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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

Brito-Zerón, Pilar ; Retamozo, Soledad ; Kostov, Belchin ; Baldini, Chiara ; Bootsma, Hendrika ; De Vita, Salvatore ; Dörner, Thomas ; Gottenberg, Jacques Eric ; Kruize, Aike A. and Mandl, Thomas LU , et al. (2019) In RMD Open 5(2).
Abstract

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... (More)

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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publication status
published
subject
keywords
multidisciplinary team-care, Sjøgren's syndrome, treatment
in
RMD Open
volume
5
issue
2
article number
e001064
publisher
BMJ Publishing Group
external identifiers
  • scopus:85074397775
  • pmid:31749986
ISSN
2056-5933
DOI
10.1136/rmdopen-2019-001064
language
English
LU publication?
yes
id
e1eb3285-e5c4-47d1-96b4-79b6b1ce83a3
date added to LUP
2019-11-09 14:33:40
date last changed
2020-02-19 05:41:42
@article{e1eb3285-e5c4-47d1-96b4-79b6b1ce83a3,
  abstract     = {<p>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.</p>},
  author       = {Brito-Zerón, Pilar and Retamozo, Soledad and Kostov, Belchin and Baldini, Chiara and Bootsma, Hendrika and De Vita, Salvatore and Dörner, Thomas and Gottenberg, Jacques Eric and Kruize, Aike A. and Mandl, Thomas and Ng, Wan Fai and Seror, Raphaele and Tzioufas, Athanasios G. and Vitali, Claudio and Bowman, Simon and Mariette, Xavier and Ramos-Casals, Manuel},
  issn         = {2056-5933},
  language     = {eng},
  month        = {10},
  number       = {2},
  publisher    = {BMJ Publishing Group},
  series       = {RMD Open},
  title        = {Efficacy and safety of topical and systemic medications : A systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome},
  url          = {http://dx.doi.org/10.1136/rmdopen-2019-001064},
  doi          = {10.1136/rmdopen-2019-001064},
  volume       = {5},
  year         = {2019},
}