The Sjögren's Working Group: The 2023 OMERACT meeting and provisional domain generation

Rachael A Gordon¹, Yann Nguyen², Nathan Foulquier³, Maxime Beydon², Tamer A Gheita⁴, Raouf Hajji⁵, Ilfita Sahbudin⁶, Alberta Hoi⁷, Wan-Fai Ng⁸, Jose Alexandre Mendonça⁹, Daniel J Wallace¹⁰, Beverley Shea¹¹, George Aw Bruyn¹², Susan M Goodman¹³, Benjamin A Fisher⁶, Chiara Baldini¹⁴, Karina D Torralba¹⁵, Hendrika Bootsma¹⁶, Esen K Akpek¹⁷, Sezen Karakus¹⁷, Alan N Baer¹⁸, Soumya D Chakravarty¹⁹, Lene Terslev²⁰, Maria-Antonietta D'Agostino²¹, Xavier Mariette², Dana DiRenzo²², Astrid Rasmussen²³, Athena Papas²⁴, Cristina Montoya²⁵, Suzanne Arends¹⁶, Md Yuzaiful Md Yusof²⁶, Ionut Pintilie²⁷, Blake M Warner²⁸, Katherine M Hammitt²⁹, Vibeke Strand³⁰, Coralie Bouillot³¹, Peter Tugwell³², Nevsun Inanc³³, José Luis Andreu³⁴, Marie Wahren-Herlenius³⁵, Valerie Devauchelle-Pensec³, Caroline H Shiboski³⁶, Anas Benyoussef³⁷, Sharmila Masli³⁸, Adrian Y S Lee³⁹, Divi Cornec³, Simon Bowman⁴⁰, Maureen Rischmueller⁴¹, Sara S McCoy⁴², Raphaele Seror²

Affiliations

¹ Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, USA.
² Department of Rheumatology, National Reference Center for Auto-immune Diseases, Sjogren's ERN Reconnect Center, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Université Paris-Saclay, INSERM U1184, Le Kremlin Bicêtre, Paris, France.
³ LBAI, UMR1227, Univ Brest, Inserm, CHU de Brest, Brest, France.
⁴ Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
⁵ Internal Medicine Department, Sidi Bouzid Hospital, University of Sousse, Medicine Faculty of Sousse, 4000, Sousse, Tunisia; International Medical Community (IMC), Via Nomentana, 403, Rome, Lazio 00162, Italy.
⁶ Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK; NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.
⁷ Monash University, Victoria, Australia.
⁸ Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK; NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust & Newcastle University, Newcastle upon Tyne, UK.
⁹ Postgraduate Program in Health Sciences/Rheumatology/Ultrasonography Service, Pontifical Catholic University of Campinas, SP, Brazil.
¹⁰ Cedars-Sinai Medical Center, Los Angeles, California, USA; University of California, David Geffen School of Medicine, Los Angeles, California, USA.
¹¹ Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
¹² Department of Rheumatology, Tergooi MC hospitals, Hilversum, the Netherlands.
¹³ Division of Rheumatology, Hospital for Special Surgery, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
¹⁴ Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
¹⁵ Division of Rheumatology, Department of Medicine, Loma Linda University School of Medicine, Loma Linda, California, USA; Division of Rheumatology, Department of Medicine, University of California Riverside School of Medicine, Riverside, California, USA.
