Evidence map›Paper›PMID 32575458›Full record

ReviewAntibodies (Basel, Switzerland)2020

Considerations for Optimizing Dosing of Immunoglobulins Based on Pharmacokinetic Evidence.

Iftekhar Mahmood, Million A Tegenge, Basil Golding

Open access · goldAbstract readReview
In one paragraph

Review in Antibodies (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

15 citing papers in PubMed, 34 citations in OpenAlex.

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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 at 1 institution in 1 country.

Iftekhar MahmoodDivision of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), Food & Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Million A TegengeOffice of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research (CBER), Food & Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Basil GoldingDivision of Plasma Protein Therapeutics, Office of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), Food & Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.
Center for Biologics Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immunoglobulins (IGs) are widely used for the treatment of immunodeficiency syndromes and several autoimmune diseases. In neonates, IGs have been used for the treatment of alloimmune thrombocytopenia, in neonatal infections and in the rare cases of neonatal Kawasaki disease. This review aims to examine the various dosing regimens of IGs following intravenous (IV) and subcutaneous (SC) administration, pharmacokinetics (PK) of IGs, and the importance of trough values for the prevention of infections in patients with primary immune deficiency (PID). The review also focuses on the mechanism of catabolism of IGs and the impact on the half-life of IGs. Data and reviews were obtained from the literature and the FDA package inserts. The authors suggest that for dosing, the PK of IGs should be evaluated on the baseline-corrected concentrations since this approach provides an accurate estimate of half-life and clearance of IGs. We also suggest employing clearance as a primary PK parameter for dosing determination of IGs. We suggest that IV dosing would be more effective if given more frequently to adjust for the increased clearance at high doses and because the baseline-corrected half-life is much shorter than the baseline-uncorrected half-life. Regarding SC administration, the dose should be adjusted based on the absolute bioavailability (determined against IV dosing) of the product. Finally, we highlight clinical and PK data gaps for optimum and individualized dosing of IGs.

Indexed as

clearancedosehalf-lifeimmunoglobulinsneonatesprimary immune deficiency

Identifiers

PMID32575458
PMCPMC7345246
OpenAlexW3036554005

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.