The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value

Objective: The inflammatory endotype is arguably one of the most well-established endotype in osteoarthritis (OA). While endotyping holds promise for advancing drug development, numerous potential challenges must be considered, addressed and resolved before successful clinical outcomes can be achiev...

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Main Authors: Morten Asser Karsdal, Lucio C. Rovati, Jeyanesh Tambiah, Olga Kubassova, Christoph Ladel, Francis Berenbaum, Anne-Christine Bay-Jensen, Lachy Mclean, Richard Loeser, Ali Mobasheri, Virginia B. Kraus
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Osteoarthritis and Cartilage Open
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Online Access:http://www.sciencedirect.com/science/article/pii/S2665913125000081
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author Morten Asser Karsdal
Lucio C. Rovati
Jeyanesh Tambiah
Olga Kubassova
Christoph Ladel
Francis Berenbaum
Anne-Christine Bay-Jensen
Lachy Mclean
Richard Loeser
Ali Mobasheri
Virginia B. Kraus
author_facet Morten Asser Karsdal
Lucio C. Rovati
Jeyanesh Tambiah
Olga Kubassova
Christoph Ladel
Francis Berenbaum
Anne-Christine Bay-Jensen
Lachy Mclean
Richard Loeser
Ali Mobasheri
Virginia B. Kraus
author_sort Morten Asser Karsdal
collection DOAJ
description Objective: The inflammatory endotype is arguably one of the most well-established endotype in osteoarthritis (OA). While endotyping holds promise for advancing drug development, numerous potential challenges must be considered, addressed and resolved before successful clinical outcomes can be achieved. Design: Since 2017, the Osteoarthritis Research Society International (OARSI) has hosted the Clinical Trials Symposium (CTS). Each year, OARSI and the CTS steering committee encourage discussions on selected topics among a broad range of stakeholders, including regulators, drug developers, clinicians, clinical researchers, biomarker specialists, and basic scientists, with the aim of advancing drug development in the OA field. Results: This report highlights the ongoing tension between academia's “blue ocean” strategy and the feasibility-driven approach of drug developers, all within the context of scientific efforts to find effective solutions. Understanding the needs, goals, constraints, and opportunities of all involved stakeholders is crucial for defining optimal drug development strategies for OA. Conclusion: A multidisciplinary, collaborative approach is essential for developing effective OA treatments, balancing scientific discovery with regulatory and clinical feasibility.
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spelling doaj-art-1e21ebf7913846c4b6cc4c91c11af5092025-08-20T02:32:54ZengElsevierOsteoarthritis and Cartilage Open2665-91312025-06-017210057210.1016/j.ocarto.2025.100572The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high valueMorten Asser Karsdal0Lucio C. Rovati1Jeyanesh Tambiah2Olga Kubassova3Christoph Ladel4Francis Berenbaum5Anne-Christine Bay-Jensen6Lachy Mclean7Richard Loeser8Ali Mobasheri9Virginia B. Kraus10Nordic Bioscience, Herlev, Denmark; Corresponding author.Rottapharm Biotech, Monza, Italy; School of Medicine, University of Milano-Bicocca, ItalyBiosplice Therapeutics, 9360 Towne Center Drive, San Diego, CA, 92121,USAImage Analysis Group, London, United KingdomCHL4special Consulting, Meisenweg 3, 64291, Darmstadt, GermanyDepartment of Rheumatology, Sorbonne University, INSERM, AP-HP, Saint-Antoine Hospital, Paris, FranceNordic Bioscience, Herlev, DenmarkGenascence Corporation, 350 Cambridge Ave., Palo Alto, CA, 94306, USADivision of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina School of Medicine, Chapel Hill, NC, USAResearch Unit of Health Sciences and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Department of Joint Surgery, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China; Faculty of Medicine, Université de Liège, Liège, BelgiumDuke Molecular Physiology Institute and Department of Medicine, Duke University School of Medicine, Durham, NC, USAObjective: The inflammatory endotype is arguably one of the most well-established endotype in osteoarthritis (OA). While endotyping holds promise for advancing drug development, numerous potential challenges must be considered, addressed and resolved before successful clinical outcomes can be achieved. Design: Since 2017, the Osteoarthritis Research Society International (OARSI) has hosted the Clinical Trials Symposium (CTS). Each year, OARSI and the CTS steering committee encourage discussions on selected topics among a broad range of stakeholders, including regulators, drug developers, clinicians, clinical researchers, biomarker specialists, and basic scientists, with the aim of advancing drug development in the OA field. Results: This report highlights the ongoing tension between academia's “blue ocean” strategy and the feasibility-driven approach of drug developers, all within the context of scientific efforts to find effective solutions. Understanding the needs, goals, constraints, and opportunities of all involved stakeholders is crucial for defining optimal drug development strategies for OA. Conclusion: A multidisciplinary, collaborative approach is essential for developing effective OA treatments, balancing scientific discovery with regulatory and clinical feasibility.http://www.sciencedirect.com/science/article/pii/S2665913125000081OsteoarthritisStratificationClinical developmentInflammationPhenotypeEndotype
spellingShingle Morten Asser Karsdal
Lucio C. Rovati
Jeyanesh Tambiah
Olga Kubassova
Christoph Ladel
Francis Berenbaum
Anne-Christine Bay-Jensen
Lachy Mclean
Richard Loeser
Ali Mobasheri
Virginia B. Kraus
The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value
Osteoarthritis and Cartilage Open
Osteoarthritis
Stratification
Clinical development
Inflammation
Phenotype
Endotype
title The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value
title_full The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value
title_fullStr The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value
title_full_unstemmed The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value
title_short The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical developmentBiomarkers of high value
title_sort inflammatory endotype in osteoarthritis reflections from the 2024 oarsi clinical trials symposium cts with a special emphasis on feasibility for clinical developmentbiomarkers of high value
topic Osteoarthritis
Stratification
Clinical development
Inflammation
Phenotype
Endotype
url http://www.sciencedirect.com/science/article/pii/S2665913125000081
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