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7. Longitudinal stability of molecular endotypes of knee osteoarthritis patients

Author

Hannani, Monica T., Thudium, Christian S., Gellhorn, Alfred C., Larkin, Jonathan, Karsdal, Morten A., Lisowska-Petersen, Zofia, Frederiksen, Peder, Bager, Cecilie L., Ladel, Christoph, Struglics, André, Uebelhoer, Melanie, Henrotin, Yves, Bihlet, Asger R., Blanco, Francisco J., Haugen, Ida K., Kloppenburg, Margreet, Berenbaum, Francis, Mobasheri, Ali, Bacardit, Jaume, and Bay-Jensen, Anne-Christine

Published
2025
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16. Future detection and monitoring of diabetes may entail analysis of both β-cell function and volume: How markers of β-cell loss may assist

Author

Neutzsky-Wulff Anita V, Andreassen Kim V, Hjuler Sara T, Feigh Michael, Bay-Jensen Anne-Christine, Zheng Qinlong, Henriksen Kim, and Karsdal Morten A

Subjects
Neo-epitope, Biomarkers, Type II diabetes mellitus, β-cell death, BIPED classification, Patient segregation, Personalized treatment, Medicine
Abstract

Abstract Disease heterogeneity is as major issue in Type II Diabetes Mellitus (T2DM), and this patient inter-variability might not be sufficiently reflected by measurements of glycated haemoglobin (HbA1c). Β-cell dysfunction and β-cell death are initiating factors in development of T2DM. In fact, β-cells are known vanish prior to the development of T2DM, and autopsy of overt T2DM patients have shown a 60% reduction in β-cell mass. As the decline in β-cell function and mass have been proven to be pathological traits in T2DM, methods for evaluating β-cell loss is becoming of more interest. However, evaluation of β-cell death or loss is currently invasive and unattainable for the vast majority of diabetes patients. Serological markers, reflecting β-cell loss would be advantageous to detect and monitor progression of T2DM. Biomarkers with such capacities could be neo-epitopes of proteins with high β-cell specificity containing post translational modifications. Such tools may segregate T2DM patients into more appropriate treatment groups, based on their β-cell status, which is currently not possible. Presently individuals presenting with adequately elevated levels of both insulin and glucose are classified as T2DM patients, while an important subdivision of those is pending, namely those patients with sufficient β-cell capacity and those without. This may warrant two very different treatment options and patient care paths. Serological biomarkers reflecting β-cell health status may also assist development of new drugs for T2DM and aid physicians in better characterization of individual patients and tailor individual treatments and patient care protocols.

Published
2012
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17. Investigation of the direct effects of salmon calcitonin on human osteoarthritic chondrocytes

Author

Pedersen Christian, Christiansen Thorbjorn, Paulsen Sarah J, Segovia-Silvestre Toni, Madsen Suzi H, Sondergaard Bodil-Cecilie, Bay-Jensen Anne-Christine, and Karsdal Morten A

Subjects
Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract Background Calcitonin has been demonstrated to have chondroprotective effects under pre-clinical settings. It is debated whether this effect is mediated through subchondral-bone, directly on cartilage or both in combination. We investigated possible direct effects of salmon calcitonin on proteoglycans and collagen-type-II synthesis in osteoarthritic (OA) cartilage. Methods Human OA cartilage explants were cultured with salmon calcitonin [100 pM-100 nM]. Direct effects of calcitonin on articular cartilage were evaluated by 1) measurement of proteoglycan synthesis by incorporation of radioactive labeled 35SO4 [5 μCi] 2) quantification of collagen-type-II formation by pro-peptides of collagen type II (PIINP) ELISA, 3) QPCR expression of the calcitonin receptor in OA chondrocytes using four individual primer pairs, 4) activation of the cAMP signaling pathway by EIA and, 5) investigations of metabolic activity by AlamarBlue. Results QPCR analysis and subsequent sequencing confirmed expression of the calcitonin receptor in human chondrocytes. All doses of salmon calcitonin significantly elevated cAMP levels (P < 0.01 and P < 0.001). Calcitonin significantly and concentration-dependently [100 pM-100 nM] induced proteoglycan synthesis measured by radioactive 35SO4 incorporation, with a 96% maximal induction at 10 nM (P < 0.001) corresponding to an 80% induction of 100 ng/ml IGF, (P < 0.05). In alignment with calcitonin treatments [100 pM-100 nM] resulted in 35% (P < 0.01) increased PIINP levels. Conclusion Calcitonin treatment increased proteoglycan and collagen synthesis in human OA cartilage. In addition to its well-established effect on subchondral bone, calcitonin may prove beneficial to the management of joint diseases through direct effects on chondrocytes.

