10 results on '"Wasserman RL"'
Search Results
2. Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases.
- Author
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Wasserman RL, Gupta S, Stein M, Rabbat CJ, Engl W, Leibl H, and Yel L
- Subjects
- Adolescent, Child, Child, Preschool, Comorbidity, Female, Humans, Immunoglobulins administration & dosage, Infusions, Subcutaneous, Male, Primary Immunodeficiency Diseases immunology, Retrospective Studies, Treatment Outcome, Bacterial Infections epidemiology, Immunization, Passive methods, Immunoglobulins therapeutic use, Primary Immunodeficiency Diseases drug therapy, Primary Immunodeficiency Diseases epidemiology
- Abstract
Aim: This post hoc analysis evaluated the efficacy and overall tolerability of immunoglobulin (Ig) treatment modalities (intravenous Ig [iv.Ig], subcutaneous Ig [sc.Ig] and facilitated sc.Ig [fsc.Ig]). Materials & methods: A total of 30 participants with primary immunodeficiency diseases aged ≥2 years sequentially received iv.Ig, sc.Ig and fsc.Ig during consecutive clinical studies. Results: For iv.Ig, sc.Ig and fsc.Ig, rates of validated acute serious bacterial infections/participant-year (0, 0.09 and 0.04, respectively) and all infections/participant year (4.17, 3.68 and 2.42, respectively) were similarly low; rates of systemic and local causally related adverse events/participant-year were 5.60, 1.93 and 0.88, respectively and 0.13, 0.92 and 1.57, respectively. Conclusion: fsc.Ig provided similar efficacy to iv.Ig and sc.Ig. Clinical Trial registration: NCT00546871, NCT00814320, NCT01175213 (ClinicalTrials.gov).
- Published
- 2022
- Full Text
- View/download PDF
3. Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin infusion in primary immunodeficiency diseases.
- Author
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Wasserman RL
- Subjects
- Animals, Humans, Hyaluronoglucosaminidase genetics, Immunologic Deficiency Syndromes immunology, Infusions, Subcutaneous, Practice Guidelines as Topic, Recombinant Proteins genetics, Hyaluronoglucosaminidase metabolism, Immunoglobulins therapeutic use, Immunologic Deficiency Syndromes therapy, Immunotherapy methods, Recombinant Proteins metabolism
- Abstract
Most primary immunodeficiency diseases (PIDDs) resulting in antibody deficiency require intravenous or subcutaneous immunoglobulin G (SCIG) replacement therapy. The flow and distribution of SCIG to the vasculature is impeded by the glycosaminoglycan hyaluronan in the extracellular matrix, which limits the infusion rate and volume per site, necessitating frequent infusions and multiple infusion sites. Hyaluronidase depolymerizes hyaluronan and is a spreading factor for injectable biologics. Recombinant human hyaluronidase (rHuPH20) increases SCIG absorption and dispersion. In patients with PIDD, SCIG facilitated with rHuPH20 (IGHy) has been shown to prevent infections, be well-tolerated and reduce infusion frequency and number of infusion sites as compared with conventional SCIG. This article reviews IGHy clinical studies and real-world practice data in patients with PIDD.
- Published
- 2017
- Full Text
- View/download PDF
4. The Nuts and Bolts of Immunoglobulin Treatment for Antibody Deficiency.
- Author
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Wasserman RL
- Subjects
- Animals, Antigens, Neoplasm immunology, Drug Monitoring, Histone Acetyltransferases immunology, Humans, Hyaluronoglucosaminidase immunology, Immunoglobulins administration & dosage, Immunoglobulins adverse effects, Insurance Benefits, Insurance, Health, Immunoglobulins therapeutic use, Immunologic Deficiency Syndromes drug therapy
- Abstract
Immunoglobulin therapy is a key element in the management of most patients with primary immunodeficiency disease. Allergist/immunologists should be familiar with the appropriate evaluation of candidates for immunoglobulin, the characteristics of immunoglobulin products, and how to use them to provide the best care to their patients. Available immunoglobulin products appear to be equally efficacious, but they are not interchangeable. Minimizing the risk of serious adverse events and controlling minor side effects is important to ideal patient care. Immunoglobulin may be administered intravenously or subcutaneously. Individualizing the choice of immunoglobulin product, mode of administration, and site of care can optimize the clinical outcome and minimize the burden of care., (Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
- Full Text
- View/download PDF
5. Recombinant human hyaluronidase facilitated subcutaneous immunoglobulin treatment in pediatric patients with primary immunodeficiencies: long-term efficacy, safety and tolerability.
