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      • Record: found
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      Effect of chondroitin sulfate on soluble biomarkers of osteoarthritis: a method to analyze and interpret the results from an open-label trial in unilateral knee osteoarthritis patients

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          Abstract

          Background

          The aim of this study was to investigate the effects of chondroitin sulfate (CS) on the serum levels of Coll2-1 in patients with knee OA.

          Methods

          Seventy two patients with unilateral symptomatic knee OA were involved in a post-authorization open-label study evaluating CS (800 mg/day). The primary outcome was the % relative change in serum Coll2-1 (sColl2-1). The secondary outcomes were the evaluation of pain (VAS) and function (Lequesne’s Index). Responders and non-responders were classified according to OMERACT-OARSI recommendations. Finally, an original cut-off method was applied to categorize patients and interpret individual variations in serum levels of Coll2-1.

          Results

          Patients showed no difference in the sColl2-1 levels at baseline. When considering responders and non-responders from the ITT population, a significant difference was found for Coll2-1 at 3 months ( p = 0.030) and 6 months ( p = 0.038). A decrease in pain (VAS) and an improvement in function (LI) were recorded throughout the visits ( p < 0.01). Considering an intra-batch cut-off of 21 %, CS decreased Coll2-1 serum levels between baseline and 1-month visit compared to the value of Coll2-1 before treatment (screening visit) which can be interpreted as a drastic reduction of the proportion of patients with an increase of Coll2-1 over 21 % (reduction from 13 to 3 %). It also consisted in a more important proportion of patients with a decrease in Coll2-1 (from 5 to 10 %).

          Conclusion

          This study proposes a new approach for the analysis and the interpretation of the individual variation in biomarker levels and introduces the notion of metabolic responders.

          Trial registration

          ID ISRCTN63795830. The trial was retrospectively registered on 2 October, 2015.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12891-016-1268-4) contains supplementary material, which is available to authorized users.

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          Most cited references15

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          Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis.

          V.B. Kraus, B Burnett, J Coindreau … (2011)
          Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal. The Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007 and 2009 at the behest of the Osteoarthritis Research Society International Federal Drug Administration initiative (OARSI FDA initiative). This document summarizes definitions and classification systems for biomarkers, the current outcome measures used in OA clinical trials, applications and potential utility of biomarkers for development of OA therapeutics, the current state of qualification of OA-related biomarkers, pathways for biomarker qualification, critical needs to advance the use of biomarkers for drug development, recommendations regarding practices and clinical trials, and a research agenda to advance the science of OA-related biomarkers. Although many OA-related biomarkers are currently available they exist in various states of qualification and validation. The biomarkers that are likely to have the earliest beneficial impact on clinical trials fall into two general categories, those that will allow targeting of subjects most likely to either respond and/or progress (prognostic value) within a reasonable and manageable time frame for a clinical study (for instance within 1-2 years for an OA trial), and those that provide early feedback for preclinical decision-making and for trial organizers that a drug is having the desired biochemical effect. As in vitro biomarkers are increasingly investigated in the context of specific drug treatments, advances in the field can be expected that will lead to rapid expansion of the list of available biomarkers with increasing understanding of the molecular processes that they represent. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
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            Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria.

            Annie S. Anderson, Désirée van der Heijde, Lee Simon … (2003)
            Improvement in analysis and reporting results of osteoarthritis (OA) clinical trials has been recently obtained because of harmonization and standardization of the selection of outcome variables (OMERACT 3 and OARSI). Moreover, OARSI has recently proposed the OARSI responder criteria. This composite index permits presentation of results of symptom modifying clinical trials in OA based on individual patient responses (responder yes/no). The 2 organizations (OMERACT and OARSI) established a task force aimed at evaluating: (1) the variability of observed placebo and active treatment effects using the OARSI responder criteria; and (2) the possibility of proposing a simplified set of criteria. The conclusions of the task force were presented and discussed during the OMERACT 6 conference, where a simplified set of responder criteria (OMERACT-OARSI set of criteria) was proposed.
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              Clinical aspects, pathology and pathophysiology of osteoarthritis.

              S R Goldring, M Goldring (2015)
              Article 0 comments Cited 46 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Ingrid Möller: ingrid.moller@ipoal.com
                Myriam Gharbi: myriam.gharbi@artialis.com
                Helena Martinez Serrano: hmartinez@bioiberica.com
                Marta Herrero Barbero: mherrero@bioiberica.com
                Josep Verges Milano: jverges@bioiberica.com
                Yves Henrotin: yhenrotin@ulg.ac.be
                Journal
                Journal ID (nlm-ta): BMC Musculoskelet Disord
                Journal ID (iso-abbrev): BMC Musculoskelet Disord
                Title: BMC Musculoskeletal Disorders
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2474
                Publication date (Electronic): 6 October 2016
                Publication date PMC-release: 6 October 2016
                Publication date Collection: 2016
                Volume: 17
                Electronic Location Identifier: 416
                Affiliations
                [1 ]Poal Institute of Rheumatology, Barcelona, Spain
                [2 ]Artialis SA, GIGA Tower, CHU Sart-Tilman, 4000 Liège, Belgium
                [3 ]Clinical R&D Area, Bioiberica S.A., Barcelona, Spain
                [4 ]Bone and Cartilage Research Unit, Arthropôle Liège, Institute of Pathology, University of Liège, level +5, CHU Sart-Tilman, 4000 Liège, Belgium
                Article
                Publisher ID: 1268
                DOI: 10.1186/s12891-016-1268-4
                PMC ID: 5053075
                PubMed ID: 27716158
                SO-VID: 1fd254cc-ff51-4dc1-988d-0e738ff554cc
                Copyright © © The Author(s). 2016
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 6 July 2016
                Date accepted : 24 September 2016
                Funding
                Funded by: Bioiberica SA
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2016

                ScienceOpen disciplines: Orthopedics
                Keywords: biomarkers,pain,osteoarthritis,chondroitin sulfate,cartilage metabolism
                Data availability:
                ScienceOpen disciplines: Orthopedics
                Keywords: biomarkers, pain, osteoarthritis, chondroitin sulfate, cartilage metabolism

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