NEw Clinical Endpoints in primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients

Resultado final

EAB cooperation report that will summarize the Experts profiles and their roles.

An Ethical Advisory board (EAB) will be defined and formalized in a EAB collaboration report. It will include the list of members, their role and frequency of the meetings.

A shortlist of candidate serum/saliva based biomarkers to monitor disease progression and damage in the salivary glands

We will generate a list of biomarkers in the serum and blood that better reflect in the extent of histological damage in the samples analysed. and the diverse morphometric items identified.

A shortlist of candidate blood biomarkers for stratifying pSS patients to be further evaluated in Task 4.6.

Using the pSS subsets identified in D4.2 to identify blood-based biomarkers characterising these subsets. Blood-based biomarkers may be derived from, but not limited to serum/plasma, whole blood or peripheral mononuclear cells, and the biomarkers may be proteins, metabolities and/or RNA. Priority will be given to biomarkers that are relatively easy to measure accurately and reproducibly using widely available molecular technology.

Initial Exploitation plan

A preliminary exploitation plan will be createdwhen the project begins and updated yearly. The plan will summarize the strategy and the concrete actions put in place by the NECESSITY Consortium for the optimal protection and exploitation of the results generated by the project

A comprehensive dataset on a tranSMART platform with clinical and biological data from well-characterised pSS cohorts and clinical trials.

We will integrate the available datasets from the pSS cohorts and clinical trials available for the NECESSITY project onto a tranSMART platform. It will involve creation and harmonization all the descriptive terms for the clinical and biological data of these datasets

Set of inclusion criteria for the WP6 clinical trial by identifying patients' subsets being the most responsive to treatment based on ESSDAI, ESSPRI and other major outcomes.

Identification of patients’ subsets being the most responsive to treatment based on major clinical outcomes, by analysis of data form all previous clinical trial data available at the time of analysis

Communication Policy

A communication Policy will be put in place to ensure that: i) all innovation related activities are captured, assessed, and the IP protected and ii) all NECESSITY Partners will comply with the rules of IMI2 JU Grant Agreement and the IMI2 JU Communication Guide regarding the dissemination activities and the protection of foreground generated within the project

EAB second report on ethical issues

The EAB will be held at month 26 of the project and minutes prepared.

A list of clinical phenotypic subsets of pSS with differential clinical and/or biological responses to therapies.

We will identify clinically and biological meaningful subsets of pSS patients through interrogating the combined dataset of D4.1 using mathematical and statistical modelling

A Shortlist of blood-based biomarkers derived from novel technologies.

Similar to D4.3, but this deliverable focus on biomarkers identified using novel technologies which are more exploratory in nature but may enable deeper understandings of the pathobiology of the pSS subsets.

A shortlist of histological parameters to monitor inflammatory and athropic changes in the salivary glands

We will provide a list of validated parameters, such as percentage of infiltrated area, average infiltrating size. Those will be tested across independent laboratories and used on available samples to generate correlations with measured areas of atrophy.

Final version of the protocol of the NECESSITY trial

The summary of the definitive protocol will be available on nih.gov.

EAB first report on ethical issues

The EAB will be held at month 12 of the project and minutes prepared.

EAB third report on ethical issues

The EAB will be held at month 48 of the project and minutes prepared

Initial Dissemination and Communication plan.

A preliminary dissemination and communication plan will be createdwhen the project begins and updated yearly. The plan will summarize the strategy and the concrete actions put inplace by the NECESSITY Consortium for the optimal dissemination and communication of the resultsgenerated by the project

A shortlist of candidate blood biomarkers identified within PRECISESADS to be further evaluated in Task 4.6. and 4.7.

Similar to D4.3 but data will be based on dataset from the PRECISESADS cohort.

Mid-term Exploitation plan

A mid-term exploitation plan will be created at M36. The plan will revise and improve the strategy and the concrete actions put in place by the NECESSITY Consortium for the optimal protection and exploitation of the results generated by the project.

Mid-term Communication and Dissemination plan

A mid-term dissemination and communication plan will be createdat M36. The plan will revise and improve the strategy and the concrete actions put inplace by the NECESSITY Consortium for the optimal dissemination and communication of the results generated by the project.

First version of the protocol of the NECESSITY trial finalized

A first version of the complete NECESSITY trial protocol meeting requirements for submission to health authorities

A shortlist of histological parameters to monitor disease progression and lymphoma development in the salivary glands

We will validate a series of parameters, able to predict in repeated longitudinal biopsies from the same patients the development of lymphoma. Items considered will include morphometric measurements of lymphoepithelial areas and histological features of the germinal centres.

Identification of a consensual salivary gland US scoring system to be used in the WP6 clinical trial.