¹⁶ Department Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
¹⁷ Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁸ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁹ Janssen Scientific Affairs, LLC, Horsham, PA, USA, Drexel University College of Medicine, Philadelphia, PA, USA.
²⁰ Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, The University of Copenhagen, Copenhagen, Denmark.
²¹ Rheumatology Department, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, IRCSS, Rome, Italy.
²² Rheumatology Department, University of Pennsylvania, Philadelphia, PA, USA.
²³ Genes and Human Disease Program, Oklahoma Medical Research Foundation. Oklahoma City, OK, USA.
²⁴ Tufts School of Dental Medicine Boston, Massachusetts, USA.
²⁵ Registered Dietitian Active patient volunteer for the Sjogren's Society of Canada, Canada.
²⁶ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK; NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, UK.
²⁷ Rheumatology Department, Connect Medical, Piatra Neamt, Romania.
²⁸ Salivary Disorders Unit, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Maryland, USA.
²⁹ Sjögren's Foundation, Reston, VA, USA.
³⁰ Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
³¹ Sjögren's Europe, Bienne, Switzerland.
³² Dept of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
³³ Division of Rheumatology, Marmara University School of Medicine, Istanbul, Turkey.
³⁴ Rheumatology Department, University Hospital Puerta de Hierro, Majadahonda, Spain.
³⁵ Division of Rheumatology, Department of Medicine, Karolinska Institute, Sweden; Broegelmann Research Laboratory, Department of Clinical Science, University of Bergen, Norway.
³⁶ Department of Orafacial Sciences, University of California San Francisco, San Francisco, CA, USA.
³⁷ Ophthalmology Department, centre hospitalier universitaire de Brest, 2, avenue Foch, 29609 Brest cedex, France.
³⁸ Boston University School of Medicine, Boston, MA, USA.
³⁹ Department of Clinical Immunology & Allergy, Westmead Hospital, Westmead, NSW, Australia.
⁴⁰ Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK; NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK; Institute of Inflammation & Ageing, University of Birmingham, Birmingham, UK, Rheumatology Department, University Hospitals Birmingham, Birmingham, UK and Rheumatology Department, Milton Keynes University Hospital, Milton Keynes, UK.
⁴¹ The Queen Elizabeth Hospital, Woodville and University of Adelaide, Adelaide, Australia.
⁴² Department of Medicine, Division of Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison, USA. Electronic address: ssmccoy@medicine.wisc.edu.

