Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren's syndrome
Benjamin A Fisher,Roland Jonsson,Roland Jonsson,Troy E. Daniels,Michele Bombardieri,Rachel M. Brown,Peter Morgan,Stefano Bombardieri,Wan-Fai Ng,Athanasios G. Tzioufas,Claudio Vitali,P. J. Shirlaw,Erlin A. Haacke,Sebastian Costa,Hendrika Bootsma,Valérie Devauchelle-Pensec,Timothy R D J Radstake,Xavier Mariette,Andrea Richards,Rebecca J. Stack,Simon J Bowman,Francesca Barone +21 more
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TLDR
Standardised consensus guidance for the use of labial salivary gland histopathology in the classification of PSS and in clinical trials is provided and areas where further research is required to achieve evidence-based consensus are identified.Abstract:
Labial salivary gland (LSG) biopsy is used in the classification of primary Sjogren's syndrome (PSS) and in patient stratification in clinical trials. It may also function as a biomarker. The acquisition of tissue and histological interpretation is variable and needs to be standardised for use in clinical trials. A modified European League Against Rheumatism consensus guideline development strategy was used. The steering committee of the ad hoc working group identified key outstanding points of variability in LSG acquisition and analysis. A 2-day workshop was held to develop consensus where possible and identify points where further discussion/data was needed. These points were reviewed by a subgroup of experts on PSS histopathology and then circulated via an online survey to 50 stakeholder experts consisting of rheumatologists, histopathologists and oral medicine specialists, to assess level of agreement (0-10 scale) and comments. Criteria for agreement were a mean score ≥6/10 and 75% of respondents scoring ≥6/10. Thirty-nine (78%) experts responded and 16 points met criteria for agreement. These points are focused on tissue requirements, identification of the characteristic focal lymphocytic sialadenitis, calculation of the focus score, identification of germinal centres, assessment of the area of leucocyte infiltration, reporting standards and use of prestudy samples for clinical trials. We provide standardised consensus guidance for the use of labial salivary gland histopathology in the classification of PSS and in clinical trials and identify areas where further research is required to achieve evidence-based consensus.read more
Citations
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Journal ArticleDOI
Sjögren syndrome
Pilar Brito-Zerón,W. Baldini,Hendrika Bootsma,Simon J. Bowman,Roland Jonsson,Xavier Mariette,Kathy L. Sivils,Elke Theander,Athanasios G. Tzioufas,Manuel Ramos-Casals +9 more
TL;DR: Knowledge of SjS has progressed substantially, but this disease is still characterized by sicca symptoms, the systemic involvement of disease, lymphocytic infiltration to exocrine glands, the presence of anti-Ro/SSA and anti-La/SSB autoantibodies and the increased risk of lymphoma in patients with SJS.
Journal ArticleDOI
Sjogren's syndrome: An update on disease pathogenesis, clinical manifestations and treatment.
Frederick B. Vivino,Vatinee Y Bunya,Giacomina Massaro-Giordano,Chadwick R. Johr,Stephanie L. Giattino,Annemarie Schorpion,Brian M Shafer,Ammon B. Peck,Kathy L. Sivils,Astrid Rasmussen,John A. Chiorini,Jing He,Julian L. Ambrus +12 more
Journal ArticleDOI
Effect of rituximab on a salivary gland ultrasound score in primary Sjögren’s syndrome: results of the TRACTISS randomised double-blind multicentre substudy
Benjamin A Fisher,Colin C Everett,John Rout,John O’Dwyer,Paul Emery,Paul Emery,Costantino Pitzalis,Wan-Fai Ng,Andrew Carr,Colin T. Pease,Colin T. Pease,Elizabeth Price,Nurhan Sutcliffe,Jimmy Makdissi,Anwar R. Tappuni,Nagui Gendi,Frances Hall,Sharon Ruddock,Catherine Fernandez,Claire Hulme,Kevin A. Davies,Christopher J Edwards,Peter Lanyon,Robert J. Moots,Euthalia Roussou,Andrea Richards,Linda D. Sharples,Michele Bombardieri,Simon J Bowman +28 more
TL;DR: It is demonstrated statistically significant improvement in TUS after rituximab compared with placebo, which encourages further research into both B cell depletion therapies in PSS and SGUS as an imaging biomarker.
Journal ArticleDOI
Current concepts on Sjögren's syndrome – classification criteria and biomarkers
Roland Jonsson,Roland Jonsson,Karl A. Brokstad,Malin V. Jonsson,Nicolas Delaleu,Kathrine Skarstein,Kathrine Skarstein +6 more
TL;DR: Sjogren's syndrome is a lymphoproliferative disease with autoimmune features characterized by mononuclear cell infiltration of exocrine glands, notably the lacrimal and salivary glands as mentioned in this paper.