- Author
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Wasserman RL, Melamed I, Kobrynski L, Puck J, Gupta S, Doralt J, Sharkhawy M, Engl W, Leibl H, Gelmont D, and Yel L
- Subjects
- Adolescent, Antigens, Neoplasm adverse effects, Antigens, Neoplasm genetics, Child, Child, Preschool, Female, Histone Acetyltransferases adverse effects, Histone Acetyltransferases genetics, Humans, Hyaluronoglucosaminidase adverse effects, Hyaluronoglucosaminidase genetics, Immunologic Deficiency Syndromes immunology, Injections, Subcutaneous, Male, Recombinant Proteins genetics, Time Factors, United States, Antigens, Neoplasm therapeutic use, Histone Acetyltransferases therapeutic use, Hyaluronoglucosaminidase therapeutic use, Immunoglobulins therapeutic use, Immunologic Deficiency Syndromes therapy
- Abstract
Aim: To assess the long-term efficacy, safety and tolerability of recombinant human hyaluronidase-facilitated subcutaneous infusion of immunoglobulin (Ig) (fSCIG; HYQVIA(®); IGHy) in children aged <18 years., Patients & Methods: Patients with primary immunodeficiency diseases were included in the studies. IGHy was administered every 3 or 4 weeks., Results: Validated acute serious bacterial infections were reported at 0.08/patient-year (four pneumonia episodes in three patients). No serious adverse drug reaction (ADR) was reported, and rates of local and systemic ADRs were low (0.09/infusion and 0.1/infusion). Infection rates were low (3.02/patient-year) with sustained Ig trough levels (median: 1009 mg/dl). Of 674 IGHy infusions, 97.2% required no change of administration due to ADR, in most (82.5%) with one infusion site. No patient developed neutralizing anti-rHuPH20 antibodies. Postpivotal study, 100% of patients aged <14 years or their caregivers and 85.7% of patients aged 14 to <18 years expressed preference for IGHy compared with Ig administered intravenously or Ig administered subcutaneously., Conclusion: These studies, with the longest (maximum: 3.3 years) duration of any reported Ig replacement trials in children with primary immunodeficiency diseases, showed low infection, local and systemic reaction rates along with well-tolerated infusions given in a single site.
- Published
- 2016
- Full Text
- View/download PDF
6. 20% subcutaneous immunoglobulin dosed biweekly for primary immunodeficiency.
- Author
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Wasserman RL, Stein MR, Younger ME, Fatteh S, and Haddad E
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Drug Approval, Female, Humans, Immunologic Deficiency Syndromes immunology, Injections, Subcutaneous, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Young Adult, Immunoglobulins therapeutic use, Immunologic Deficiency Syndromes therapy, Immunotherapy methods
- Published
- 2016
- Full Text
- View/download PDF
7. Subcutaneous immunoglobulin: facilitated infusion and advances in administration.
- Author
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Wasserman RL
- Subjects
- Clinical Trials, Phase III as Topic, Humans, Immunoglobulins, Intravenous administration & dosage, Immunoglobulins, Intravenous adverse effects, Prospective Studies, Immunization, Passive adverse effects, Immunoglobulins administration & dosage, Immunoglobulins adverse effects, Infusions, Subcutaneous adverse effects
- Published
- 2014
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8. A new intravenous immunoglobulin (BIVIGAM®) for primary humoral immunodeficiency.
- Author
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Wasserman RL
- Subjects
- Clinical Trials as Topic, Humans, Immunologic Deficiency Syndromes complications, Immunologic Deficiency Syndromes immunology, Infections etiology, Immunity, Humoral drug effects, Immunity, Humoral genetics, Immunoglobulins deficiency, Immunoglobulins, Intravenous therapeutic use, Immunologic Deficiency Syndromes therapy, Infection Control methods
- Abstract
Human immunoglobulin G administered intravenously or subcutaneously is used to prevent infections in patients with primary antibody deficiencies. Intravenous immunoglobulin (IVIG) preparations have improved over the years and have evolved from immune serum globulin that is injected intramuscularly or subcutaneously at relatively low doses (100-150 mg/kg per month). IVIG products are currently available in different concentrations and compositions and can deliver up to 2 g/kg or more per infusion with few side effects. This report describes the properties and clinical trial results of BIVIGAM(®), a new IVIG product. We also discuss how improvements in intravenous immunoglobulin manufacturing and formulation have improved clinical outcomes in patients with primary immunodeficiencies, also benefiting patients with other immunological disorders.
