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EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies
Open accessAbstract
The therapeutic management of Sjögren syndrome (SjS) has not changed substantially in recent decades: treatment decisions remain challenging in clinical practice, without a specific therapeutic target beyond the relief of symptoms as the most important goal. In view of this scenario, the European League Against Rheumatism (EULAR) promoted and supported an international collaborative study (EULAR SS Task Force) aimed at developing the first EULAR evidence and consensus-based recommendations for the management of patients with SjS with topical and systemic medications. The aim was to develop a rational therapeutic approach to SjS patients useful for healthcare professionals, physicians undergoing specialist training, medical students, the pharmaceutical industry and drug regulatory organisations following the 2014 EULAR standardised operating procedures. The Task Force (TF) included specialists in rheumatology, internal medicine, oral health, ophthalmology, gynaecology, dermatology and epidemiology, statisticians, general practitioners, nurses and patient representatives from 30 countries of the 5 continents. Evidence was collected from studies including primary SjS patients fulfilling the 2002/2016 criteria; when no evidence was available, evidence from studies including associated SjS or patients fulfilling previous sets of criteria was considered and extrapolated. The TF endorsed the presentation of general principles for the management of patients with SjS as three overarching, general consensus-based recommendations and 12 specific recommendations that form a logical sequence, starting with the management of the central triplet of symptoms (dryness, fatigue and pain) followed by the management of systemic disease. The recommendations address the use of topical oral (saliva substitutes) and ocular (artificial tear drops, topical non-steroidal anti-inflammatory drugs, topical corticosteroids, topical CyA, serum tear drops) therapies, oral muscarinic agonists (pilocarpine, cevimeline), hydroxychloroquine, oral glucocorticoids, synthetic immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate, leflunomide and mycophenolate), and biological therapies (rituximab, abatacept and belimumab). For each recommendation, levels of evidence (mostly modest) and TF agreement (mostly very high) are provided. The 2019 EULAR recommendations are based on the evidence collected in the last 16 years in the management of primary 2002 SjS patients and on discussions between a large and broadly international TF. The recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations. We hope that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.
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B-cell targeted therapies (with belimumab or rituximab) may be considered in patients with severe, refractory systemic disease (ESSDAI score >14, or high activity in any of the ESSDAI domains).
“Immunosuppressive agents should be mainly used as CSsparing agents, with no evidence supporting the choice of one agent over another and that B-cell targeted therapies (with BLM or RTX) may be considered in patients with severe, refractory systemic disease (ESSDAI score >14, or high activity in any of the ESSDAI domains).”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [142]
Immunosuppressive agents should be mainly used as corticosteroid-sparing agents.
“Immunosuppressive agents should be mainly used as CSsparing agents, with no evidence supporting the choice of one agent over another and that B-cell targeted therapies (with BLM or RTX) may be considered in patients with severe, refractory systemic disease (ESSDAI score >14, or high activity in any of the ESSDAI domains).”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [142]
No evidence supports the choice of one immunosuppressive agent over another.
“Immunosuppressive agents should be mainly used as CSsparing agents, with no evidence supporting the choice of one agent over another and that B-cell targeted therapies (with BLM or RTX) may be considered in patients with severe, refractory systemic disease (ESSDAI score >14, or high activity in any of the ESSDAI domains).”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [142]
The 2019 EULAR recommendations propose that the treatment of systemic disease should be tailored to organ-specific severity using the ESSDAI definitions.
“The new 2019 EULAR recommendations 142 propose that the treatment of systemic disease should be tailored to organ-specific severity using the ESSDAI definitions.”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [142]
The use of antimalarial drug hydroxychloroquine should be restricted to patients with active systemic disease (clinic ESSDAI score ≥1).
“Otherwise, the use of antimalarial drug (HCQ) should be restricted to patients with active systemic disease (clinic ESSDAI score !1).”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [142]
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Metadata
- Authors
- Ramos-Casals, M., Brito-Zerón, P., Bombardieri, S., Bootsma, H., De Vita, S., Dörner, T., Fisher, B. A., Gottenberg, J.-E., Hernandez-Molina, G., Kocher, A., Kostov, B., Kruize, A. A., Mandl, T., Ng, W.-F., Retamozo, S., Seror, R., Shoenfeld, Y., Sisó-Almirall, A., Tzioufas, A. G., Vitali, C., Bowman, S., & Mariette, X.
- Affiliations
- University of Pisa (IT)
- University of Groningen (NL)
- German Rheumatism Research Centre (DE)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Centre National de la Recherche Scientifique (FR)
- University of Basel (CH)
- Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES)
- University Medical Center Utrecht (NL)
- Lund University (SE)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Consejo Nacional de Investigaciones Científicas y Técnicas (AR)
- St Petersburg University (RU)
- National and Kapodistrian University of Athens (GR)
- ORCID
- Ramos-Casals, Manuel
- Bombardieri, Stefano
- Bootsma, Hendrika
- Dörner, Thomas
- Fisher, Benjamin A
- Gottenberg, Jacques-Eric
- Hernandez-Molina, Gabriela
- Kocher, Agnes
- Kostov, Belchin
- Kruize, Aike A.
- Mandl, Thomas
- Ng, Wan-Fai
- Retamozo, Soledad
- Shoenfeld, Yehuda
- Sisó-Almirall, Antoni
- Tzioufas, Athanasios G.
- Vitali, Claudio
- Bowman, Simon
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2020-01
- Volume
- 79
- Issue
- 1
- Pages
- 3-18
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2982538063
- Cited by
- 732
- References
- 111
- Citations by year
- 2026: 134 · 2025: 145 · 2024: 142 · 2023: 84 · 2022: 88 · 2021: 82 · 2020: 54
- FWCI
- 38.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of the Rheumatic Diseases (publishedVersion)
- PubMed (publishedVersion)
- UPCommons institutional repository (Universitat Politècnica de Catalunya) (acceptedVersion, other-oa)
- Rovira & Virgili repository (submittedVersion, cc-by)
- HAL (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, public-domain)
- edoc (University of Basel) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- European League Against Rheumatism (CLI0174)
- Topics
- Health Sciences › Medicine › Physiology (medical) › Salivary Gland Disorders and Functions
- Health Sciences › Medicine › Ophthalmology › Ocular Surface and Contact Lens
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Keywords
- Sjögren's syndrome, treatment guidelines, dry eye, xerostomia, fatigue, topical treatment, systemic therapy, artificial saliva, artificial tears, topical corticosteroids, cyclosporine, pilocarpine, cevimeline, hydroxychloroquine, glucocorticoids, immunosuppressants, biologic therapy, rituximab, abatacept
- MeSH terms
- Adrenal Cortex Hormones, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids, Humans, Hydroxychloroquine, Immunosuppressive Agents, Saliva, Artificial, Sjogren's Syndrome, Cyclosporine, Antirheumatic Agents, Muscarinic Agonists, Administration, Ophthalmic, Lubricant Eye Drops
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