PMID: 38310657
PMCID: PMC10954392
DOI: 10.1016/j.semarthrit.2024.152378

The Sjögren's Working Group: The 2023 OMERACT meeting and provisional domain generation

Rachael A Gordon et al. Semin Arthritis Rheum. 2024 Apr.

. 2024 Apr:65:152378.

doi: 10.1016/j.semarthrit.2024.152378. Epub 2024 Jan 23.

Authors

Affiliations

¹ Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, USA.
² Department of Rheumatology, National Reference Center for Auto-immune Diseases, Sjogren's ERN Reconnect Center, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Université Paris-Saclay, INSERM U1184, Le Kremlin Bicêtre, Paris, France.
³ LBAI, UMR1227, Univ Brest, Inserm, CHU de Brest, Brest, France.
⁴ Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
⁵ Internal Medicine Department, Sidi Bouzid Hospital, University of Sousse, Medicine Faculty of Sousse, 4000, Sousse, Tunisia; International Medical Community (IMC), Via Nomentana, 403, Rome, Lazio 00162, Italy.
⁶ Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK; NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.
⁷ Monash University, Victoria, Australia.
⁸ Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK; NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust & Newcastle University, Newcastle upon Tyne, UK.
⁹ Postgraduate Program in Health Sciences/Rheumatology/Ultrasonography Service, Pontifical Catholic University of Campinas, SP, Brazil.
¹⁰ Cedars-Sinai Medical Center, Los Angeles, California, USA; University of California, David Geffen School of Medicine, Los Angeles, California, USA.
¹¹ Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
¹² Department of Rheumatology, Tergooi MC hospitals, Hilversum, the Netherlands.
¹³ Division of Rheumatology, Hospital for Special Surgery, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
¹⁴ Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
¹⁵ Division of Rheumatology, Department of Medicine, Loma Linda University School of Medicine, Loma Linda, California, USA; Division of Rheumatology, Department of Medicine, University of California Riverside School of Medicine, Riverside, California, USA.
¹⁶ Department Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
¹⁷ Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁸ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁹ Janssen Scientific Affairs, LLC, Horsham, PA, USA, Drexel University College of Medicine, Philadelphia, PA, USA.
²⁰ Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, The University of Copenhagen, Copenhagen, Denmark.
²¹ Rheumatology Department, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, IRCSS, Rome, Italy.
²² Rheumatology Department, University of Pennsylvania, Philadelphia, PA, USA.
²³ Genes and Human Disease Program, Oklahoma Medical Research Foundation. Oklahoma City, OK, USA.
²⁴ Tufts School of Dental Medicine Boston, Massachusetts, USA.
²⁵ Registered Dietitian Active patient volunteer for the Sjogren's Society of Canada, Canada.
²⁶ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK; NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, UK.
²⁷ Rheumatology Department, Connect Medical, Piatra Neamt, Romania.
²⁸ Salivary Disorders Unit, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Maryland, USA.
²⁹ Sjögren's Foundation, Reston, VA, USA.
³⁰ Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
³¹ Sjögren's Europe, Bienne, Switzerland.
³² Dept of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
³³ Division of Rheumatology, Marmara University School of Medicine, Istanbul, Turkey.
³⁴ Rheumatology Department, University Hospital Puerta de Hierro, Majadahonda, Spain.
³⁵ Division of Rheumatology, Department of Medicine, Karolinska Institute, Sweden; Broegelmann Research Laboratory, Department of Clinical Science, University of Bergen, Norway.
³⁶ Department of Orafacial Sciences, University of California San Francisco, San Francisco, CA, USA.
³⁷ Ophthalmology Department, centre hospitalier universitaire de Brest, 2, avenue Foch, 29609 Brest cedex, France.
³⁸ Boston University School of Medicine, Boston, MA, USA.
³⁹ Department of Clinical Immunology & Allergy, Westmead Hospital, Westmead, NSW, Australia.
⁴⁰ Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK; NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK; Institute of Inflammation & Ageing, University of Birmingham, Birmingham, UK, Rheumatology Department, University Hospitals Birmingham, Birmingham, UK and Rheumatology Department, Milton Keynes University Hospital, Milton Keynes, UK.
⁴¹ The Queen Elizabeth Hospital, Woodville and University of Adelaide, Adelaide, Australia.
⁴² Department of Medicine, Division of Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison, USA. Electronic address: ssmccoy@medicine.wisc.edu.

PMID: 38310657
PMCID: PMC10954392
DOI: 10.1016/j.semarthrit.2024.152378

Abstract

Sjögren's disease (SjD) is a systemic autoimmune exocrinopathy with key features of dryness, pain, and fatigue. SjD can affect any organ system with a variety of presentations across individuals. This heterogeneity is one of the major barriers for developing effective disease modifying treatments. Defining core disease domains comprising both specific clinical features and incorporating the patient experience is a critical first step to define this complex disease. The OMERACT SjD Working Group held its first international collaborative hybrid meeting in 2023, applying the OMERACT 2.2 filter toward identification of core domains. We accomplished our first goal, a scoping literature review that was presented at the Special Interest Group held in May 2023. Building on the domains identified in the scoping review, we uniquely deployed multidisciplinary experts as part of our collaborative team to generate a provisional domain list that captures SjD heterogeneity.

Keywords: Artificial intelligence; BIBOT; OMERACT; Review; Scoping literature review; Sjogren's disease.

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Conflict of interest statement