Definition of a consensual Scoring of salivary gland US

Third workshop sharing opinions of patients, experts and health authorities

Analytics on data; identify specific data needs & statistically assess to incorporate into workshop.Same as above but with updated inputs from WP1-WP7. Provide data readout and results to HA, patient groups & payers for feedback on acceptance of endpoints, clinically meaningful change measurements, PROs, etc. in Sjogren’s.

Second workshop sharing opinions of patients, experts and health authorities

Same as above but with updated inputs from WP1-WP7 on the clinical development plan. Finalize study protocol based on HA, patient group & payer feedback.

First workshop on clinical protocol development sharing opinions of patients, experts and health authorities

Advance identification of and signed contracts for external participants; Admin logistics (location, contracts, timing). Creation of materials from draft clinical outputs (from WP1-WP7). Plan information to be included in briefing package to be shared with HAs, patient groups & payers. Plan timing for HA/payer/patient group consultation and feedback.

NECESSITY website

The NECESSITY website will be accessible on the internet at month 6 and it will be revised and improvedduring the whole course of the action. Part of the website will be password-protected and dedicated to internal communication.

Publicaciones

Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome

Autores: Raphaele Seror, Gabriel Baron, Marine Camus, Divi Cornec, Elodie Perrodeau, Simon J Bowman, Michele Bombardieri, Hendrika Bootsma, Jacques-Eric Gottenberg, Benjamin Fisher, Wolfgang Hueber, Joel A van Roon, Valérie Devauchelle-Pensec, Peter Gergely, Xavier Mariette, Raphael Porcher, NECESSITY WP5 - STAR development working group;
Publicado en: Ann Rheum Dis ., 2022, Página(s) ahead of print, ISSN 0003-4967
Editor: BMJ Publishing Group

Development of a web-based ecological momentary assessment tool to measure day-to-day variability of the symptoms in patients with Sjögren’s disease

Autores: Laurie Georgel, Anas-Alexis Benyoussef, Sofian Berrouiguet, Dewi Guellec, Guillermo Carvajal Alegria, Thierry Marhadour, Sandrine Jousse-Joulin, Béatrice Cochener-Lamard, Marc Labetoulle, Jacques-Eric Gottenberg, Tristan Bourcier, Gaétane Nocturne, Alain Saraux, Xavier Mariette, Maëlys Consigny, Michel Gravey, Valérie Devauchelle-Pensec, Raphaele Seror, Divi Cornec
Publicado en: RMD Open, Edición 10, 2024, Página(s) e004526, ISSN 2056-5933
Editor: BMJ Publishing Group Ltd
DOI: 10.1136/rmdopen-2024-004526

Variability in primary Sjögren’s syndrome is driven by interferon alpha, and genetically associated with the class II HLA DQ locus

Autores: Diana Trutschel, Pierre Bost, Xavier Mariette, Vincent Bondet, Alba Llibre, et al, Milieu Interieur, ASSESS investigators, and NECESSITY consortium
Publicado en: Arthritis Rheumatol., 2022, ISSN 2326-5205
Editor: American College of Rheumatology
DOI: 10.1002/art.42265

Leflunomide/hydroxychloroquine combination therapy targets type I IFN-associated proteins in patients with Sjögren’s syndrome that show potential to predict and monitor clinical response

Autores: Safae Hamkour, Eefje HM van der Heijden, Ana P Lopes, Sofie L M Blokland, Cornelis P J Bekker, Cornelia G Van Helden-Meeuwsen, Marjan A Versnel, Aike A Kruize, Timothy RDJ Radstake, Helen L Leavis, Maarten R Hillen, Joel AG van Roon
Publicado en: RMD Open, Edición 9, 2023, Página(s) e002979, ISSN 2056-5933
Editor: BMJ Publishing Group
DOI: 10.1136/rmdopen-2023-002979

Efficacy of BAFF inhibition and B-cell depletion in non-obese diabetic mice as a spontaneous model for Sjögren’s disease

Autores: Renaud Felten, Anne-Perrine Foray, Pascal Schneider, Cindy Marquet, Coralie Pecquet, Fanny Monneaux, Hélène Dumortier, Jean Sibilia, Fabrice Valette, Lucienne Chatenoud, Jacques-Eric Gottenberg
Publicado en: RMD Open, Edición 10, 2024, Página(s) e004112, ISSN 2056-5933
Editor: BMJ Publishing Group Ltd.
DOI: 10.1136/rmdopen-2024-004112

Association Between Bruton's Tyrosine Kinase Gene Overexpression and Risk of Lymphoma in Primary Sjögren's Syndrome

Autores: Pierre-Marie Duret, Cedric Schleiss,Lou Kawka,Nicolas Meyer, Tao YeAlain Saraux, Valérie Devauchelle-Pensec, Raphaele Seror,Claire Larroche, Aleth Perdriger,Jean Sibilia, Laurent Vallat, Luc-Matthieu Fornecker, Gaetane Nocturne,Xavier Mariette, and Jacques-Eric Gottenberg
Publicado en: Arthritis & Rheumatology, 2023, ISSN 2326-5205
Editor: Wiley Periodicals LLC
DOI: 10.1002/art.42550

Automation of dry eye disease quantitative assessment: A review.

