Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways

ObjectiveTo characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.MethodsIn a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and anal...

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Published inLupus Science & Medicine Vol. 7; no. 1; p. e000424
Main Authors Dörner, Thomas, Tanaka, Yoshiya, Petri, Michelle A, Smolen, Josef S, Wallace, Daniel J, Dow, Ernst R, Higgs, Richard E, Rocha, Guilherme, Crowe, Brenda, Benschop, Robert J, Byers, Nicole L, Silk, Maria E, de Bono, Stephanie, Fantini, Damiano, Hoffman, Robert W
Format Journal Article
LanguageEnglish
Published England Lupus Foundation of America 01.10.2020
BMJ
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesOriginal research
Subjects
Adult
Arthritis
autoimmune diseases
Azetidines
Azetidines - therapeutic use
Clinical trials
Clinical Trials and Drug Discovery
Cytokines
Drug dosages
Female
Gene Expression
Humans
Immunologic diseases. Allergy
Kinases
Lupus
lupus erythematosus
Lupus Erythematosus, Systemic
Lupus Erythematosus, Systemic - drug therapy
Male
Middle Aged
Pathogenesis
Patients
Purines
Purines - therapeutic use
Pyrazoles
Pyrazoles - therapeutic use
RC581-607
Sulfonamides
Sulfonamides - therapeutic use
systemic
therapeutics
autoimmune diseases
systemic
therapeutics
cytokines
lupus erythematosus
Online AccessGet full text

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Abstract ObjectiveTo characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.MethodsIn a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.ResultsGene expression profiling demonstrated an elevation of STAT1, STAT2 and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including STAT1-target, STAT2-target and STAT4-target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.ConclusionBaricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.
AbstractList ObjectiveTo characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.MethodsIn a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.ResultsGene expression profiling demonstrated an elevation of STAT1, STAT2 and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including STAT1-target, STAT2-target and STAT4-target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.ConclusionBaricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.
Objective To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.Methods In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.Results Gene expression profiling demonstrated an elevation of STAT1, STAT2 and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including STAT1-target, STAT2-target and STAT4-target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.Conclusion Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.
To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE. In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays. Gene expression profiling demonstrated an elevation of , and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including -target, -target and target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24. Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.
To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.OBJECTIVETo characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.METHODSIn a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.Gene expression profiling demonstrated an elevation of STAT1, STAT2 and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including STAT1-target, STAT2-target and STAT4-target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.RESULTSGene expression profiling demonstrated an elevation of STAT1, STAT2 and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including STAT1-target, STAT2-target and STAT4-target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.CONCLUSIONBaricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.
Author Higgs, Richard E
Rocha, Guilherme
Fantini, Damiano
Byers, Nicole L
Wallace, Daniel J
Tanaka, Yoshiya
Smolen, Josef S
Hoffman, Robert W
Dow, Ernst R
Dörner, Thomas
de Bono, Stephanie
Silk, Maria E
Benschop, Robert J
Crowe, Brenda
Petri, Michelle A
AuthorAffiliation 1 DRFZ Berlin and Department of Rheumatology and Clinical Immunology , Charite University Hospital Berlin , Berlin , Germany
2 The First Department of Internal Medicine, School of Medicine , University of Occupational & Environmental Health , Kitakyushu , Japan
6 Eli Lilly and Company , Indianapolis , Indiana , USA
5 Department of Rheumatology , Cedars-Sinai Medical Center , West Hollywood , California , USA
4 Division of Rheumatology , Medical University of Vienna , Wien , Austria
3 Division of Rheumatology , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA
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Issue 1
Keywords autoimmune diseases
systemic
therapeutics
cytokines
lupus erythematosus
Language English
License This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
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SSID ssj0001213780
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Snippet ObjectiveTo characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in...
To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE. In a phase II,...
To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.OBJECTIVETo...
Objective To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in...
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pubmed
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nii
bmj
SourceType Open Website
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StartPage e000424
SubjectTerms Adult
Arthritis
autoimmune diseases
Azetidines
Azetidines - therapeutic use
Clinical trials
Clinical Trials and Drug Discovery
Cytokines
Drug dosages
Female
Gene Expression
Humans
Immunologic diseases. Allergy
Kinases
Lupus
lupus erythematosus
Lupus Erythematosus, Systemic
Lupus Erythematosus, Systemic - drug therapy
Male
Middle Aged
Pathogenesis
Patients
Purines
Purines - therapeutic use
Pyrazoles
Pyrazoles - therapeutic use
RC581-607
Sulfonamides
Sulfonamides - therapeutic use
systemic
therapeutics
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Title Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways
URI https://lupus.bmj.com/content/7/1/e000424.full
https://cir.nii.ac.jp/crid/1873116917952979840
https://www.ncbi.nlm.nih.gov/pubmed/33037080
https://www.proquest.com/docview/2449619562
https://www.proquest.com/docview/2449960434
https://pubmed.ncbi.nlm.nih.gov/PMC7549481
https://doaj.org/article/e5cc766cafc64ce9bf61c760b2589fcd
Volume 7
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