Evidence map›Paper›PMID 33206257›Full record

Trial reportJournal of clinical immunology2021

Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency.

Bas M Smits, Ilona Kleine Budde, Esther de Vries, Ineke J M Ten Berge, Robbert G M Bredius, Marcel van Deuren, Jaap T van Dissel, Pauline M Ellerbroek, Michiel van der Flier, P Martin van Hagen and 6 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.6field-weighted citation impact, top 34% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Observational
  6. Use of Immunoglobulin Replacement Therapy in Clinical Practice: A Review.Journal of immunotherapy and precision oncology · 2025
    Review
  7. Review
  8. Article
  9. 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

16 authors at 11 institutions in 1 country.

Bas M SmitsDepartment of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands.ORCID 0000-0002-2363-3789
Ilona Kleine BuddeClinical Operations, Sanquin Plasma Products B.V, Amsterdam, The Netherlands.
Esther de VriesDepartment of Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.
Ineke J M Ten BergeDepartment of Internal Medicine, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, The Netherlands.
Robbert G M BrediusDepartment of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.
Marcel van DeurenDepartment of Internal Medicine, Radboud UMC, Nijmegen, The Netherlands.
Jaap T van DisselDepartment of Infectious Diseases, Leiden University Medical Centre, University of Leiden, Leiden, The Netherlands.
Pauline M EllerbroekDivision of Internal Medicine and Dermatology, Department of Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.
Michiel van der FlierDepartment of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands.
P Martin van HagenDepartment of Internal Medicine/Immunology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Chris NieuwhofDepartment of Allergology and Clinical Immunology, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.
Bram RutgersDepartment of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Lieke E A M SandersDepartment of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands.
Anna SimonDepartment of Internal Medicine, Radboud UMC, Nijmegen, The Netherlands.
Taco W KuijpersDepartment of Paediatric Immunology and Infectious Diseases, Emma Children's Hospital, AUMC, University of Amsterdam, Amsterdam, The Netherlands.
Joris M van MontfransDepartment of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands. j.vanmontfrans@umcutrecht.nl.
Radboud University Nijmegen · NLUtrecht University · NLAmsterdam UMC Location University of Amsterdam · NLEmma Kinderziekenhuis · NLLeiden University · NLLeiden University Medical Center · NLMaastricht University Medical Centre · NLSanquin · NLTilburg University · NLUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with an IgG subclass deficiency (IgSD) ± specific polysaccharide antibody deficiency (SPAD) often present with recurrent infections. Previous retrospective studies have shown that prophylactic antibiotics (PA) and immunoglobulin replacement therapy (IRT) can both be effective in preventing these infections; however, this has not been confirmed in a prospective study.

objectiveTo compare the efficacy of PA and IRT in a randomized crossover trial.

methodsA total of 64 patients (55 adults and 9 children) were randomized (2:2) between two treatment arms. Treatment arm A began with 12 months of PA, and treatment arm B began with 12 months of IRT. After a 3-month bridging period with cotrimoxazole, the treatment was switched to 12 months of IRT and PA, respectively. The efficacy (measured by the incidence of infections) and proportion of related adverse events in the two arms were compared.

resultsThe overall efficacy of the two regimens did not differ (p = 0.58, two-sided Wilcoxon signed-rank test). A smaller proportion of patients suffered a related adverse event while using PA (26.8% vs. 60.3%, p < 0.0003, chi-squared test). Patients with persistent infections while using PA suffered fewer infections per year after switching to IRT (2.63 vs. 0.64, p < 0.01).

conclusionWe found comparable efficacy of IRT and PA in patients with IgSD ± SPAD. Patients with persistent infections during treatment with PA had less infections after switching to IRT. CLINICAL IMPLICATION: Given the costs and associated side-effects of IRT, it should be reserved for patients with persistent infections despite treatment with PA.

Indexed as

Antibiotic ProphylaxisChildFemaleHumansIgG DeficiencyImmunoglobulin GImmunologic Deficiency SyndromesMaleMiddle AgedPersistent InfectionPrimary Immunodeficiency DiseasesImmunoglobulin GIgSDimmunoglobulin replacement therapyIRTprimary antibody deficiencyPrimary immunodeficiencyprophylactic antibioticsrandomized controlled trialRCTSPAD

Identifiers

PMID33206257
PMCPMC7858555
OpenAlexW3098812041

What OpenQuestion holds

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Registered trials

None linked

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.