Evidence map›Paper›PMID 20696632›Full record

Trial reportEuropean journal of medical research2010

Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency.

F Hoffmann, B Grimbacher, J Thiel, H-H Peter, B H Belohradsky, Vivaglobin Study Group

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in European journal of medical research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06089122 (Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG in Patients With Primary Immunodeficiency), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT06089122 phase3unknown statusnot on this mapstarted 2024, after this paper: background citation

Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG in Patients With Primary Immunodeficiency

TypeinterventionalSponsorAzidus BrasilRan2024 to 2025Enrolled50ConditionsPrimary Immunodeficiency DiseaseArmsIVIG
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Article
  5. Review
  6. Article
  7. Article
  8. Immunoglobulin replacement therapy in patients with immunodeficiencies: impact of infusion method on patient-reported outcomes.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Article
  9. A clinician's guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Adverse Effects of Immunoglobulin Therapy.Frontiers in immunology · 2018
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

6 authors.

F HoffmannUniversity Children's Hospital, Paediatric Infectious Diseases and Immunology, Ludwig Maximilians University, Munich, Germany. Florian.Hoffmann@med.uni-muenchen.de
B Grimbacher
J Thiel
H-H Peter
B H Belohradsky
Vivaglobin Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubcutaneous immunoglobulin (SCIG) therapy is an alternative to intravenous immunoglobulin (IVIG) therapy.

methodsWe evaluated the efficacy and safety of the SCIG Vivaglobin(formerly known as Beriglobin SC) under real-life conditions in a post-marketing observational study in 82 patients with primary or secondary antibody deficiencies. Health-related quality of life (HRQoL) was evaluated in a subset of 30 patients previously treated with IVIG (including 11 children <14 years) using the Short Form 36 (SF-36) for patients > or = 14 years of age (adults) and the Child Health Questionnaire - Parental Form 50 (CHQ-PF50) for children <14 years of age. Treatment preferences were assessed in adults.

resultsThe mean serum immunoglobulin G (IgG) trough level during SCIG treatment (7.5 g/L) was higher than during previous IVIG treatment (6.6 g/L; p<0.01). The investigators assessed the efficacy of SCIG therapy as "excellent" in 89% of patients. No systemic adverse drug reactions were observed. Improvements by > or = 5 points were observed in 5 of 8 SF-36 subscales and in 6 of 12 CHQ-PF50 subscales. Statistically significant improvements (p< or =0.05) were observed for the SF-36 subscales of bodily pain, general health perceptions, and vitality (adults), and for the CHQ-PF50 subscales of general health perceptions, parental impact - time, parental impact - emotional, and family activities (children). Patients preferred SCIG over IVIG therapy (92%) and home therapy over therapy at the clinic/physician (83%).

conclusionThis study confirms that therapy with Vivaglobin at home is effective, safe, well tolerated, and improves quality of life in patients with antibody deficiency.

Indexed as

AdolescentAdultAgedChildChild, PreschoolFemaleHealth StatusHumansImmunoglobulinsImmunologic Deficiency SyndromesImmunotherapyInfantInjections, SubcutaneousMaleMiddle AgedProduct Surveillance, PostmarketingImmunoglobulinsVivaglobin

Identifiers

PMID20696632
PMCPMC3351992

What OpenQuestion holds

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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.