Evidence map›Paper›PMID 40095398›Full record

ArticlePharmacoepidemiology and drug safety2025

A Comparative Real-World Study Evaluating the Safety of Immune Globulin Infusion (Human) 10% Solution and Other Intravenous Immunoglobulin Therapies for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony

Abstract readComparative Study
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

J Bradley LaytonRTI Health Solutions, Research Triangle Park, North Carolina, USA.ORCID 0000-0003-0994-5820
Colin Anderson-SmitsTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0002-2734-6154
Zhongwen HuangTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Hakan AyTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
William SpaldingTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Bilal KhokharTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Jie ZhouTakeda Development Center Americas, Inc, Cambridge, Massachusetts, USA.
Lee BennettRTI Health Solutions, Research Triangle Park, North Carolina, USA.
Mary S AnthonyRTI Health Solutions, Research Triangle Park, North Carolina, USA.ORCID 0000-0002-5201-1794

Funding

Takeda Development Center Americas, Inc
6 · The paper itself

Abstract

purposeImmune globulin infusion (human) 10% solution (GAMMAGARD LIQUID; GGL), an intravenous immunoglobulin (IVIG), has recently received U.S. approval for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). We evaluated thrombotic events, acute kidney injury (AKI), and hemolytic events among patients with CIDP initiating IVIG treatment with GGL, versus a U.S.-approved IVIG comparator for CIDP, in individual and combined cohorts of immunoglobulin (Ig)-naive and Ig-experienced participants.

methodsThis active-comparator, new-user, cohort study of patients with CIDP used the Merative MarketScan Research and Optum Clinformatics Data Mart databases (2008-2019). Outcomes were compared between adults receiving GGL and comparator IVIGs within propensity score-weighted samples using hazard ratios (HRs) and time period-specific risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CI). Database-specific results were meta-analyzed and appropriate.

resultsData from eligible patients in MarketScan (GGL, n = 1441; comparators, n = 2708) and Optum (GGL, n = 644; comparators, n = 1293) were analyzed. Across both databases, HRs, 1-year RRs, and 1-year RDs for thrombotic events did not suggest consistent differences in risk across treatment groups (e.g., MarketScan combined cohort: RR 1.14 [95% CI, 0.50 to 2.55]; Optum combined cohort: 0.60 [0.25 to 1.54]). Similarly, there was no difference in AKI risk between groups (e.g., MarketScan combined cohort: RR 1.25 [95% CI, 0.65 to 2.54]; Optum combined cohort: 0.65 [0.22 to 1.94]). Hemolytic events were rare.

conclusionsThrombotic events, AKI, and hemolytic events were rare among patients with CIDP receiving IVIG. There were no consistently different outcome risks between patients receiving GGL versus other IVIGs with US approval for CIDP.

Indexed as

Immunoglobulins, IntravenousPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingAcute Kidney InjuryAdultAgedCohort StudiesDatabases, FactualFemaleHumansMaleMiddle AgedPropensity ScoreRetrospective StudiesThrombosisUnited StatesImmunoglobulins, Intravenousacute kidney injurychronic inflammatory demyelinating polyradiculoneuropathydatabase studyhemolytic eventsimmune globulin infusion (human) 10% solutionintravenous immunoglobulin therapiesoutcome risksafetythrombotic events

Identifiers

PMID40095398
PMCPMC11912303

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.