Autores: Brahim, I, Lamard, M, Benyoussef, A-A, Quellec, G.
Publicado en: Clin Experiment Ophthalmol., 2022, ISSN 1442-9071
Editor: Wiley Press
DOI: 10.1111/ceo.14119

Salivary gland epithelial cells from patients with Sjögren’s syndrome induce B-lymphocyte survival and activation

Autores: Elodie Rivière, Juliette Pascaud, Nicolas Tchitchek, Saida Boudaoud, Audrey Paoletti, Bineta Ly, Anastasia Dupré, Hua Chen, Alice Thai, Norm Allaire, Bernd Jagla, Michael Mingueneau, Gaetane Nocturne, Xavier Mariette
Publicado en: Annals of the Rheumatic Diseases, Edición 79/11, 2020, Página(s) 1468-1477, ISSN 0003-4967
Editor: BMJ Publishing Group
DOI: 10.1136/annrheumdis-2019-216588

Identification of distinct subgroups of Sjögren's disease by cluster analysis based on clinical and biological manifestations: data from the cross-sectional Paris-Saclay and the prospective ASSESS cohorts

Autores: Yann Nguyen, Gaëtane Nocturne, Julien Henry, Wan-Fai Ng, Rakiba Belkhir, Frédéric Desmoulins, Elisabeth Bergé, Jacques Morel, Aleth Perdriger, Emmanuelle Dernis, Valérie Devauchelle-Pensec, Damien Sène, Philippe Dieudé, Marion Couderc, Anne-Laure Fauchais, Claire Larroche, Olivier Vittecoq, Carine Salliot, Eric Hachulla, Véronique Le Guern, Jacques-Eric Gottenberg, Xavier Mariette, Raphaè
Publicado en: The Lancet Rheumatology, Edición 6, 2024, Página(s) e216-e225, ISSN 2665-9913
Editor: Elsevier
DOI: 10.1016/s2665-9913(23)00340-5

Alteration of innate lymphoid cell homeostasis mainly concerns salivary glands in primary Sjögren’s syndrome

Autores: Lou Kawka, Renaud Felten, Cédric Schleiss, Jean-Daniel Fauny, Pauline Le Van Quyen, Hélène Dumortier, Fanny Monneaux, Jacques-Eric Gottenberg
Publicado en: RMD Open, Edición 9, 2023, Página(s) e003051, ISSN 2056-5933
Editor: RMD open
DOI: 10.1136/rmdopen-2023-003051

Distinct Pathophysiologic Pathways Support Stratification of Sjögren's Disease Based on Symptoms, Clinical, and Routine Biological Data

Autores: Yann Nguyen, Maxime Beydon, Jacques‐Eric Gottenberg, Jacques Morel, Aleth Perdriger, Emmanuelle Dernis, Divi Cornec, Valérie Devauchelle‐Pensec, Damien Sène, Philippe Dieudé, Marion Couderc, Anne‐Laure Fauchais, Claire Larroche, Olivier Vittecoq, Carine Salliot, Eric Hachulla, Véronique Le Guern, Xavier Mariette, Raphaèle Seror, Gaëtane Nocturne
Publicado en: Arthritis & Rheumatology, 2025, ISSN 2326-5191
Editor: Hoboken
DOI: 10.1002/art.43096

Interleukin‐7/Interferon Axis Drives T Cell and Salivary Gland Epithelial Cell Interactions in Sjögren’s Syndrome

Autores: Elodie Rivière, Juliette Pascaud, Alexandre Virone, Anastasia Dupré, Bineta Ly, Audrey Paoletti, Raphaèle Seror, Nicolas Tchitchek, Michael Mingueneau, Nikaïa Smith, Darragh Duffy, Lydie Cassard, Nathalie Chaput, Sabrina Pengam, Vanessa Gauttier, Nicolas Poirier, Xavier Mariette, Gaetane Nocturne
Publicado en: Arthritis & Rheumatology, Edición 73, 2023, Página(s) 631-640, ISSN 2326-5191
Editor: Arthritis and Rheumatology
DOI: 10.1002/art.41558

Comorbidities in the UK Primary Sjögren's Syndrome Registry

Autores: Jessica Tarn, Dennis Lendrem, Michael Barnes, John Casement1 and Wan-Fai Ng
Publicado en: Front Immunol, Edición 16643224, 2022, ISSN 1664-3224
Editor: Frontiers Media S.A.
DOI: 10.3389/fimmu.2022.864448

TRACTISS Study research group (2023). Serum and tissue biomarkers associated with CRESS and STAR response to B-cell targeted therapy in TRACTISS trial of Sjogren's syndrome.

