerability of Flebogamma 10% DIF, a high-purity human intravenous immunoglobulin, in primary immunodeficiencyMelvin Berger
Case Western Reserve University, Cleveland, OH, USA
J Clin Immunol 30:321-9. 2010..Pathogen safety is enhanced by the combination of multiple methods with different mechanisms of action...
- Use of intravenous immunoglobulin and adjunctive therapies in the treatment of primary immunodeficiencies: A working group report of and study by the Primary Immunodeficiency Committee of the American Academy of Allergy Asthma and ImmunologyPierre L Yong
Robert Wood Johnson Clinical Scholars Program, University of Pennsylvania, Philadelphia, PA, USA
Clin Immunol 135:255-63. 2010..Thus, a need for expanded clinical research in PIDD to optimize management and potentially improve outcomes was defined...
- Subcutaneous administration of IgGMelvin Berger
Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA
Immunol Allergy Clin North Am 28:779-802, viii. 2008..The coming years will see increased use of subcutaneous immunoglobulin in PIDD, which will be facilitated by advances leading to higher-concentration IgG products and easier delivery...
- Principles of and advances in immunoglobulin replacement therapy for primary immunodeficiencyMelvin Berger
Division of Pediatric Allergy and Immunology, Case Western Reserve University, University Hospitals of Cleveland Rainbow Babies and Children s Hospital, 11100 Euclid Avenue, MS RBC 6008B, Cleveland, OH 44106, USA
Immunol Allergy Clin North Am 28:413-37, x. 2008..Continued vigilance is required, however, because problems with emerging diseases, and the costs and availability of ISG are likely to present continuing challenges...
- Safety, efficacy, and pharmacokinetics of Flebogamma 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseasesMelvin Berger
Department of Pathology, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, Ohio 44116, USA
J Clin Immunol 24:389-96. 2004....
- Variability in intravenous immunoglobulin G regimens for autoimmune neuromuscular disordersRandy Broyles
National Director, Operations, BioRx, Cincinnati, OH, USA
Postgrad Med 125:65-72. 2013....
- Subcutaneous immunoglobulin replacement in primary immunodeficienciesMelvin Berger
School of Medicine, Case Western Reserve University, OH, USA
Clin Immunol 112:1-7. 2004..Obstacles may be encountered because no preparation of IgG is currently licensed for subcutaneous use in the US. Subcutaneous IgG replacement may be preferable to i.v. infusions or i.m. injections for carefully selected patients...
- Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseasesMelvin Berger
Rainbow Babies and Children s Hospital, Division of Allergy Immunology, 111100 Euclid Avenue, Cleveland, Ohio 44106, USA
J Clin Immunol 27:503-9. 2007..Serum IgG trough levels were unchanged from baseline. Carimune NF Liquid, a ready-to-use, high-concentration, liquid immunoglobulin preparation is safe and effective...
- A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in primary immunodeficiency diseases (PID) patients of Flebogamma 5% DIF, the next generation of FlebogammaMelvin Berger
Case Western Reserve University, Cleveland, OH, USA
J Clin Immunol 27:628-33. 2007..Flebogamma 5% dual inactivation and filtration (DIF) is the next generation of Flebogamma. Flebogamma was first licensed in 1992. The new preparation features additional viral inactivation and removal steps to enhance safety margins...
- Assessment of protein antibody response in patients with suspected immune deficiencyAkhilesh K Chouksey
Division of Allergy and Immunology, Rainbow Babies and Children s Hospital, Cleveland, Ohio, USA
Ann Allergy Asthma Immunol 100:166-8. 2008
- The response to intravenous immunoglobulin replacement therapy in patients with asthma with specific antibody deficiencyHoward J Schwartz
Department of Pediatrics, Rainbow Babies and Children s Hospital and University Hospitals of Cleveland, Cleveland, Ohio 44106, USA
Allergy Asthma Proc 27:53-8. 2006..We believe that, in this group of patients, the use of intravenous immunoglobulin perhaps allows the achievement of asthma prevention rather than an amelioration of inflammation...
- Chronic inflammation in the cystic fibrosis lung: alterations in inter- and intracellular signalingDavid Nichols
Pulmonology and Allergy Immunology Divisions, Department of Pediatrics, Case Western Reserve University School of Medicine, Rainbow, Babies and Children s Hospital, Cleveland, OH 44106, USA
Clin Rev Allergy Immunol 34:146-62. 2008..Together, these effects combine to create a chronic inflammatory process, which damages and obstructs the airways, and eventually claims the life of the patient...
- A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodiesMelvin Berger
University Hospitals of Cleveland Rainbow Babies and Children s Hospital, Department of Allergy, Immunology, and Rheumatology, 11100 Euclid Avenue, Cleveland, OH 44106, USA
Curr Allergy Asthma Rep 2:368-78. 2002..Those uses continue to expand even as monoclonal antibodies are being introduced for specific infectious diseases in high-risk populations...