Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies

Kenneth Paris; Elie Haddad; Michael Borte; Nicholas Brodszki; Beáta Dérfalvi; Laszlo Maródi; Iftikhar Hussain; Amy Darter; Werner Engl; Heinz Leibl; Barbara McCoy; Leman Yel

doi:10.2217/imt-2018-0088

Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies

Immunotherapy. 2019 Apr;11(5):397-406. doi: 10.2217/imt-2018-0088. Epub 2019 Jan 9.

Authors

Kenneth Paris¹, Elie Haddad², Michael Borte³, Nicholas Brodszki⁴, Beáta Dérfalvi⁵, Laszlo Maródi⁶, Iftikhar Hussain⁷, Amy Darter⁸, Werner Engl⁹, Heinz Leibl⁹, Barbara McCoy⁹, Leman Yel^{10

11}

Affiliations

¹ LSU Health Sciences Center, Children's Hospital of New Orleans, New Orleans, LA 70118, USA.
² Department of Pediatrics, Department of Microbiology, Infectious Diseases & Immunology, University of Montreal, CHU Sainte-Justine, 3175 Ch de la Côte-Sainte-Catherine, Montreal, QC H3T 1C5 Quebec, Canada.
³ Department of Pediatrics, Hospital St. Georg Leipzig, ImmunoDeficiency Center Leipzig, Delitzscher Strasse 141, Leipzig, D - 04129, Germany.
⁴ Department of Pediatric Immunology, Skåne University Hospital, Lasarettsgatan 48, Lund, 22185, Sweden.
⁵ 2nd Department of Pediatrics, Semmelweis University, Tuzolto u. 7, Budapest 1094, Hungary.
⁶ Rockefeller University, 1230 York Ave, New York, NY 10065, USA (at the time of the study: PID Clinical Unit & Laboratory, Department of Dermatology, Venerology & Dermatooncology, Semmelweis University, Budapest, Hungary).
⁷ Department of Allergy and Immunology, Allergy, Asthma, & Immunology Center, 7307 S Yale Ave, Suite 200, Tulsa, OK, 74136, USA.
⁸ Allergy, Immunology, and Asthma, Oklahoma Institute of Allergy & Asthma Clinical Research, 1810 E Memorial Rd, Oklahoma City, OK 73131, USA.
⁹ Shire, Vienna DC-Tower 1, Donau-City-Straße 7, Vienna, 1220, Austria.
¹⁰ Shire, 650 E Kendall St, Cambridge, MA, 02142, USA.
¹¹ Division of Basic & Clinical Immunology, University of California at Irvine, 1001 Health Sciences Rd, Irvine, CA 92697, USA.

PMID: 30626238
DOI: 10.2217/imt-2018-0088

Abstract

Aim: To assess Ig20Gly tolerability in pediatric patients with primary immunodeficiencies.

Patients & methods: Infusion parameters and tolerability were analyzed in pediatric patients (aged 2-5 years [n = 6], 6-11 years [n = 22] and 12-17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials.

Results: Of 2624 Ig20Gly infusions, >99% did not require any rate reduction, interruption or discontinuation due to adverse events (AEs). Median maximum infusion rates and volumes/site were higher in patients 12-17 years of age (30 ml/h/site; 30 ml/site) versus 6-11 years (20 ml/h/site; 15 ml/site) and 2-5 years (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs (0.009 and 0.063 AEs/infusion) were low.

Conclusion: Ig20Gly infused at relatively high rates and volumes was well tolerated in children.

Trial registration: ClinicalTrials.gov NCT01218438 NCT01412385.

Keywords: Ig20Gly; immunodeficiencies; pediatric; tolerability.

Publication types

Clinical Trial, Phase II
Clinical Trial, Phase III
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Child
Child, Preschool
Female
Humans
Immunoglobulins, Intravenous / administration & dosage*
Immunoglobulins, Intravenous / adverse effects
Infusions, Subcutaneous
Injections, Subcutaneous
Male
Primary Immunodeficiency Diseases / drug therapy*

Substances

Immunoglobulins, Intravenous

Associated data

ClinicalTrials.gov/NCT01218438
ClinicalTrials.gov/NCT01412385