Evidence map›Paper›PMID 30672091›Full record

Trial reportJournal of the peripheral nervous system : JPNS2019

Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.

Ingemar S J Merkies, Ivo N van Schaik, Jean-Marc Léger, Vera Bril, Nan van Geloven, Hans-Peter Hartung, Richard A Lewis, Gen Sobue, John-Philip Lawo, Billie L Durn and 10 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the peripheral nervous system : JPNS, 2019. 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 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT01184846 phase3completednot on this map

A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

TypeinterventionalSponsorCSL BehringRan2010 to 2011Enrolled31ConditionsChronic Inflammatory Demyelinating PolyneuropathyArms10% liquid formulation of human immunoglobulin
NCT01545076 phase3completednot on this map

Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

TypeinterventionalSponsorCSL BehringRan2012 to 2016Enrolled208ConditionsChronic Inflammatory Demyelinating Polyneuropathy, PolyradiculoneuropathyArmsIgPro20 (low dose), Placebo, IgPro10, IgPro20 (high dose)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.Journal of the peripheral nervous system : JPNS · 2019
    Trial
  6. Observational
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. 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

20 authors at 17 institutions in 11 countries.

Ingemar S J MerkiesDepartment of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.
Ivo N van SchaikDepartment of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Jean-Marc LégerNational Referral Center for Rare Neuromuscular Diseases, Hôpital Pitié-Salpêtrière and University Paris VI, Paris, France.
Vera BrilEllen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.
Nan van GelovenDepartment of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands.
Hans-Peter HartungDepartment of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
Richard A LewisDepartment of Neurology, Cedars-Sinai Medical Center, Los Angeles, California.
Gen SobueDepartment of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
John-Philip LawoCSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.
Billie L DurnCSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.
David R CornblathDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Jan L De BleeckerDepartment of Neurology, AZ St-Lucas, Ghent, Belgium.
Claudia SommerDepartment of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany.
Wim RobberechtDepartment of Neurosciences, UZ Leuven, Leuven, Belgium.
Mika SaarelaDepartment of Neurology, Helsinki University Central Hospital, Helsinki, Finland.
Jerzy KamienowskiDolnośląski Szpital Specjalistyczny, Wrocław, Poland.
Zbigniew StelmasiakDepartment of Neurology, Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland.
Björn TackenbergDepartment of Neurology, Philipps University, Marburg, Germany.
Orell MielkeCSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.
PRIMA Trial Investigators and the PATH Study Group
CSL (United States) · US1 Military Clinical Hospital with Outpatient Clinic · PLAZ Sint-Lucas · BECedars-Sinai Medical Center · USHeinrich Heine University Düsseldorf · DEHelsinki University Hospital · FIJohns Hopkins University · USLeiden University Medical Center · NLNagoya University · JPPhilipps University of Marburg · DEPitié-Salpêtrière Hospital · FRSt. Elisabeth Hospital · CWUniversitair Ziekenhuis Leuven · BEUniversitätsklinikum Würzburg · DEUniversity of Amsterdam · NLUniversity of Toronto · CAWojewódzki Szpital Specjalistyczny we Wrocławiu · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Indexed as

Outcome Assessment, Health CareAdultAgedAged, 80 and overDouble-Blind MethodEuropeFemaleHumansImmunoglobulins, IntravenousImmunologic FactorsMaleMiddle AgedPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingProspective StudiesYoung AdultImmunoglobulins, IntravenousImmunologic FactorsCIDPefficacyIVIGPATHPRIMA

Identifiers

PMID30672091
PMCPMC6594229
OpenAlexW2914184511

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.