Published
2010
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18. Development and validation of a machine learning-supported strategy of patient selection for osteoarthritis clinical trials: the IMI-APPROACH study

Author

Widera, Paweł, Welsing, Paco M.J., Danso, Samuel O., Peelen, Sjaak, Kloppenburg, Margreet, Loef, Marieke, Marijnissen, Anne C., van Helvoort, Eefje M., Blanco, Francisco J., Magalhães, Joana, Berenbaum, Francis, Haugen, Ida K., Bay-Jensen, Anne-Christine, Mobasheri, Ali, Ladel, Christoph, Loughlin, John, Lafeber, Floris P.J.G., Lalande, Agnès, Larkin, Jonathan, Weinans, Harrie, and Bacardit, Jaume

Published
2023
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19. Biomarker of extracellular matrix remodelling C1M and proinflammatory cytokine IL-6 are related to synovitis and pain in end-stage knee osteoarthritis patients

Author

Radojcic, Maja R., Thudium, Christian S., Henriksen, Kim, Tan, Keith, Karlsten, Rolf, Dudley, Amanda, Chessell, Iain, Karsdal, Morten A., Bay-Jensen, Anne-Christine, Crema, Michel D., and Guermazi, Ali

Subjects
Quantitative Biology - Tissues and Organs
Abstract

Little is known about local and systemic biomarkers in relation to synovitis and pain in end-stage osteoarthritis (OA) patients. We investigated the associations between the novel extracellular matrix biomarker, C1M, and local and systemic interleukin 6 (IL-6) with synovitis and pain. Serum C1M, plasma and synovial fluid IL-6 (p-IL-6, sf-IL-6) were measured in 104 end-stage knee OA patients. Contrast-enhanced magnetic resonance imaging (MRI) was used to semi-quantitatively assess an 11-point synovitis score; pain was assessed by the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) and the Neuropathic Pain Questionnaire (NPQ). Linear regression was used to investigate associations between biomarkers and synovitis, and biomarkers and pain while controlling for age, sex and body mass index. We also tested whether associations between biomarkers and pain were confounded by synovitis. We found sf-IL-6 was associated with synovitis in the parapatellar subregion (B=0.006; 95% CI 0.003-0.010), and no association between p-IL-6 and synovitis. We also observed an association between C1M and synovitis in the peri-ligamentous subregion (B=0.013; 95% CI 0.003-0.023). Further, sf-IL-6, but not p-IL-6, was significantly associated with pain, WOMAC (B=0.022; 95% CI 0.004-0.040) and NPQ (B=0.043;95% CI 0.005-0.082). There was no association between C1M and WOMAC pain but we did find an association between C1M and NPQ (B=0.229; 95% CI 0.036-0.422). Lastly, synovitis explained both biomarker-NPQ associations, but not the biomarker-WOMAC association. These results suggest C1M and IL-6 are associated with synovitis and pain, and synovitis is an important confounding variable when studying biomarkers and neuropathic features in OA patients., Comment: 19 pages, 2 figures, 5 tables and 2 supplementary figures

Published
2019
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20. Serum Biomarkers for Connective Tissue and Basement Membrane Remodeling are Associated with Vertebral Endplate Bone Marrow Lesions as Seen on MRI (Modic Changes).

Author

Dudli, Stefan, Ballatori, Alexander, Bay-Jensen, Anne-Christine, McCormick, Zachary L, O'Neill, Conor W, Demir-Deviren, Sibel, Krug, Roland, Heggli, Irina, Juengel, Astrid, Karppinen, Jaro, Brunner, Florian, Farshad, Mazda, Distler, Oliver, Lotz, Jeffrey C, and Fields, Aaron J

Subjects
Lumbar Vertebrae, Connective Tissue, Basement Membrane, Bone Marrow, Humans, Back Pain, Magnetic Resonance Imaging, Adult, Middle Aged, Female, Male, Biomarkers, Modic change, basement membrane, biomarker, bone marrow, connective tissue, disc degeneration, low back pain, Chemical Physics, Other Chemical Sciences, Genetics, Other Biological Sciences
Abstract

