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Your search keyword '"Stein, Mark A."' showing total 18 results
Start Over Author "Stein, Mark A." Search Limiters Peer Reviewed Journal journal of clinical immunology
18 results on '"Stein, Mark A."'

1. Response to the Letter to the Editor Regarding "Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials".

Author

Suez, Daniel, Stein, Mark, Gupta, Sudhir, Hussain, Iftikhar, Melamed, Isaac, Paris, Kenneth, Darter, Amy, Bourgeois, Christelle, Fritsch, Sandor, Leibl, Heinz, McCoy, Barbara, Gelmont, David, and Yel, Leman

Subjects
Humans, Immunologic Deficiency Syndromes, Immunoglobulin G, Injections, Subcutaneous, Reference Standards, Clinical Trials, Phase III as Topic, Drug-Related Side Effects and Adverse Reactions, Data Analysis, Good Health and Well Being, Immunology
Published
2017

2. Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America

Author

Suez, Daniel, Stein, Mark, Gupta, Sudhir, Hussain, Iftikhar, Melamed, Isaac, Paris, Kenneth, Darter, Amy, Bourgeois, Christelle, Fritsch, Sandor, Leibl, Heinz, McCoy, Barbara, Gelmont, David, and Yel, Leman

Subjects
Vaccine Related, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Adolescent, Adult, Aged, Aged, 80 and over, Bacterial Infections, Child, Child, Preschool, Female, Humans, Immunoglobulins, Intravenous, Immunologic Deficiency Syndromes, Infusions, Subcutaneous, Male, Middle Aged, Quality of Life, Treatment Outcome, Young Adult, Primary immunodeficiency diseases, Immunoglobulin replacement therapy, Subcutaneous administration, 20% immunoglobulin, Pharmacokinetics, 20 % immunoglobulin, Immunology
Abstract

Patients with primary immunodeficiency disease (PIDD) typically require life-long intravenous (IV) or subcutaneous (SC) immunoglobulin (Ig) replacement therapy to prevent recurrent infections. The efficacy, safety, and pharmacokinetics of a highly concentrated (20 %) Ig preparation for SC administration (IGSC 20 %) were evaluated in a prospective trial in patients with PIDD. A total of 74 patients (aged 3-83 years) received 4327 IGSC 20 % infusions over a median of 380.5 days. The rate of validated serious bacterial infections was 0.012 event/patient-year (p 14.5 g/l. The median maximum infusion rate was 60 ml/h/site (range 4.4-180), resulting in a median infusion duration of 0.95 h. A volume ≥30 ml was infused per site in 74.8 % of IGSC 20 % infusions. Most (84.9 %) infusions were administered using ≤2 infusion sites; for 99.8 % of infusions, there was no need to interrupt/stop administration or reduce the infusion rate. No related serious adverse event (AE) occurred during IGSC 20 % treatment; related non-serious AEs occurred at a rate of 0.036 event/infusion. The incidence of related local AEs was 0.015 event/infusion and of related systemic AEs was 0.021 event/infusion; most were mild in severity, none severe. Increased infusion rates or volumes were not associated with higher AE rates. The investigated IGSC 20 % treatment was shown to be effective and safe, enabling higher infusion rates and volumes per site compared to conventional SC treatments, resulting in fewer infusion sites and shorter infusion durations.

Published
2016

3. Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency.

Author

Wasserman, Richard L, Melamed, Isaac, Stein, Mark R, Engl, Werner, Sharkhawy, Marlies, Leibl, Heinz, Puck, Jennifer, Rubinstein, Arye, Kobrynski, Lisa, Gupta, Sudhir, Grant, Andrew J, Ratnayake, Anoshie, Richmond, Wendell G, Church, Joseph, Yel, Leman, and Gelmont, David

Subjects
Humans, Bacterial Infections, Immunologic Deficiency Syndromes, Hyaluronoglucosaminidase, Immunoglobulins, Intravenous, Recombinant Proteins, Treatment Outcome, Hospitalization, Time Factors, Adolescent, Adult, Aged, Middle Aged, Child, Female, Male, Infusions, Subcutaneous, Young Adult, Subcutaneous IgG replacement, efficacy, primary immunodeficiency, recombinant human hyaluronidase, tolerability, Pediatric, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Immunology
Abstract

PurposeTreatment of primary immunodeficiency diseases (PIDD) with subcutaneous (SC) infusions of IgG preceded by injection of recombinant human hyaluronidase (rHuPH20) (IGHy) to increase SC tissue permeability was evaluated in two consecutive, prospective, non-controlled, multi-center studies.MethodsSubjects >4 years of age received SC IgG replacement at a weekly dose equivalent of 108 % of their previous intravenous (IV) dose, facilitated by prior injection of 75 U/g IgG of rHuPH20. Starting with weekly SC infusions, the interval was increased (ramped-up) to a 3- or 4-week schedule.ResultsEighty-three subjects (24

Published
2016

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