Literature DB >> 33409867

Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study.

John T Anderson1, Vincent R Bonagura2,3, Juthaporn Cowan4, Connie Hsu5, S Shahzad Mustafa6,7, Niraj C Patel8, John M Routes9, Panida Sriaroon10, Donald C Vinh11, Jutta H Hofmann12, Michaela Praus13, Mikhail A Rojavin14.   

Abstract

PURPOSE: To evaluate the safety and tolerability of subcutaneous IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) administered at high infusion parameters (> 25 mL and > 25 mL/h per injection site) in patients with primary immunodeficiency.
METHODS: The Hizentra® Label Optimization (HILO) study was an open-label, parallel-arm, non-randomized study (NCT03033745) of IgPro20 using a forced upward titration design for infusion parameters. Patients experienced with pump-assisted IgPro20 infusions received weekly IgPro20 infusions at a stable dose in the Pump-Assisted Volume Cohort (N = 15; 25-50 mL per injection site) and in the Pump-Assisted Flow Rate Cohort (N = 18; 25-100 mL/h per injection site). Responder rates (percentage of patients who successfully completed ≥ 75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated.
RESULTS: Responder rates were 86.7% (13/15, 25 mL) and 73.3% (11/15, 40 and 50 mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50 mL/h), 66.7% (12/18, 75 mL/h), and 61.1% (11/18, 100 mL/h) in the Flow Rate Cohort. Infusion compliance was ≥ 90% in all patients in the Volume Cohort and in 83.3% of patients in the Flow Rate Cohort. The number of injection sites (Volume Cohort) and the infusion duration (Flow Rate Cohort) decreased with increasing infusion parameters. The rate of treatment-emergent adverse events per infusion was low (0.138 [Volume Cohort] and 0.216 [Flow Rate Cohort]). Serum IgG levels remained stable during the study.
CONCLUSION: Pump-assisted IgPro20 infusions are feasible at 50 mL and 100 mL/h per injection site in treatment-experienced patients, which may result in fewer injection sites and shorter infusion times. TRIAL REGISTRATION: NCT03033745 ; registered January 27, 2017.

Entities:  

Keywords:  IgPro20; Primary immunodeficiency (PID); high infusion flow rate; high infusion volume; pump-assisted infusion; subcutaneous Ig (SCIG)

Mesh:

Substances:

Year:  2021        PMID: 33409867      PMCID: PMC7858210          DOI: 10.1007/s10875-020-00912-5

Source DB:  PubMed          Journal:  J Clin Immunol        ISSN: 0271-9142            Impact factor:   8.317


  24 in total

1.  Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease.

Authors:  Stephen Jolles; Michael Borte; Robert P Nelson; Mikhail Rojavin; Martin Bexon; John-Philip Lawo; Richard L Wasserman
Journal:  Clin Immunol       Date:  2013-10-26       Impact factor: 3.969

Review 2.  Subcutaneous immunoglobulin replacement therapy with Hizentra, the first 20% SCIG preparation: a practical approach.

Authors:  S Jolles; J W Sleasman
Journal:  Adv Ther       Date:  2011-06-14       Impact factor: 3.845

Review 3.  Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease.

Authors:  S Jolles; J S Orange; A Gardulf; M R Stein; R Shapiro; M Borte; M Berger
Journal:  Clin Exp Immunol       Date:  2015-02       Impact factor: 4.330

4.  "Experiences of the burden of treatment"-Patient reports of facilitated subcutaneous immunoglobulin treatment in adults with immunodeficiency.

Authors:  Christina Petersson; Ramona Fust; Carina Hagstedt; Per Wågström; Åsa Nilsdotter-Augustinsson
Journal:  J Clin Nurs       Date:  2018-07-26       Impact factor: 3.036

5.  Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency.

Authors:  Waleed Al-Herz; Aziz Bousfiha; Jean-Laurent Casanova; Helen Chapel; Mary Ellen Conley; Charlotte Cunningham-Rundles; Amos Etzioni; Alain Fischer; Jose Luis Franco; Raif S Geha; Lennart Hammarström; Shigeaki Nonoyama; Luigi Daniele Notarangelo; Hans Dieter Ochs; Jennifer M Puck; Chaim M Roifman; Reinhard Seger; Mimi L K Tang
Journal:  Front Immunol       Date:  2011-11-08       Impact factor: 7.561

6.  A cohort of French pediatric patients with primary immunodeficiencies: are patient preferences regarding replacement immunotherapy fulfilled in real-life conditions?

Authors:  Marlène Pasquet; Isabelle Pellier; Nathalie Aladjidi; Anne Auvrignon; Patrick Cherin; Pierre Clerson; Gregoire Jacques Noël Cozon; Roland Jaussaud; Boris Bienvenu; Cyrille Hoarau
Journal:  Patient Prefer Adherence       Date:  2017-07-10       Impact factor: 2.711

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

Authors:  Daniel Suez; Mark Stein; Sudhir Gupta; Iftikhar Hussain; Isaac Melamed; Kenneth Paris; Amy Darter; Christelle Bourgeois; Sandor Fritsch; Heinz Leibl; Barbara McCoy; David Gelmont; Leman Yel
Journal:  J Clin Immunol       Date:  2016-08-31       Impact factor: 8.317

8.  Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients.

Authors:  Boris Bienvenu; Grégoire Cozon; Yves Mataix; Dominique Lachaud; Antoine Alix; Cyrille Hoarau; Daniel Antier; Eric Hachulla; Sylvie Brice; Jean-François Viallard; Stéphanie Tamisier; Anne-Laure Fauchais; Françoise Renon-Carron; Pierre Clerson; Yann Fardini; Jean-Charles Crave; Pierre Miossec
Journal:  J Clin Immunol       Date:  2018-05-31       Impact factor: 8.317

9.  Correlations Among Subcutaneous Immunoglobulin Dosage, Immunoglobulin G Serum Pre-infusional Levels and Body Mass Index in Primary Antibody Deficiency Patients: A Pooled Analysis from the SHIFT/IBIS Studies.

Authors:  Antonio Pecoraro; Silvia Ricci; Alessandra Vultaggio; Giorgio Maria Boggia; Giuseppe Spadaro
Journal:  Clin Drug Investig       Date:  2020-03       Impact factor: 2.859

10.  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.

Authors:  M Borte; G Kriván; B Derfalvi; L Maródi; T Harrer; S Jolles; C Bourgeois; W Engl; H Leibl; B McCoy; D Gelmont; L Yel
Journal:  Clin Exp Immunol       Date:  2016-10-18       Impact factor: 4.330

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  1 in total

1.  Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study.

Authors:  Juthaporn Cowan; Vincent R Bonagura; Patricia L Lugar; Paul J Maglione; Niraj C Patel; Donald C Vinh; Jutta H Hofmann; Michaela Praus; Mikhail A Rojavin
Journal:  J Clin Immunol       Date:  2020-10-06       Impact factor: 8.317

  1 in total

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