Vertebral endplate bone marrow lesions, visualized on magnetic resonance imaging (MRI) as Modic changes (MC), are associated with chronic low back pain (cLBP). Since guidelines recommend against routine spinal MRI for cLBP in primary care, MC may be underdiagnosed. Serum biomarkers for MC would allow early diagnosis, inform clinical care decisions, and supplement treatment monitoring. We aimed to discover biomarkers in the blood serum that correlate with MC pathophysiological processes. For this single-site cross-sectional study, we recruited 54 subjects with 38 cLBP patients and 16 volunteers without a history of LBP. All subjects completed an Oswestry Disability Index (ODI) questionnaire and 10-cm Visual Analog Score (VAS) for LBP (VASback) and leg pain. Lumbar T1-weighted and fat-saturated T2-weighted MRI were acquired at 3T and used for MC classification in each endplate. Blood serum was collected on the day of MRI. Biomarkers related to disc resorption and bone marrow fibrosis were analyzed with enzyme-linked immune-absorbent assays. The concentration of biomarkers between no MC and any type of MC (AnyMC), MC1, and MC2 were compared. The Area Under the Curve (AUC) of the Receiver Operating Characteristics were calculated for each biomarker and for bivariable biomarker models. We found that biomarkers related to type III and type IV collagen degradation and formation tended to correlate with the presence of MC (p = 0.060-0.088). The bivariable model with the highest AUC was PRO-C3 + C4M and had a moderate diagnostic value for AnyMC in cLBP patients (AUC = 0.73, specificity = 78.9%, sensitivity = 73.7%). In conclusion, serum biomarkers related to the formation and degradation of type III and type IV collagen, which are key molecules in bone marrow fibrosis, correlated with MC presence. Bone marrow fibrosis may be an important pathophysiological process in MC that should be targeted in larger biomarker and treatment studies.

Published
2020

25. Diagnostic potential of blood-based biomarkers in multiple sclerosis.

Author

Holm Nielsen, Signe, Karsdal, Morten, Manoel, Bruna, Bay-Jensen, Anne-Christine, and Henriksen, Kim

Subjects
PEPTIDE mass fingerprinting, CENTRAL nervous system diseases, DELAYED diagnosis, MATRIX metalloproteinases, MULTIPLE sclerosis
Abstract

Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system (CNS). There is a significant delay in diagnosing MS as the symptoms and tests overlap with other diseases. Blood-based biomarkers, which quantify fragments of proteins involved in MS pathophysiology, have the potential as diagnostic biomarkers. In this study, we evaluated biomarkers by immunoassays, of tissue destruction, reflected by biglycan degraded by matrix metalloproteinases (MMPs) (BGM), cathepsin S-degraded nidogen (NIC), and MMP-degraded secreted protein acidic and rich in cysteine (SPARC-M) in healthy donors and patients diagnosed with MS. The biomarkers were able to separate the two groups with an AUC = 0.710, AUC = 0.765, and AUC = 0.875, respectively. These pathologically released protein fragments could potentially be used as biomarkers in clinical management providing a specific protein fingerprint. [ABSTRACT FROM AUTHOR]

Published
2025
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35. Type IX Collagen Turnover Is Altered in Patients with Solid Tumors

Author

Port, Helena, He, Yi, Karsdal, Morten A., Madsen, Emilie A., Bay-Jensen, Anne Christine, Willumsen, Nicholas, Holm Nielsen, Signe, Port, Helena, He, Yi, Karsdal, Morten A., Madsen, Emilie A., Bay-Jensen, Anne Christine, Willumsen, Nicholas, and Holm Nielsen, Signe