Declaration of competing interest Valerie Devauchelle reports receinving funds for consulting to Novartis, Abbvie, Fresenius Kabi. Divi Cornec declares no personal financial competing interests and received research funding from Novartis and GSK. Benjamin A. Fisher has undertaken consultancy for Novartis, BMS, Servier, Galapagos, Roche, UCB, Sanofi and Janssen, and received grant/research support from Janssen, Celgene, Galapagos, Servier. Alberta Hoi reports receiving research funding from AstraZeneca, Bristol-Myers Squibb, Novartis, Janssen. Chiara Baldini reports receiving funds for consulting to GSK, Novartis and Horizon, honoraria for educational events from GSK and Sanofi, support for attending meetings from Abbvie and Bristol-Myers Squibb. WF Ng has consulted for Novartis, GlaxoSmithKline, Abbvie, BMS, Sanofi, MedImmune, Resolves Therapeutics, Janssen and UCB. Simon Bowman receiving funds for consulting from Bristol-Myers Squibb, Iqvia, Janssen, Kiniksa, Novartis, Otsuka-Visterra. His-salary is part funded by the Birmingham Biomedical Research Centre, Birmingham, UK. Karina Torralba reports receiving funds for consulting to Horizon, AstraZeneca, Janssen; for contracted research work with Bioclinica; for clinical trial funding from Novartis, AstraZeneca, GlaxoSmithKline, Amgen. Athena Papas declares grant funding from Novartis and Horizon; advisory board for Novartis. Ionut Pintilie reports receiving funds for consulting to Abbvie, Novartis, Pfizer, Sandoz, Ewopharma, KRKA, Stada, Boehringer Ingelheim, MagnaPharm, MSD. Xavier Mariette declares consulting fee from Astra Zeneca, BMS, Galapagos, GSK, Novartis, and Pfizer. Maria Antonietta D'Agostino, MD, PhD Speakers, or consultant fees from Amgen, Abbvie, BMS, Novartis, Galapagos, UCB, Pfizer, Lily, Janssen. Alan Baer reports receiving funds for consulting to Bristol-Myers Squibb and iCell Gene Therapeutics. Blake M. Warner declares research funding and material transfer agreements with Pfizer, Inc., and Mitobridge, Inc. Soumya D. Chakravarty is an employee of Janssen Scientific Affairs, LLC, and owns stock or stock options in Johnson & Johnson, of which Janssen Scientific Affairs, LLC is a wholly owned subsidiary. Nevsun Inanc reports claims to have received speakers fee from Novartis, Abbvie, Pfizer, UCB, Eli-Lilly and consultancy fee from Abbvie, UCB, Eli-Lilly. Vibeke Strand reports being a founding member of the executive committee of Outcome Measures in Rheumatology (OMERACT) [1992 – present], an international consensus organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and has received arms-length funding from as many as 36 sponsors. Md Yuzaiful Md Yusof has received speaker fees from Roche and Novartis and consultancy fees from Aurinia Pharmaceuticals and UCB. Suzanne Arends declares consultancy fees from Argenx and Novartis. Anas Alexis Benyoussef is a consultant for Horus Pharma and Quantel Medical. Sharmila Masli is a consultant for Stellular Bio Inc. and Proteris Biotech. Maureen Rischmueller has undertaken consultancy/speaker engagements for AbbVie, Boehringer Ingelheim, Janssen Global Services, Novartis, Pfizer and Sandoz, and received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, GSK, Janssen, Lilly, Novartis, Pfizer, Servier and UCB. Sara McCoy reports receiving funds for consulting to Bristol-Myers Squibb, Horizon, Novartis, Kiniksa, Targe RWE, Otsuka, Visterra, and iCell. Her time is supported by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant 1KL2TR002374 and NIH/NIDCR R03DE031340. Raphaele Seror reports receiving funds for consulting to Bristol-Myers Squibb, Novartis, GSK, Janssen, Amgen. Hendrika Bootsma declares consultancy fees from Argenx, Novartis, BMS, AztraZeneca, Galapagos.Independent grants from AstraZeneca, Novartis, BMS.

Figures

**Figure 1.. SjD Working Group PICOC.**
Our population of interest is primary SjD by 2002 AECG or 2016 ACR/EULAR criteria who participated in a trial with an intervention group (pharmacologic, supportive, or surgical) vs. a placebo or no active treatment arm. Our goal is to generate a core domain set to apply to randomized control trials.

**Figure 2.. SjD Working Group Domain Generation Progress. SjD Working Group Domain Generation Progress.**
We have completed our scoping literature review and domain generation through expert consensus. We are planning our qualitative work. Our next steps include generation of domains and Delphi consensus. Image adapted from the OMERACT Handbook, version 2.1 Updated April 1st 2021; Available from: https://omeracthandbook.org.

See this image and copyright information in PMC

References

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The Sjögren's Working Group: The 2023 OMERACT meeting and provisional domain generation

Affiliations

The Sjögren's Working Group: The 2023 OMERACT meeting and provisional domain generation

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical