Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents

Daniel Suez; Gergely Kriván; Stephen Jolles; Mark Stein; Sudhir Gupta; Kenneth Paris; P Martin van Hagen; Nicholas Brodszki; Werner Engl; Heinz Leibl; Barbara McCoy; Leman Yel

doi:10.2217/imt-2019-0057

Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents

Immunotherapy. 2019 Aug;11(12):1057-1065. doi: 10.2217/imt-2019-0057. Epub 2019 Jul 3.

Authors

Daniel Suez¹, Gergely Kriván², Stephen Jolles³, Mark Stein⁴, Sudhir Gupta⁵, Kenneth Paris⁶, P Martin van Hagen⁷, Nicholas Brodszki⁸, Werner Engl⁹, Heinz Leibl¹⁰, Barbara McCoy¹⁰, Leman Yel^{11

12}

Affiliations

¹ Allergy, Asthma & Immunology Clinic, PA, Irving, TX 75063, USA.
² Department of Pediatric Hematology & Stem Cell Transplantation, Szent László Hospital, Budapest, Hungary.
³ Immunodeficiency Centre for Wales, University Hospital of Wales, Heath Park, Cardiff, UK.
⁴ Allergy Associates of the Palm Beaches, North Palm Beach, FL 33408, USA at the time of this study.
⁵ Division of Basic & Clinical Immunology, University of California at Irvine, Irvine, CA 92697, USA.
⁶ Department of Pediatrics, LSU Health Sciences Center New Orleans, Children's Hospital of New Orleans, New Orleans, LA 70118, USA.
⁷ Department of Internal Medicine/Clinical Immunology, Erasmus University Medical Center, Rotterdam, Netherlands.
⁸ Department of Pediatric Oncology/Immunology, Skåne University Hospital, Lund, Sweden.
⁹ Biostatistics, The Takeda Group of Companies, Vienna, Austria.
¹⁰ Clinical Research Immunology, The Takeda Group of Companies, Vienna, Austria.
¹¹ Research & Development, Plasma Derived Therapies Business Unit, The Takeda Group of Companies, Cambridge, MA 02142, USA.
¹² Department of Medicine, University of California at Irvine, CA 92697, USA.

PMID: 31268374
DOI: 10.2217/imt-2019-0057

Abstract

Aim: This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two Phase II/III studies conducted in North America and Europe. Patients & materials/methods: Patients received Ig20Gly (volumes, ≤60 ml/site; rates, ≤60 ml/h/site). Adverse events (AEs), tolerability and infusion parameters were assessed. Results: Patients (2-83 years; N = 122) received 6676 Ig20Gly infusions. No causally related serious or severe AEs were reported. Thirty-five patients (28.7%) reported 232 causally related local AEs. Twenty-seven patients (22.1%) reported 165 causally related systemic AEs. There was no association between the infusion volume or rate and causally related local AEs. Conclusion: Ig20Gly was well tolerated in a broad population of patients with primary immunodeficiency diseases.

Trial registration: ClinicalTrials.gov NCT01412385 NCT01218438.

Keywords: CUVITRU; Ig20Gly; common variable immune deficiency; immunoglobulin; immunoglobulin replacement therapy (IgRT); primary immunodeficiency; safety; subcutaneous; tolerability.

Publication types

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

MeSH terms

Adolescent
Adult
Aged
Aged, 80 and over
Child
Child, Preschool
Drug-Related Side Effects and Adverse Reactions / epidemiology*
Europe
Female
Humans
Immunoglobulin G / therapeutic use*
Injections, Subcutaneous
Male
Middle Aged
North America
Primary Immunodeficiency Diseases / drug therapy*
Primary Immunodeficiency Diseases / epidemiology
Prospective Studies
Young Adult

Substances

Immunoglobulin G

Associated data

ClinicalTrials.gov/NCT01412385
ClinicalTrials.gov/NCT01218438