Abstract

The fibrotic tumor microenvironment, characterized by its intricate extracellular matrix (ECM), consists of many collagens with diverse functions and unexplored biomarker potential. Type IX collagen is a member of the low-abundance collagen family known as the fibril-associated collagen with interrupted triple helices (FACITs) and is found mostly in cartilage. Its role in the tumor microenvironment remains unexplored. To investigate the biomarker potential of a type IX collagen in cancer, an immuno-assay was developed (PRO-C9) and technical assay performance was evaluated for the assessment of serum. PRO-C9 levels were measured in serum samples from 259 patients with various solid tumor types compared to serum levels from 73 healthy controls. PRO-C9 levels were significantly elevated in patients with solid tumors including bladder, breast, colorectal, gastric, head and neck, lung, melanoma, ovarian, pancreatic, and renal compared to levels in healthy controls (p < 0.05–p < 0.0001). PRO-C9 could discriminate between patients with cancer and healthy controls, with the area under the receiver operating characteristic values ranging from 0.58 to 0.86 (p < 0.3–p < 0.0001), indicating potential diagnostic utility. This study suggests that type IX collagen turnover is altered in patients with solid tumors and demonstrates the feasibility of using PRO-C9 as a non-invasive serum-based biomarker with relevance in multiple cancer types. Furthermore, these results underscore the potential utility of PRO-C9 to better elucidate the biology of FACITs in cancers.

Published
2024

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Author

Groen, Solveig Skovlund, Bay-Jensen, Anne Christine, Thudium, Christian S., Dziegiel, Morten H., Skougaard, Marie, Thomsen, Simon Francis, Nielsen, Signe Holm, Groen, Solveig Skovlund, Bay-Jensen, Anne Christine, Thudium, Christian S., Dziegiel, Morten H., Skougaard, Marie, Thomsen, Simon Francis, and Nielsen, Signe Holm

Published
2024

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Author

Groen, Solveig Skovlund, Bay-Jensen, Anne-Christine, Thudium, Christian S., Dziegiel, Morten H., Skougaard, Marie, Thomsen, Simon Francis, Nielsen, Signe Holm, Groen, Solveig Skovlund, Bay-Jensen, Anne-Christine, Thudium, Christian S., Dziegiel, Morten H., Skougaard, Marie, Thomsen, Simon Francis, and Nielsen, Signe Holm

Published
2024

38. From biochemical markers to molecular endotypes of osteoarthritis:a review on validated biomarkers

Author

Hannani, Monica T., Thudium, Christian S., Karsdal, Morten A., Ladel, Christoph, Mobasheri, Ali, Uebelhoer, Melanie, Larkin, Jonathan, Bacardit, Jaume, Struglics, André, Bay-Jensen, Anne Christine, Hannani, Monica T., Thudium, Christian S., Karsdal, Morten A., Ladel, Christoph, Mobasheri, Ali, Uebelhoer, Melanie, Larkin, Jonathan, Bacardit, Jaume, Struglics, André, and Bay-Jensen, Anne Christine

Abstract

Introduction: Osteoarthritis (OA) affects over 500 million people worldwide. OA patients are symptomatically treated, and current therapies exhibit marginal efficacy and frequently carry safety-risks associated with chronic use. No disease-modifying therapies have been approved to date leaving surgical joint replacement as a last resort. To enable effective patient care and successful drug development there is an urgent need to uncover the pathobiological drivers of OA and how these translate into disease endotypes. Endotypes provide a more precise and mechanistic definition of disease subgroups than observable phenotypes, and a panel of tissue- and pathology-specific biochemical markers may uncover treatable endotypes of OA. Areas covered: We have searched PubMed for full-text articles written in English to provide an in-depth narrative review of a panel of validated biochemical markers utilized for endotyping of OA and their association to key OA pathologies. Expert opinion: As utilized in IMI-APPROACH and validated in OAI-FNIH, a panel of biochemical markers may uncover disease subgroups and facilitate the enrichment of treatable molecular endotypes for recruitment in therapeutic clinical trials. Understanding the link between biochemical markers and patient-reported outcomes and treatable endotypes that may respond to given therapies will pave the way for new drug development in OA.

Published
2024

48. Safety, Tolerability, and Pharmacodynamics of the ADAMTS‐5 Nanobody M6495: Two Phase 1, Single‐Center, Double‐Blind, Randomized, Placebo‐Controlled Studies in Healthy Subjects and Patients With Osteoarthritis

Author

Bihlet, Asger Reinstrup, primary, Balchen, Torben, additional, Goteti, Kosalaram, additional, Sonne, Jesper, additional, Ladel, Christoph, additional, Karsdal, Morten Asser, additional, Ona, Victor, additional, Moreau, Flavie, additional, Waterhouse, Roseann, additional, Bay‐Jensen, Anne‐Christine, additional, and Guehring, Hans, additional

Published
2024
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