Journal ArticleDOI
Guidelines for biomarkers in autoimmune rheumatic diseases - evidence based analysis.
Roberto Giacomelli,Antonella Afeltra,Alessia Alunno,E Bartoloni-Bocci,Onorina Berardicurti,Michele Bombardieri,Alessandra Bortoluzzi,Roberto Caporali,Francesco Caso,Ricard Cervera,Maria Sole Chimenti,Paola Cipriani,Emmanuel Coloma,Fabrizio Conti,Salvatore D'Angelo,Salvatore De Vita,Salvatore Di Bartolomeo,Oliver Distler,Andrea Doria,Eugen Feist,Benjamin A Fisher,Maria Gerosa,Michele Gilio,Giuliana Guggino,Vasiliki Liakouli,Domenico Paolo Emanuele Margiotta,Pier Luigi Meroni,Gianluca Moroncini,Federico Perosa,Marcella Prete,Roberta Priori,Chiara Rebuffi,Piero Ruscitti,Raffaele Scarpa,Yehuda Shoenfeld,Monica Todoerti,Francesco Ursini,Guido Valesini,Serena Vettori,Claudio Vitali,Athanasios G. Tzioufas +40 more
TL;DR: The overarching aim of this work was to clarify the meaning of specific biomarkers during autoimmune diseases; their possible role in confirming diagnosis, predicting outcome and suggesting specific treatments.
References
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Journal ArticleDOI
Classification criteria for Sjögren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group
Claudio Vitali,Stefano Bombardieri,Roland Jonsson,Haralampos M. Moutsopoulos,E L Alexander,Steven E. Carsons,Troy E. Daniels,P C Fox,Robert I. Fox,Stuart S. Kassan,S R Pillemer,Norman Talal,M H Weisman +12 more
TL;DR: These classification criteria for Sjögren's syndrome have been re-examined by consensus group members, who have introduced some modifications, more clearly defined the rules for classifying patients with primary or secondary SS, and provided more precise exclusion criteria.
Journal ArticleDOI
The Delphi Technique: Making Sense of Consensus
Chia-Chien Hsu,Brian A. Sandford +1 more
TL;DR: The Delphi technique is well suited as a method for consensus-building by using a series of questionnaires delivered using multiple iterations to collect data from a panel of selected subjects.
Journal ArticleDOI
Preliminary criteria for the classification of Sjögren's syndrome. Results of a prospective concerted action supported by the European Community.
Claudio Vitali,Stefano Bombardieri,Haralampos M. Moutsopoulos,Genesio Balestrieri,Walter Bencivelli,Robert M. Bernstein,Kirsten B. Bjerrum,Susanna Braga,J Coll,Salvatore De Vita,Alexandros A. Drosos,Michael Ehrenfeld,Pierre Y. Hatron,Elaine M Hay,David A. Isenberg,Anne Janin,Joachim R. Kalden,Louis Kater,Yrjö T. Konttinen,Peter J. Maddison,Ravinder N. Maini,Rolf Manthorpe,Olivier Meyer,Pierantonio Ostuni,Y.L. Pennec,Jan Ulrik Prause,Andrea Richards,Bernard Sauvezie,Morten Schiødt,Maria Sciuto,Crispian Scully,Yehuda Shoenfeld,Fotini N. Skopouli,Josef S. Smolen,M L Snaith,Moshe Tishler,Silvano Todesco,Guido Valesini,Patrick J Venables,Marie J. Wattiaux,Pierre Youinou +40 more
TL;DR: Using the findings of this prospective multicenter European study, general agreement can be reached on the diagnostic procedures to be used for patients with SS.
Journal ArticleDOI
Labial salivary gland biopsy in Sjögren's disease
D. M. Chisholm,D. K. Mason +1 more
TL;DR: The labial biopsy is shown to be a further valuable investigative procedure in patients with Sjögren's disease and was used to study 40 patients with connective tissue disease and 60 postmortem subjects.
Journal ArticleDOI
The histopathology of Sjögren's syndrome in labial salivary gland biopsies
John S. Greenspan,John S. Greenspan,Troy E. Daniels,Troy E. Daniels,Norman Talal,Norman Talal,Robert A. Sylvester,Robert A. Sylvester +7 more
TL;DR: Labial salivary gland biopsy specimens from seventy-five patients evaluated for Sjogren's syndrome showed the most marked histologic change, and focus score was found to be the most useful histologic index of severity of the disease.
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