Evidence map›Paper›PMID 33025378›Full record

ArticleJournal of clinical immunology2021

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.

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

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of clinical immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03033745 (An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03033745 phase4completednot on this map

An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency

TypeinterventionalSponsorCSL BehringRan2017 to 2018Enrolled49ConditionsPrimary ImmunodeficiencyArmsIgPro20
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Navigating primary and secondary immunodeficiency intersections: how to find IEI hidden within SID.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    Review
  4. Article
  5. Infusion parameters, safety, and practical guidance for the manual administration of subcutaneous immunoglobulin 20% (Ig20Gly).Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024
    Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 9 institutions in 4 countries.

Juthaporn CowanUniversity of Ottawa, 501 Smyth Road, Box 223, Ottawa, ON, K1H 8L6, Canada.
Vincent R BonaguraDonald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA.
Patricia L LugarDuke University Medical Center, 1821 Hillandale Rd, Suite 25A, Durham, NC, 27705, USA.
Paul J MaglioneBoston University School of Medicine, Pulmonary Center, R304, Boston, MA, 02118, USA.
Niraj C PatelLevine Children's Hospital, Atrium Health, 1000 Blythe Blvd, 32861, Charlotte, NC, 28232, USA.
Donald C VinhMcGill University Health Centre - Research Institute, 1001 Decarie Blvd, Block E, Rm EM3-3230 (Mail Drop: EM3-3211), Montreal, QC, H4A 3J1, Canada.
Jutta H HofmannCSL Behring AG, Wankdorfstrasse 10, 3014, Bern, Switzerland.
Michaela PrausCSL Behring GmbH, Emil-von-Behring-Straße 76, 35041, Marburg, Germany.
Mikhail A RojavinCSL Behring LLC, 1020 First Avenue, King of Prussia, PA, 19406, USA. mikhail.rojavin@cslbehring.com.ORCID 0000-0002-9010-2865
Behringwerke (Germany) · DEBoston University · USCSL (Switzerland) · CHCSL (United States) · USDuke University · USFeinstein Institute for Medical Research · USLevine Children's Hospital · USMcGill University Health Centre · CAUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and tolerability of IgPro20 manual push (also known as rapid push) infusions at flow rates of 0.5-2.0 mL/min.

methodsPatients with primary immunodeficiency (PID) with previous experience administering IgPro20 (Hizentra

resultsSixteen patients were treated; 2 patients (12.5%) discontinued at the 1.0-mL/min level (unrelated to treatment). Responder rates were 100%, 100%, and 87.5% at 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Mean weekly infusion duration decreased from 103-108 to 23-28 min at the 0.5- and 2.0-mL/min flow rates, respectively. Rates of treatment-related treatment-emergent adverse events (TEAEs) per infusion were 0.023, 0.082, and 0.025 for the 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Most TEAEs were mild local reactions and tolerability (infusions without severe local reactions/total infusions) was 100% across flow rate levels. Serum IgG levels (mean [SD]) were similar at study start (9.36 [2.53] g/L) and end (9.58 [2.12] g/L).

conclusionsSubcutaneous IgPro20 manual push infusions at flow rates up to 2.0 mL/min were well tolerated and reduced infusion time in treatment-experienced patients with PID.

trial registrationNCT03033745.

Indexed as

AdolescentAdultAgedDisease ManagementDrug MonitoringFemaleHumansImmunoglobulin GInfusion PumpsInfusions, SubcutaneousInjections, SubcutaneousMaleMiddle AgedPatient CompliancePrimary Immunodeficiency DiseasesTreatment OutcomeHizentraImmunoglobulin Ghigh infusion rateIgGmanual pushPrimary immunodeficiency (PID)subcutaneous Ig (SCIG)

Identifiers

PMID33025378
PMCPMC7846525
OpenAlexW3092180390

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.