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Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome

OBJECTIVE: To evaluate current evidence on the efficacy and safety of topical and systemic medications in patients with primary Sjögren syndrome (SjS) to inform European League Against Rheumatism treatment recommendations. METHODS: The MEDLINE, EMBASE and Cochrane databases were searched for case-co...

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Autores principales: Brito-Zerón, Pilar, Retamozo, Soledad, Kostov, Belchin, Baldini, Chiara, Bootsma, Hendrika, De Vita, Salvatore, Dörner, Thomas, Gottenberg, Jacques-Eric, Kruize, Aike A., Mandl, Thomas, Ng, Wan-Fai, Seror, Raphaele, Tzioufas, Athanasios G., Vitali, Claudio, Bowman, Simon, Mariette, Xavier, Ramos-Casals, Manuel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6827762/
https://www.ncbi.nlm.nih.gov/pubmed/31749986
http://dx.doi.org/10.1136/rmdopen-2019-001064
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author Brito-Zerón, Pilar
Retamozo, Soledad
Kostov, Belchin
Baldini, Chiara
Bootsma, Hendrika
De Vita, Salvatore
Dörner, Thomas
Gottenberg, Jacques-Eric
Kruize, Aike A.
Mandl, Thomas
Ng, Wan-Fai
Seror, Raphaele
Tzioufas, Athanasios G.
Vitali, Claudio
Bowman, Simon
Mariette, Xavier
Ramos-Casals, Manuel
author_facet Brito-Zerón, Pilar
Retamozo, Soledad
Kostov, Belchin
Baldini, Chiara
Bootsma, Hendrika
De Vita, Salvatore
Dörner, Thomas
Gottenberg, Jacques-Eric
Kruize, Aike A.
Mandl, Thomas
Ng, Wan-Fai
Seror, Raphaele
Tzioufas, Athanasios G.
Vitali, Claudio
Bowman, Simon
Mariette, Xavier
Ramos-Casals, Manuel
author_sort Brito-Zerón, Pilar
collection PubMed
description OBJECTIVE: To evaluate current evidence on the efficacy and safety of topical and systemic medications in patients with primary Sjögren syndrome (SjS) to inform European League Against Rheumatism treatment recommendations. METHODS: The MEDLINE, EMBASE and Cochrane databases were searched for case-control/prospective cohort studies, randomised controlled trials (RCTs) and systematic reviews. RESULTS: 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 mg/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. CONCLUSION: 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.
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spelling pubmed-68277622019-11-20 Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome Brito-Zerón, Pilar Retamozo, Soledad Kostov, Belchin Baldini, Chiara Bootsma, Hendrika De Vita, Salvatore Dörner, Thomas Gottenberg, Jacques-Eric Kruize, Aike A. Mandl, Thomas Ng, Wan-Fai Seror, Raphaele Tzioufas, Athanasios G. Vitali, Claudio Bowman, Simon Mariette, Xavier Ramos-Casals, Manuel RMD Open Sjögren Syndrome OBJECTIVE: To evaluate current evidence on the efficacy and safety of topical and systemic medications in patients with primary Sjögren syndrome (SjS) to inform European League Against Rheumatism treatment recommendations. METHODS: The MEDLINE, EMBASE and Cochrane databases were searched for case-control/prospective cohort studies, randomised controlled trials (RCTs) and systematic reviews. RESULTS: 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 mg/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. CONCLUSION: 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. BMJ Publishing Group 2019-10-28 /pmc/articles/PMC6827762/ /pubmed/31749986 http://dx.doi.org/10.1136/rmdopen-2019-001064 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Sjögren Syndrome
Brito-Zerón, Pilar
Retamozo, Soledad
Kostov, Belchin
Baldini, Chiara
Bootsma, Hendrika
De Vita, Salvatore
Dörner, Thomas
Gottenberg, Jacques-Eric
Kruize, Aike A.
Mandl, Thomas
Ng, Wan-Fai
Seror, Raphaele
Tzioufas, Athanasios G.
Vitali, Claudio
Bowman, Simon
Mariette, Xavier
Ramos-Casals, Manuel
Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome
title Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome
title_full Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome
title_fullStr Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome
title_full_unstemmed Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome
title_short Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren’s syndrome
title_sort efficacy and safety of topical and systemic medications: a systematic literature review informing the eular recommendations for the management of sjögren’s syndrome
topic Sjögren Syndrome
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6827762/
https://www.ncbi.nlm.nih.gov/pubmed/31749986
http://dx.doi.org/10.1136/rmdopen-2019-001064
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