Autores: Elena Pontarini,Elisabetta Sciacca,Farzana Chowdhury,Sofia Grigoriadou,Felice Rivellese, William J. Murray-Brown, Davide Lucchesi,Liliante Fossati-Jimack,Alessandra Nerviani, Edyta Jaworska,Giulia Maria Ghirardi,Chiara Giacomassi,Paul Emery,Wan Fai Ng Nurhan Sutcliffe,Colin Everett, Catherine Fernandez, Anwar Tappuni,Raphael Seror,Xavier Mariette,Raphael Porcher,Giulia Cavallaro,Alfredo Pulvirenti
Publicado en: Arthritis & Rheumatology, 2023, ISSN 2326-5205
Editor: Wiley Periodicals LLC
DOI: 10.1002/art.42772

Revisiting the JOQUER trial: stratification of primary Sjögren’s syndrome and the clinical and interferon responseto hydroxychloroquine

Autores: Alexis Collins, Dennis Lendrem, James Wason, Jessica Tarn, Nadia Howard‑Tripp, Iris Bodewes, Marjan A. Versnel, Jacques‑Eric Gottenberg, Raphaele Seror, Xavier Mariette, Wan‑Fai.
Publicado en: Rheumatology International, 2021, ISSN 1559-0836
Editor: John Wiley and Sons Ltd
DOI: 10.1007/s00296-021-04927-y

Consensus gene modules strategy identifies candidate blood-based biomarkers for primary Sjögren's disease

Autores: Cheïma Boudjeniba, Perrine Soret, Diana Trutschel, Antoine Hamon, Valentin Baloche, Bastien Chassagnol, Emiko Desvaux, Antoine Bichat, Audrey Aussy, Philippe Moingeon, Céline Lefebvre, Sandra Hubert, Marta Alarcon-Riquelmé, Wan-Fai Ng, Jacques-Eric Gottenberg, Benno Schwikowski, Michele Bombardieri, Joel A.G. van Roon, Xavier Mariette, Mickaël Guedj, Etienne Birmele, Laurence Laigle, Etienne B
Publicado en: Clinical Immunology, Edición 264, 2025, Página(s) 110241, ISSN 1521-6616
Editor: Academic Press
DOI: 10.1016/j.clim.2024.110241

Examining the biological pathways underlying clinical heterogeneity in Sjogren's syndrome: proteomic and network analysis

Autores: Joe Scott Berry, Jessica Tarn, John Casement, Pierre-Marie Duret, Lauren Scott, Karl Wood, Svein-Joar Johnsen, Gunnel Nordmark, Valérie Devauchelle-Pensec, Raphaele Seror, Benjamin Fisher, Fransesca Barone, Simon J Bowman, Michele Bombardieri, Dennis Lendrem, Renaud Felten, Jacques-Eric Gottenberg, Wan-Fai Ng
Publicado en: Annals of the Rheumatic Diseases, Edición 83, 2025, Página(s) 88-95, ISSN 0003-4967
Editor: BMJ Publishing Group
DOI: 10.1136/ard-2023-224503

Selection of study endpoints and patients for clinical trials in primary Sjögren's syndrome

Autores: Suzanne Arends, Liseth de Wolff, Liselotte Deroo, Gwenny M Verstappen, Arjan Vissink, Frans G M Kroese, Dirk Elewaut, Isabelle Peene, Hendrika Bootsma
Publicado en: Clinical and Experimental Rheumatology, 2022, ISSN 0392-856X
Editor: Pacini Editore SpA
DOI: 10.55563/clinexprheumatol/yagocb

Current and future therapies for primary Sjögren syndrome

Autores: Seror R, Nocturne G, Mariette X.
Publicado en: Nat. Rev Rheumatol., 2021, ISSN 1759-4804
Editor: Springer Nature
DOI: 10.1038/s41584-021-00634-x

Juvenile Sjögren's Syndrome: Clinical Characteristics With Focus on Salivary Gland Ultrasonography

Autores: Daniel S. Hammenfors, Valéria Valim, Blanca E. R. G. Bica, Sandra G. Pasoto, Vibke Lilleby, Juan Carlos Nieto‐González, Clovis A. Silva, Esther Mossel, Rosa M. R. Pereira, Aline Coelho, Hendrika Bootsma, Akaluck Thatayatikom, Johan G. Brun, Malin V. Jonsson
Publicado en: Arthritis Care & Research, Edición 72/1, 2019, Página(s) 78-87, ISSN 2151-464X
Editor: John Wiley & Sons Inc.
DOI: 10.1002/acr.23839

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