Evidence map›Paper›PMID 26910102›Full record

Trial reportJournal of clinical immunology2016

Quantitative Evidence of Wear-Off Effect at the End of the Intravenous IgG (IVIG) Dosing Cycle in Primary Immunodeficiency.

Mikhail A Rojavin, Alphonse Hubsch, John-Philip Lawo

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical immunology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–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.

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

26 citing papers in PubMed.

  1. Trial
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  8. Observational
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  17. Observational
  18. Pediatric subset of primary immunodeficiency patients treated with SCIG: post hoc analysis of SHIFT and IBIS pooled data.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2020
    Article
  19. Review
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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

3 authors.

Mikhail A RojavinClinical Research and Development, CSL Behring LLC, King of Prussia, PA, USA. Mikhail.Rojavin@cslbehring.com.
Alphonse HubschMedical Affairs, CSL Behring AG, Berne, Switzerland.
John-Philip LawoClinical Research and Development, CSL Behring GmbH, Marburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIntravenous IgG (IVIG) treatment wear-off is commonly experienced by patients, who report increased susceptibility to infection, and decreased quality of life towards the end of their 3- or 4-week dosing cycle, when serum IgG levels approach their trough. We quantified IVIG wear-off in terms of treatment efficacy and patient well-being.

methodsData were collected from patients enrolled in three Phase III trials of Sandoglobulin NF Liquid or Privigen, treated every 3- or 4- weeks. Pooled analyses of raw patient data compared the rate of infection and other clinical outcomes during the course of the dosing cycle. Subjective symptoms of wear-off were quantified by comparing patient-reported overall well-being scores.

resultsThe probability of a first infection in the final week of the IVIG cycle was 1.26 (95% confidence intervals [CI]: 0.76-2.11; p = 0.3621) and 1.55 (95% CI: 1.04-2.32; p = 0.0314) times higher than in the first week, for patients on a 3-week cycle and 4-week dosing cycles, respectively. Wear-off, as manifested by a decrease in overall well-being, was experienced in 10% of all cycles and reported at least once by 61% of the patients on a 3-week cycle, and 43% of those on a 4-week cycle.

conclusionsThese findings confirm the existence of decreased efficacy (treatment wear-off) towards the end of a 3-4 week IVIG dosing cycle, and provide a quantifiable evaluation to a phenomenon typically reported anecdotally. For patients experiencing wear-off, increasing the IgG dose or shortening the dosing interval and/or a switch to SCIG may be beneficial.

Indexed as

AdolescentAdultAgedChildChild, PreschoolDrug ResistanceFemaleHumansImmunoglobulin GImmunoglobulins, IntravenousImmunologic Deficiency SyndromesInfusions, SubcutaneousMaleMiddle AgedQuality of LifeTreatment OutcomeImmunoglobulin GImmunoglobulins, Intravenousend-dose effectImmunoglobulin replacement therapyivigprimary immunodeficiencyscigwear-offwell-being

Identifiers

PMID26910102
PMCPMC4792336

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Registered trials

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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.