Evidence map›Paper›PMID 16758340›Full record

Trial reportJournal of clinical immunology2006

Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study.

Ann Gardulf, Uwe Nicolay, Oscar Asensio, Ewa Bernatowska, Andreas Böck, Beatriz Costa Carvalho, Carl Granert, Stefan Haag, Dolores Hernández, Peter Kiessling and 6 more

3 registry-linked trialsAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of clinical immunology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 80 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 4 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT00661401 nacompletednot on this map

Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions

TypeinterventionalSponsorFederal University of São PauloRan2002 to 2002Enrolled5ConditionsCommon Variable Immunodeficiency, AgammaglobulinemiaArmsgammaglobulin
NCT02123615 phase1 / phase2unknown statusnot on this mapstarted 2016, after this paper: background citation

ASIS for GAMMAGARD in Primary Immunodeficiency

TypeinterventionalSponsorASIS CorporationRan2016 to 2016Enrolled60ConditionsPrimary ImmunodeficiencyArmsGadolinium For abdomen, Gadolinium For lower back, Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, Efficacy of Gammagard subcutaneously at Week 36
NCT02503293 phase4completednot on this mapstarted 2015, after this paper: background citation

A Randomised, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push

TypeinterventionalSponsorOctapharmaRan2015 to 2017Enrolled30ConditionsPrimary ImmunodeficiencyArmsChrono Super PID then Generic Syringe-Gammanorm, Generic Syringe then Chrono Super PID-Gammanorm
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 4 syntheses or guidelines pooled it, 189 citations in OpenAlex.

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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 14 institutions in 6 countries.

Ann GardulfDepartment of Laboratory Medicine, Section of Clinical Immunology, The Swedish Centre for Immunodeficiencies, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden. ann.gardulf@ki.se
Uwe Nicolay
Oscar Asensio
Ewa Bernatowska
Andreas Böck
Beatriz Costa Carvalho
Carl Granert
Stefan Haag
Dolores Hernández
Peter Kiessling
Jan Kus
Jaune Pons
Tim Niehues
Sigune Schmidt
Ilka Schulze
Michael Borte
Karolinska University Hospital · SEBehringwerke (Germany) · DEChildren's Memorial Health Institute · PLCSL (Germany) · DEDeleted InstitutionDüsseldorf University Hospital · DEHospital Universitari i Politècnic La Fe · ESHospital Universitario Son Dureta · ESHumboldt-Universität zu Berlin · DELeipzig University · DENational Institute of Public Health · PLUniversidade Federal de São Paulo · BRUniversitätsklinik für Kinder und Jugendpsychiatrie · ATUniversity Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sixty patients (16 children, 44 adults) participated in the study aiming at evaluating: (i) IgG levels when switching patients from intravenous IgG (IVIG) infusions in hospital to subcutaneous (SCIG) self-infusions at home using the same cumulative monthly dose, (ii) protections against infections, and (iii) safety of a new, ready-to-use 16% IgG preparation. All children and 33 adults had received IVIG therapy for >6 months at enrolment. Ten adults who had been on SCIG therapy for many years served as controls. Mean serum IgG trough levels increased in the pre-IVIG children from 7.8 to 9.2 g/L (non-inferiority: p < 0.001) and in the adults from 8.6 to 8.9 g/L (non-inferiority: p < 0.001). Totally 114 respiratory tract infections occurred, 90% of them mild. One serious bacterial infection (pneumonia) was reported for one adult. The annualized rate of serious infections was 0.04 episodes/patient. In total 2297 infusions were given and 28 (1%) systemic adverse reactions occurred, none of them severe. Local tissue reactions declined over time, this being particularly distinct after 8 to 10 weeks. In conclusion, the SCIG administration route was safe. High IgG levels were easily maintained resulting in a very good protection against infections.

Indexed as

AdolescentAdultAgedChildChild, PreschoolFemaleHumansImmunoglobulin GImmunoglobulins, IntravenousImmunologic Deficiency SyndromesInfectionsInjections, SubcutaneousLiver Function TestsLongitudinal StudiesMaleMiddle AgedImmunoglobulin GImmunoglobulins, Intravenous

Identifiers

PMID16758340
OpenAlexW2058522501

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.