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Journal of Clinical Immunology

Erschienen in:

Open Access 10.07.2017 | Letter to Editor

Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials

verfasst von: Mark Ballow, Richard L. Wasserman, Stephen Jolles, Helen Chapel, Mel Berger, Siraj A. Misbah

Erschienen in: Journal of Clinical Immunology | Ausgabe 6/2017

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To the editor: …

Suez D, Stein M, Gupta S, Hussain I, Melamed I, Paris K, et al. Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36:700–12. CrossRef

Datta R, Kuruvilla M, Gill M, de la Morena MT. Association of skin necrosis with subcutaneous immunoglobulin therapy. Ann Allergy Immunol. 2014;113:232–3. CrossRef

Borte M, Kriván G, Derfalvi B, Maródi L, Harrer T, et al. Efficacy, safety, tolerability and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a phase 2/3 study in Europe in patients with primary immunodeficiencies. Clin Exp Immunol 2016. doi: 10.1111/cei.12866. [Epub ahead of print]. CrossRef

Jolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, et al. Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011;141:90–102. CrossRef

Hagan JB, Fasano MB, Spector S, Wasserman RL, Melamed I, Rojavin MA, et al. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010;30:734–45. CrossRef

Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, et al. Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clin Immunol. 2013;150:161–9. CrossRef

U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency. 2008.

European Agency for the Evaluation of Medicinal Products, Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use (CPMP/BPWG/283/00), 2002.

Titel: Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials
verfasst von: Mark Ballow
Richard L. Wasserman
Stephen Jolles
Helen Chapel
Mel Berger
Siraj A. Misbah
Publikationsdatum: 10.07.2017
Verlag: Springer US
Erschienen in: Journal of Clinical Immunology / Ausgabe 6/2017
Print ISSN: 0271-9142
Elektronische ISSN: 1573-2592
DOI: https://doi.org/10.1007/s10875-017-0410-x

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Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials

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