{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T10:52:01Z","timestamp":1790506321121,"version":"4.1.0"},"reference-count":67,"publisher":"BMJ","issue":"2","funder":[{"DOI":"10.13039\/501100008741","name":"EULAR","doi-asserted-by":"crossref","award":["EULAR PROJECT CLI074"],"award-info":[{"award-number":["EULAR PROJECT CLI074"]}],"id":[{"id":"10.13039\/501100008741","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2019,9,29]]},"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate current evidence on the efficacy and safety of topical and systemic medications in patients with primary Sj\u00f6gren syndrome (SjS) to inform European League Against Rheumatism treatment recommendations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The MEDLINE, EMBASE and Cochrane databases were searched for case-control\/prospective cohort studies, randomised controlled trials (RCTs) and systematic reviews.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Current evidence in primary SjS patients fulfilling the 2002 criteria is based on the data from 9 RCTs, 18 prospective cohort studies and 5 case-control studies. Two Cochrane systematic literature reviews (SLRs) have reported that topical treatments for dry mouth and dry eye are safe and effective. Ocular cyclosporine A was safe and effective in two RCTs including 1039 patients with dry eye syndrome. Two Cochrane SLRs on serum tear drops and plugs showed inconsistency in possible benefits, both for symptoms and objective measures. Five RCTs reported significant improvements in oral dryness and salivary flow rates for pilocarpine and cevimeline. An RCT showed no significant placebo-differences for hydroxychloroquine 400\u2009mg\/day for the primary outcome (visual analogue scale (VAS) composite of dryness, fatigue and pain). We identified seven RCTs carried out in primary SjS patients. RCTs using infliximab, anakinra and baminercept found no placebo-differences for the primary outcomes. The two largest RCTs randomised 255 patients to receive rituximab or placebo and reported no significant results in the primary outcome (VAS composite), while prospective studies suggested efficacy in systemic disease.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The current evidence supporting the use of the main topical therapeutic options of primary SjS is solid, while limited data from RCTs are available to guide systemic therapies.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2019-001064","type":"journal-article","created":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T07:02:30Z","timestamp":1572332550000},"page":"e001064","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":78,"title":["Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sj\u00f6gren\u2019s syndrome"],"prefix":"10.1136","volume":"5","author":[{"given":"Pilar","family":"Brito-Zer\u00f3n","sequence":"first","affiliation":[{"name":"Autoimmune Diseases Unit, Department of Medicine, Hospital CIMA-Sanitas, Barcelona, Spain"},{"name":"Laboratory of Autoimmune Diseases Josep Font, CELLEX, IDIBAPS, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0075-4454","authenticated-orcid":false,"given":"Soledad","family":"Retamozo","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Instituto Modelo de Cariolog\u00eda Privado S.R.L, Instituto Universitario de Ciencias Biom\u00e9dicas de C\u00f3rdoba, Cordoba, Argentina"},{"name":"Instituto De Investigaciones En Ciencias De La Salud (INICSA), Universidad Nacional de C\u00f3rdoba (UNC), Cordoba, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2126-3892","authenticated-orcid":false,"given":"Belchin","family":"Kostov","sequence":"additional","affiliation":[{"name":"Research Primary Healthcare Transversal Research Group, CAP Les Corts, CAPSBE, IDIBAPS, Barcelona, Spain"},{"name":"Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Baldini","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Universita degli Studi di Pisa, Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrika","family":"Bootsma","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The 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A.","family":"Kruize","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Mandl","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Skane University Hospital Malm\u00f6, Lund University, Lund, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan-Fai","family":"Ng","sequence":"additional","affiliation":[{"name":"NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raphaele","family":"Seror","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Assistance Publique \u2013 H\u00f4pitaux de Paris, H\u00f4pitaux Universitaires Paris-Sud, Le Kremlin-Bic\u00eatre, Le Kremlin-Bicetre, France"},{"name":"Center for Immunology of Viral Infections and Autoimmune Diseases, INSERM UMR 1184, Universit\u00e9 Paris-Sud, Universit\u00e9 Paris-Saclay, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athanasios G.","family":"Tzioufas","sequence":"additional","affiliation":[{"name":"Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Vitali","sequence":"additional","affiliation":[{"name":"Villa San Giuseppe, Istituto S. 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