Frances Humby1, Stephen Kelly1, Serena Bugatti1, Antonio Manzo1, Andrew Filer1, Arti Mahto1, Joao Eurico Fonseca1, Bernard Lauwerys1, Maria-Antonietta D'Agostino1, Esperanza Naredo1, Rik Lories1, Carlomaurizio Montecucco1, Paul Peter Tak1, Oliver Fitzgerald1, Malcolm D Smith1, Douglas J Veale1, Ernest H Choy1, Vibeke Strand1, Costantino Pitzalis1. 1. From the Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute at Barts, and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Rheumatology and Translational Immunology Research Laboratories (LaRIT), Division of Rheumatology, IRCCS Policlinico San Matteo Foundation/University of Pavia, Pavia, Italy; Rheumatology Research Group, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, and Rheumatology Department, Lisbon Academic Medical Centre, Lisbon, Portugal; Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Department of Rheumatology, Cliniques Universitaires Saint-Luc, Brussels, Belgium; Rheumatology Department, Ambroise Paré Hospital, APHP, Université Versailles Saint Quentin en Yvelines, Inserm U987, Boulogne-Billancourt, France; Rheumatology Department, Hospital Universitario Severo Ochoa, Madrid, Spain; Laboratory for Skeletal Development and Joint Disorders, Department of Development and Regeneration, KU Leuven, Leuven, Belgium; University of Cambridge, Cambridge, UK; GlaxoSmithKline Research and Development, Stevenage, UK; School of Medicine and Medical Science, St. Vincent's University Hospital, Dublin, Ireland; Rheumatology Research Unit, Repatriation General Hospital, Daw Park, South Australia; Dublin Academic Medical Centre, The Conway Institute of Biomedical and Biomolecular Research, University College Dublin, Dublin, Ireland; Cardiff Institute of Infection and Immunity, Cardiff Regional Experimental Arthritis Treatment and Evaluation Centre, Cardiff, UK; Division of Immunology/Rheumatology, Stanford University School of Medicine, Stanford, California, USA.F. Humby, MRCP; S. Kelly, MRCP, Centre for Experimental Medicine and Rheumatology, William Harvey Research Ins
Abstract
OBJECTIVE: Because limited data currently support the clinical utility of peripherally expressed biomarkers in guiding treatment decisions for patients with rheumatoid arthritis, the search has turned to the disease tissue. The strategic aim of the Outcome Measures in Rheumatology (OMERACT) synovitis working group over the years has been to develop novel diagnostic and prognostic synovial biomarkers. A critical step in this process is to refine and validate minimally invasive, technically simple, robust techniques to sample synovial tissue, for use both in clinical trials and routine clinical practice. The objective of the synovitis working group (SWG) at OMERACT 12 (2014) was to examine whether recently developed ultrasound (US)-guided synovial biopsy techniques could be validated according to the OMERACT filter for future clinical use recommendation. METHODS: The SWG examined whether current data reporting US-guided synovial biopsy of both large and small joints addressed the OMERACT filters of truth, discrimination, and feasibility. RESULTS: There are currently limited data examining the performance of US-guided synovial biopsy, mainly from observational studies. Thus, it remains critical to evaluate its performance, within the clinical trials context, against the current gold standard of arthroscopic biopsy, with particular reference to: (1) synovial tissue yield, (2) capacity to determine treatment response as measured by a validated synovial biomarker, and (3) tolerability of the procedure. CONCLUSION: We summarize the discrete work packages agreed to as requirements to validate US-guided synovial biopsy and therefore lead to a global consensus on the use of synovial biopsy for research and clinical practice.
OBJECTIVE: Because limited data currently support the clinical utility of peripherally expressed biomarkers in guiding treatment decisions for patients with rheumatoid arthritis, the search has turned to the disease tissue. The strategic aim of the Outcome Measures in Rheumatology (OMERACT) synovitis working group over the years has been to develop novel diagnostic and prognostic synovial biomarkers. A critical step in this process is to refine and validate minimally invasive, technically simple, robust techniques to sample synovial tissue, for use both in clinical trials and routine clinical practice. The objective of the synovitis working group (SWG) at OMERACT 12 (2014) was to examine whether recently developed ultrasound (US)-guided synovial biopsy techniques could be validated according to the OMERACT filter for future clinical use recommendation. METHODS: The SWG examined whether current data reporting US-guided synovial biopsy of both large and small joints addressed the OMERACT filters of truth, discrimination, and feasibility. RESULTS: There are currently limited data examining the performance of US-guided synovial biopsy, mainly from observational studies. Thus, it remains critical to evaluate its performance, within the clinical trials context, against the current gold standard of arthroscopic biopsy, with particular reference to: (1) synovial tissue yield, (2) capacity to determine treatment response as measured by a validated synovial biomarker, and (3) tolerability of the procedure. CONCLUSION: We summarize the discrete work packages agreed to as requirements to validate US-guided synovial biopsy and therefore lead to a global consensus on the use of synovial biopsy for research and clinical practice.
Authors: Arthur M Mandelin; Philip J Homan; Alexander M Shaffer; Carla M Cuda; Salina T Dominguez; Emily Bacalao; Mary Carns; Monique Hinchcliff; Jungwha Lee; Kathleen Aren; Anjali Thakrar; Anna B Montgomery; S Louis Bridges; Joan M Bathon; John P Atkinson; David A Fox; Eric L Matteson; Christopher D Buckley; Costantino Pitzalis; Deborah Parks; Laura B Hughes; Laura Geraldino-Pardilla; Robert Ike; Kristine Phillips; Kerry Wright; Andrew Filer; Stephen Kelly; Eric M Ruderman; Vince Morgan; Hiam Abdala-Valencia; Alexander V Misharin; G Scott Budinger; Elizabeth T Bartom; Richard M Pope; Harris Perlman; Deborah R Winter Journal: Arthritis Rheumatol Date: 2018-05-03 Impact factor: 10.995
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Authors: F Rivellese; F Humby; S Bugatti; L Fossati-Jimack; H Rizvi; D Lucchesi; G Lliso-Ribera; A Nerviani; R E Hands; G Giorli; B Frias; G Thorborn; E Jaworska; C John; K Goldmann; M J Lewis; A Manzo; M Bombardieri; C Pitzalis Journal: Arthritis Rheumatol Date: 2020-03-17 Impact factor: 10.995
Authors: Søren Andreas Just; Frances Humby; Hanne Lindegaard; Laurent Meric de Bellefon; Patrick Durez; Elsa Vieira-Sousa; Rui Teixeira; Maria Stoenoiu; Jens Werlinrud; Sofie Rosmark; Pia Veldt Larsen; Arthur Pratt; Ernest Choy; Nagui Gendi; Maya H Buch; Christopher J Edwards; Peter C Taylor; Iain B McInnes; João Eurico Fonseca; Costantino Pitzalis; Andrew Filer Journal: RMD Open Date: 2018-10-26