Evidence map›Paper›PMID 40247653›Full record

Trial reportEuropean journal of neurology2025

The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

Mamatha Pasnoor, Colin Anderson-Smits, Todd Levine, Vera Bril, Juan Marcos Solano, Konrad Rejdak, Josep Gamez, Elisabeth Chroni, Carlos Casasnovas, Enrico Marchioni and 13 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European journal of neurology, 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. Observational
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

23 authors.

Mamatha PasnoorUniversity of Kansas Medical Center, Kansas City, Kansas, USA.
Colin Anderson-SmitsTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
Todd LevineCND Life Sciences, Phoenix, Arizona, USA.
Vera BrilThe Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-5805-4883
Juan Marcos SolanoIPS Universitaria and Neuromuscular Disorders Research Group, University of Antioquia, Medellín, Colombia.
Konrad RejdakDepartment of Neurology, Medical University of Lublin, Lublin, Poland.
Josep GamezDepartment of Neurology, GMA Clinic, Barcelona, Spain.ORCID 0000-0003-3127-7486
Elisabeth ChroniDepartment of Neurology, Medical School, University of Patras, Rion, Achaia, Greece.ORCID 0000-0001-9237-4963
Carlos CasasnovasBellvitge University Hospital, Barcelona, Spain.ORCID 0000-0003-1170-2676
Enrico MarchioniIRCCS Fondazione Mondino, Pavia, Italy.
Gabriele SicilianoUniversity Hospital of Pisa, Pisa, Italy.
Dario CocitoUniversity of Turin, Turin, Italy.
K SivakumarNeuromuscular Clinic and Research Center of Arizona, Phoenix, Arizona, USA.
Alberto RiveroInstitute for Neurological Research (FLENI), Buenos Aires, Argentina.
Kim DuffTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
Erin GrecoTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
Massimo CorboDepartment of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy.
Shabbir HasanTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
Amir DoriDepartment of Neurology, Chaim Sheba Medical Center, Ramat Gan, Israel.ORCID 0000-0003-4633-1481
Jens SchmidtDepartment of Neurology, Neuromuscular Center, University Medical Center Göttingen, Göttingen, Germany.
Jamie WoodTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
Zhaoyang LiTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
Hakan AyTakeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-9146-0218

Funding

Takeda Development Center Americas, Inc.
6 · The paper itself

Abstract

backgroundADVANCE-CIDP IVIG evaluated the efficacy and safety of immune globulin infusion (human) 10% solution (IVIG 10%; GAMMAGARD LIQUID, also known as Kiovig) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as a rescue treatment for patients relapsing during the ADVANCE-CIDP 1 trial.

methodsOpen-label ADVANCE-CIDP IVIG included adult patients with confirmed CIDP relapse (≥ 1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] disability scores from pre-treatment baseline) during ADVANCE-CIDP 1, which assessed the efficacy and safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10%. Patients received an induction IVIG 10% dose (2 g/kg) followed by maintenance infusions at the same monthly equivalent dose of pre-randomization IVIG, 3-weekly for 6 months. The primary outcome was the responder rate (≥ 1-point decrease in adjusted INCAT scores at treatment cessation vs. pre-IVIG 10% baseline, in patients receiving placebo in ADVANCE-CIDP 1). Other outcomes included the responder rate across all patients relapsing on fSCIG 10% or placebo in ADVANCE-CIDP 1, time to functional improvement (≥ 1-point decrease in adjusted INCAT score), and change in adjusted INCAT scores and Rasch-built Overall Disability Scale (R-ODS) centile scores from pre-IVIG 10% baseline.

resultsOverall, 20 patients received IVIG 10% (n = 4 [fSCIG 10%-relapse group]; n = 16 [placebo-relapse group]). Responder rate (95% confidence interval) was 100.0% (80.6%-100.0%) in the placebo-relapse group and 95.0% (76.4%-99.1%) in the overall-relapse population. Across all patients, median time to functional improvement was 25 days. At treatment cessation, mean changes from pre-IVIG 10% baseline in adjusted INCAT and R-ODS centile scores were -1.9 and 12.9, respectively.

conclusionsIVIG 10% effectively treated CIDP relapse and improved functional abilities.

Indexed as

Immunoglobulins, IntravenousImmunologic FactorsPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingAdultAgedFemaleHumansMaleMiddle AgedRecurrenceTreatment OutcomeImmunoglobulins, IntravenousImmunologic Factorschronic inflammatory demyelinating polyradiculoneuropathyimmunoglobulin Gintravenous immunoglobulintreatment efficacy

Identifiers

PMID40247653
PMCPMC12006664

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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.