Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis

Objective To identify blood-based predictive and pharmacodynamic biomarkers at different timepoints in patients with active rheumatoid arthritis (RA) treated with anti-interleukin-6 receptor (anti-IL-6R) and anti-tumour necrosis factor-α (anti-TNF-α).Methods This study used blood samples from the MO...

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Main Authors: Emilie Gerard, Michel Didier, Matthias Herrmann, Inoncent Agueusop, Daniel Margerie, Anne Remaury, Raphaël Brard, Francesca Frau, Gilbert Thill, Yaligara Veeranagouda, Markus Kohlmann, Nadine Biesemann
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Language:English
Published: BMJ Publishing Group 2025-08-01
Series:RMD Open
Online Access:https://rmdopen.bmj.com/content/11/3/e005556.full
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author Emilie Gerard
Michel Didier
Matthias Herrmann
Inoncent Agueusop
Daniel Margerie
Anne Remaury
Raphaël Brard
Francesca Frau
Gilbert Thill
Yaligara Veeranagouda
Markus Kohlmann
Nadine Biesemann
author_facet Emilie Gerard
Michel Didier
Matthias Herrmann
Inoncent Agueusop
Daniel Margerie
Anne Remaury
Raphaël Brard
Francesca Frau
Gilbert Thill
Yaligara Veeranagouda
Markus Kohlmann
Nadine Biesemann
author_sort Emilie Gerard
collection DOAJ
description Objective To identify blood-based predictive and pharmacodynamic biomarkers at different timepoints in patients with active rheumatoid arthritis (RA) treated with anti-interleukin-6 receptor (anti-IL-6R) and anti-tumour necrosis factor-α (anti-TNF-α).Methods This study used blood samples from the MONARCH trial (NCT02332590), a randomised, double-blind, phase III trial that compared the safety and efficacy of sarilumab (anti-IL-6R) and adalimumab (anti-TNF-α) monotherapy in patients with RA who were intolerant/inadequate responders to methotrexate. The study evaluated predictive biomarkers to anti-IL-6R and anti-TNF-α treatments at baseline and week 2 and pharmacodynamic biomarkers at week 2 and week 24 using Olink proteomics analysis (n=804 serum samples from 268 patients). Change in gene expression levels (n=522 peripheral blood samples from 261 patients) by both treatments was assessed using RNA sequencing analysis.Results Serum biomarkers most predictive to anti-IL-6R were different from those of anti-TNF-α; predictive biomarkers for anti-IL-6R were correlated with innate immune activation and synovial inflammation, while predictive biomarkers for anti-TNF-α seemed to be more T-cell and neutrophil-related. For baseline predictive biomarkers, we had to focus on relative prediction as the absolute prediction performance of single and combination biomarkers using cross-validation was limited. Additionally, the pharmacodynamic effects of anti-IL-6R and anti-TNF-α on biomarkers as well as pathway signatures were distinct.Conclusion The unbiased analysis of serum proteins identified biomarkers most predictive of anti-IL-6R and anti-TNF-α at different timepoints that could explain the difference in the response rate in patients with RA. Further, both biomarker and pathway results highlighted a differentiated mode of action of both treatments.
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spelling doaj-art-6a7681035888433fbae41a89af93b6832025-08-20T03:59:31ZengBMJ Publishing GroupRMD Open2056-59332025-08-0111310.1136/rmdopen-2025-005556Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysisEmilie Gerard0Michel Didier1Matthias Herrmann2Inoncent Agueusop3Daniel Margerie4Anne Remaury5Raphaël Brard6Francesca Frau7Gilbert Thill8Yaligara Veeranagouda9Markus Kohlmann10Nadine Biesemann11Sanofi, Randomised Clinical Trials and Post Hoc Analyses Team, Gentilly, FranceSanofi R&D, Translational Sciences, Chilly-Mazarin, FranceSanofi R&D, Immunology and Inflammation Therapeutic Area, Type 1/17 Immunology Cluster, Industriepark Hoechst, Frankfurt am Main, GermanySanofi R&D, Biostatistics, Industriepark Hoechst, Frankfurt am Main, GermanySanofi R&D, Digital and Data Science, Industriepark Hoechst, Frankfurt am Main, GermanySanofi R&D, Translational Sciences, Chilly-Mazarin, FranceSanofi R&D, Biostatistics, Industriepark Hoechst, Frankfurt am Main, GermanySanofi R&D, Digital and Data Science, Industriepark Hoechst, Frankfurt am Main, GermanySanofi R&D, Translational Sciences, Chilly-Mazarin, FranceSanofi R&D, Translational Sciences, Chilly-Mazarin, FranceSanofi R&D, Early Clinical Development Therapeutic Area Immunology and Inflammation, Industriepark Hoechst, Frankfurt am Main, GermanySanofi R&D, Immunology and Inflammation Therapeutic Area, Type 1/17 Immunology Cluster, Industriepark Hoechst, Frankfurt am Main, GermanyObjective To identify blood-based predictive and pharmacodynamic biomarkers at different timepoints in patients with active rheumatoid arthritis (RA) treated with anti-interleukin-6 receptor (anti-IL-6R) and anti-tumour necrosis factor-α (anti-TNF-α).Methods This study used blood samples from the MONARCH trial (NCT02332590), a randomised, double-blind, phase III trial that compared the safety and efficacy of sarilumab (anti-IL-6R) and adalimumab (anti-TNF-α) monotherapy in patients with RA who were intolerant/inadequate responders to methotrexate. The study evaluated predictive biomarkers to anti-IL-6R and anti-TNF-α treatments at baseline and week 2 and pharmacodynamic biomarkers at week 2 and week 24 using Olink proteomics analysis (n=804 serum samples from 268 patients). Change in gene expression levels (n=522 peripheral blood samples from 261 patients) by both treatments was assessed using RNA sequencing analysis.Results Serum biomarkers most predictive to anti-IL-6R were different from those of anti-TNF-α; predictive biomarkers for anti-IL-6R were correlated with innate immune activation and synovial inflammation, while predictive biomarkers for anti-TNF-α seemed to be more T-cell and neutrophil-related. For baseline predictive biomarkers, we had to focus on relative prediction as the absolute prediction performance of single and combination biomarkers using cross-validation was limited. Additionally, the pharmacodynamic effects of anti-IL-6R and anti-TNF-α on biomarkers as well as pathway signatures were distinct.Conclusion The unbiased analysis of serum proteins identified biomarkers most predictive of anti-IL-6R and anti-TNF-α at different timepoints that could explain the difference in the response rate in patients with RA. Further, both biomarker and pathway results highlighted a differentiated mode of action of both treatments.https://rmdopen.bmj.com/content/11/3/e005556.full
spellingShingle Emilie Gerard
Michel Didier
Matthias Herrmann
Inoncent Agueusop
Daniel Margerie
Anne Remaury
Raphaël Brard
Francesca Frau
Gilbert Thill
Yaligara Veeranagouda
Markus Kohlmann
Nadine Biesemann
Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis
RMD Open
title Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis
title_full Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis
title_fullStr Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis
title_full_unstemmed Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis
title_short Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysis
title_sort deciphering differential biomarkers for anti interleukin 6 receptor and anti tumour necrosis factor α treatment response in rheumatoid arthritis by multiomics analysis
url https://rmdopen.bmj.com/content/11/3/e005556.full
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