Evidence map›Paper›PMID 37378806›Full record

Trial reportDrug safety2023

Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study.

David R Cornblath, Pieter A van Doorn, Hans-Peter Hartung, Ingemar S J Merkies, Hans D Katzberg, Doris Hinterberger, Elisabeth Clodi, ProCID Investigators

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02638207 (Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

NCT02638207 phase3completednot on this map

Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy

TypeinterventionalSponsorOctapharmaRan2017 to 2019Enrolled142ConditionsChronic Inflammatory Demyelinating Poly(Radiculo)NeuropathyArmsNewGam
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
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

8 authors at 8 institutions in 8 countries.

David R CornblathDepartment of Neurology, Johns Hopkins University, Baltimore, MD, 21287, USA. dcornbl@jhmi.edu.
Pieter A van DoornDepartment of Neurology, Erasmus University Medical Center, 3015 CE, Rotterdam, The Netherlands.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University, 40225, Düsseldorf, Germany.
Ingemar S J MerkiesDepartment of Neurology, Maastricht University Medical Center, 6229 HX, Maastricht, The Netherlands.
Hans D KatzbergDepartment of Neurology, University of Toronto, Toronto, M5G 2C4, Canada.
Doris HinterbergerOctapharma PPG, 1100, Vienna, Austria.
Elisabeth ClodiOctapharma PPG, 1100, Vienna, Austria.
ProCID Investigators
Octapharma (Austria) · ATUniversity of Curaçao · CWErasmus MC · NLUniversity of Toronto · CAJohns Hopkins University · USMaastricht University · NLPalacký University Olomouc · CZThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThe ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) preparation (panzyga

methodsPatients were randomised to receive a 2.0 g/kg induction dose followed by maintenance doses of either 0.5, 1.0 or 2.0 g/kg IVIg every 3 weeks over 24 weeks.

resultsAll 142 enrolled patients were included in the safety analyses. In total, 286 treatment-emergent adverse events (TEAEs) were reported in 89 patients, of which 173 (60.5%) were considered treatment-related. Most TEAEs were of mild severity. Eleven serious TEAEs were reported in 6 patients. Two serious TEAEs in one patient (headache and vomiting) were considered related to treatment, which resolved without study discontinuation. No treatment-related thrombotic events, haemolytic transfusion reactions or deaths occurred. One patient discontinued the study due to a TEAE (allergic dermatitis) probably related to IVIg. Headache was the only dose-dependent TEAE, with incidences ranging from 2.9 to 23.7%, the incidence of all other TEAEs was similar across treatment groups. Most TEAEs were associated with the induction dose infusion, and the rate of TEAEs decreased thereafter. The median (IQR) daily IVIg dose was 78 (64-90) g, and 94.4% of patients tolerated the maximal infusion rate of 0.12 ml/kg/min without pre-medication.

interpretationInfusions of 10% IVIg at doses up to 2.0 g/kg with high infusion rates were safe and well tolerated in patients with CIDP. CLINICAL TRIAL NUMBERS: EudraCT 2015-005443-14, NCT02638207.

Indexed as

Immunoglobulins, IntravenousPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingHeadacheHumansTreatment OutcomeImmunoglobulins, Intravenous

Identifiers

PMID37378806
PMCPMC10442284
OpenAlexW4382344417

What OpenQuestion holds

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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.