Evidence map›Paper›PMID 31325017›Full record

Trial reportJournal of neurology2019

Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy.

Ingrid J T Herraets, Jaap N E Bakers, Ruben P A van Eijk, H Stephan Goedee, W Ludo van der Pol, Leonard H van den Berg

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Journal of neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 30% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Immunoglobulin for multifocal motor neuropathy.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. 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

6 authors at 1 institution in 2 countries.

Ingrid J T HerraetsDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Center Rudolf Magnus, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Jaap N E BakersDepartment of Rehabilitation, Brain Center Rudolf Magnus, UMC Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Ruben P A van EijkDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Center Rudolf Magnus, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
H Stephan GoedeeDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Center Rudolf Magnus, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
W Ludo van der PolDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Center Rudolf Magnus, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Leonard H van den BergDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Center Rudolf Magnus, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. l.h.vandenberg@umcutrecht.nl.
University Medical Center Utrecht · NL

Funding

Takeda BT14-23778/IIR-NLD-BXLT-001965
6 · The paper itself

Abstract

objectiveThe primary aim was to determine the safety of treatment with human immune globulin 10% with recombinant human hyaluronidase (fSCIg) compared to intravenous immunoglobulin (IVIg) in a prospective open-label study in patients with multifocal motor neuropathy (MMN).

methodsOur study consisted of two phases: the IVIg phase (visits 1-3; 12 weeks), in which patients remained on IVIg treatment, and the fSCIg phase (visits 4-7; 36 weeks), in which patients received fSCIg treatment. After visit 3, IVIg was switched to an equivalent dose and frequency of fSCIg. Outcome measures were safety, muscle strength, disability and treatment satisfaction.

resultsEighteen patients were enrolled in this study. Switching to fSCIg reduced the number of systemic adverse events (IVIg 11.6 vs. fSCIg 5.0 adverse events/per person-year, p < 0.02), and increased the number of local reactions at the injection site (IVIg 0 vs. fSCIg 3.3 local reactions/per person-year, p < 0.01). Overall, no significant differences in muscle strength and disability between fSCIg and IVIg were found. Treatment with fSCIg was perceived as optimal treatment option by 8 of the 17 patients (47.1%) and they continued with fSCIg after study closure because of improved independence and flexibility to administer treatment.

conclusionTreatment with fSCIg can be considered a safe alternative for patients with MMN on IVIg treatment. fSCIg could be a favorable option in patients who prefer self-treatment and more independency, and in patients who experience systemic adverse events on IVIg or have difficult intravenous access.

Indexed as

AdultAgedFemaleHumansHyaluronoglucosaminidaseImmunoglobulins, IntravenousMaleMiddle AgedMuscle StrengthPolyneuropathiesPolyradiculoneuropathyRecombinant ProteinsTreatment OutcomeHyaluronoglucosaminidaseImmunoglobulins, IntravenousRecombinant ProteinsImmunoglobulinMultifocal motor neuropathyPeripheral neuropathySafetyTreatment effect

Identifiers

PMID31325017
PMCPMC6803588
OpenAlexW2963397443

What OpenQuestion holds

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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.