Evidence map›Paper›PMID 34036490›Full record

ArticleJournal of clinical immunology2021

Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin.

Zhaoyang Li, Barbara McCoy, Werner Engl, Leman Yel

2 registry-linked trialsOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.1field-weighted citation impact, top 61% 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.

NCT01218438 phase2 / phase3completednot on this map

A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

TypeinterventionalSponsorBaxalta now part of ShireRan2013 to 2015Enrolled86ConditionsPrimary Immunodeficiency Diseases (PID)ArmsImmune Globulin Intravenous (Human), 10% Solution, Immune Globulin Subcutaneous (Human), 20% Solution
NCT01412385 phase2 / phase3completednot on this map

A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases

TypeinterventionalSponsorBaxalta now part of ShireRan2011 to 2014Enrolled55ConditionsPrimary Immunodeficiency Diseases (PID)ArmsImmune Globulin Subcutaneous (Human), 20%, Immune Globulin Intravenous (Human), 10%, Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
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

4 authors at 2 institutions in 2 countries.

Zhaoyang LiShire Human Genetic Therapies, Inc., a Takeda company, 650 East Kendall Street, Cambridge, MA, 02142, USA. zhaoyang.li@takeda.com.
Barbara McCoyBaxalta Innovations GmbH, a Takeda company, Vienna, Austria.
Werner EnglBaxalta Innovations GmbH, a Takeda company, Vienna, Austria.
Leman YelBaxalta US Inc., a Takeda company, Cambridge, MA, USA.
Takeda (Austria) · ATTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with primary immunodeficiency diseases often require lifelong immunoglobulin (IG) therapy. Most clinical trials investigating IG therapies characterize serum immunoglobulin G (IgG) pharmacokinetic (PK) profiles by serially assessing serum IgG levels. This retrospective analysis evaluated whether steady-state serum IgG trough level measurement alone is adequate for PK assessment. Based on individual patient serum IgG trough levels from two pivotal trials (phase 2/3 European [NCT01412385] and North American [NCT01218438]) of weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly), trough level-predicted IgG AUC (AUC

Indexed as

Clinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansImmunoglobulin GImmunoglobulins, IntravenousImmunologic Deficiency SyndromesMulticenter Studies as TopicPrimary Immunodeficiency DiseasesProspective StudiesRetrospective StudiesImmunoglobulin GImmunoglobulins, IntravenousCuvitruintravenous immunoglobulinPharmacokineticsprimary immunodeficiency diseasessubcutaneous immunoglobulin

Identifiers

PMID34036490
PMCPMC8310849
OpenAlexW3164153032

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.