- Published
- 2014
- Full Text
- View/download PDF
9. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency.
- Author
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Wasserman RL, Melamed I, Stein MR, Gupta S, Puck J, Engl W, Leibl H, McCoy B, Empson VG, Gelmont D, and Schiff RI
- Subjects
- Adolescent, Adult, Aged, Child, Child, Preschool, Humans, Immunoglobulins adverse effects, Infusions, Subcutaneous, Middle Aged, Prospective Studies, Recombinant Proteins administration & dosage, Hyaluronoglucosaminidase administration & dosage, Immunoglobulins administration & dosage, Immunologic Deficiency Syndromes drug therapy
- Abstract
Background: Subcutaneous immunoglobulin (IGSC) replacement therapy for primary immunodeficiency (PI) is equally efficacious to intravenous immunoglobulin (IGIV), induces fewer systemic reactions, and may be self-infused. Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. Recombinant human hyaluronidase (rHuPH20) increases SC tissue permeability and facilitates dispersion and absorption, enabling administration of monthly doses in one site., Objective: This study investigated the efficacy and tolerability of rHuPH20-facilitated IGSC (IGHy) in patients with PI., Methods: In this open-label, multicenter phase III study, 87 patients with PI aged ≥2 years received 10% IGIV for 3 months, then IGHy (n = 83) for approximately 14 to 18 months at 108% of the IGIV dose. IGHy infusions began weekly, increasing to 3- or 4-week intervals., Results: The majority (94.0%) of IGHy infusions were administered every 3 or 4 weeks, using one site (median, 1.09/month), with a mean volume of 292.2 mL. The bioavailability of IGHy measured by area under the concentration versus time curve was 93.3% of IGIV, which is pharmacokinetically equivalent. Systemic reactions were less frequent with IGHy than with IGIV (8.3% vs 25.0% of infusions). Local reactions to IGHy were generally mild to moderate, with a rate of 0.203 per infusion. The acute serious bacterial infection rate per subject-year for IGHy was low (0.025; upper 99% CI limit, 0.046). Overall infection rates per subject-year were 2.97 for IGHy and 4.51 for IGIV., Conclusion: IGHy was effective, safe, and pharmacokinetically equivalent to IGIV at the same administration intervals, but it caused fewer systemic reactions. Tolerability was good despite high infusion volumes and rates., (Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.)
- Published
- 2012
- Full Text
- View/download PDF
10. Use of Epstein-Barr virus-transformed B cell lines for the generation of immunoglobulin-producing human B cell hybridomas.
- Author
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Chiorazzi N, Wasserman RL, and Kunkel HG
- Subjects
- B-Lymphocytes microbiology, Cell Fusion, Cell Line, Humans, Lymphocyte Activation, Tetanus Toxoid immunology, B-Lymphocytes immunology, Cell Transformation, Viral, Herpesvirus 4, Human physiology, Hybridomas immunology, Immunoglobulins biosynthesis
- Abstract
HGPRTase-deficient EBV-transformed B cell lines were shown to be effective fusion partners with mitogen-activated human B cells for the construction of Ig-producing human B cell hybridomas. In a series of experiments using these lines and B cells from several tissue sources, approximatley 20% of the cultures plated were consistently positive for growth after hypoxanthine-aminopterin-thymidine selection and approximatley 30% of these synthesized significant new Ig. A marked increase in Ig secretion was observed after hybridization, which was due to new Ig; Ig from the parental lime was shown to disappear in several instances. Special analyses were carried out on a human hybridoma secreting antibody specific for tetanus toxoid and tetanus toxin and stable subclones were derived. These studies suggest that EBV-transformed lines will prove useful in human hybridization studies, thus making a large library of B cell lines available for the generation of human monoclonal antibodies.
- Published
- 1982
- Full Text
- View/download PDF
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