Evidence map›Paper›PMID 27354683›Full record

Trial reportRheumatology (Oxford, England)2016

Interferon α kinoid induces neutralizing anti-interferon α antibodies that decrease the expression of interferon-induced and B cell activation associated transcripts: analysis of extended follow-up data from the interferon α kinoid phase I/II study.

Julie Ducreux, Frédéric A Houssiau, Pierre Vandepapelière, Christian Jorgensen, Estibaliz Lazaro, François Spertini, Fabien Colaone, Camille Roucairol, Marion Laborie, Thérèse Croughs and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Rheumatology (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01058343 (A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.), which is not on this map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
11.1field-weighted citation impact, top 1% 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.

NCT01058343 phase1 / phase2completednot on this map

A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.

TypeinterventionalSponsorNeovacsRan2010 to 2016Enrolled28ConditionsSystemic Lupus ErythematosusArmsIFN-K
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 84 citations in OpenAlex.

  1. Article
  2. Review
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  4. Review
  5. Review
  6. Interferon Inhibition in SLE: From Bench to Bedside.Mediterranean journal of rheumatology · 2024
    Review
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  14. Review
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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

12 authors at 6 institutions in 3 countries.

Julie DucreuxInstitut de Recherche Expérimentale et Clinique, Pôle de pathologies rhumatismales inflammatoires et systémiques, Université catholique de Louvain.
Frédéric A HoussiauInstitut de Recherche Expérimentale et Clinique, Pôle de pathologies rhumatismales inflammatoires et systémiques, Université catholique de Louvain Département de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Pierre VandepapelièreNeovacs, Paris.
Christian JorgensenClinical Immunology and Therapeutic of Osteoarticular Diseases Unit, Department of Rheumatology, Hôpital Lapeyronie, Montpellier.
Estibaliz LazaroDepartment of Internal Medicine, Hôpital de Haut Levêque, CHU Bordeaux, Pessac, France.
François SpertiniDivision of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Fabien ColaoneNeovacs, Paris.
Camille RoucairolNeovacs, Paris.
Marion LaborieNeovacs, Paris.
Thérèse CroughsNeovacs, Paris.
Géraldine Grouard-VogelNeovacs, Paris gvogel@neovacs.com.
Bernard R LauwerysInstitut de Recherche Expérimentale et Clinique, Pôle de pathologies rhumatismales inflammatoires et systémiques, Université catholique de Louvain Département de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Neovacs (France) · FRUCLouvain · BECliniques Universitaires Saint-Luc · BEHôpital Cardiologique du Haut-Lévêque · FRHôpital Lapeyronie · FRUniversity Hospital of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIFN α Kinoid (IFN-K) is a therapeutic vaccine composed of IFNα2b coupled to a carrier protein. In a phase I/II placebo-controlled trial, we observed that IFN-K significantly decreases the IFN gene signature in whole blood RNA samples from SLE patients. Here, we analysed extended follow-up data from IFN-K-treated patients, in order to evaluate persistence of neutralizing anti-IFNα Abs antibodies (Abs), and gene expression profiling.

methodsSerum and whole blood RNA samples were obtained in IFN-K-treated patients included in the follow-up study, in order to determine binding and neutralizing anti-IFNα Ab titres, and perform high-throughput transcriptomic studies.

resultsNeutralization studies of 13 IFNα subtypes demonstrated the polyclonal nature of the Ab response induced by IFN-K. Follow-up analyses in six patients confirmed a significant correlation between neutralizing anti-IFNα Ab titres and decrease in IFN scores compared to baseline. These analyses also revealed an inhibitory effect of IFNα blockade on the expression of B cell associated transcripts.

conclusionsIFN-K induces a polyclonal anti-IFNα response that decreases IFN- and B cell-associated transcripts.

trial registrationClinicalTrials.gov, clinicaltrials.gov, NCT01058343.

Indexed as

AdolescentAdultAntibodies, NeutralizingAnti-Inflammatory AgentsB-LymphocytesDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansInterferon-alphaInterferon alpha-2Lupus Erythematosus, SystemicLymphocyte ActivationMaleMiddle AgedAntibodies, NeutralizingAnti-Inflammatory AgentsInterferon-alphaInterferon alpha-2Recombinant ProteinsB cellsinterferon alphainterferon alpha kinoidinterferon signaturesystemic lupus erythematosus

Identifiers

PMID27354683
PMCPMC5034220
OpenAlexW2464998826

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.