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Meta-Analysis
. 2019 Oct 28;5(2):e001064.
doi: 10.1136/rmdopen-2019-001064. eCollection 2019.

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

Pilar Brito-Zerón  1   2 , Soledad Retamozo  3   4 , Belchin Kostov  5   6 , Chiara Baldini  7 , Hendrika Bootsma  8 , Salvatore De Vita  9 , Thomas Dörner  10 , Jacques-Eric Gottenberg  11 , Aike A Kruize  12 , Thomas Mandl  13 , Wan-Fai Ng  14 , Raphaele Seror  15   16 , Athanasios G Tzioufas  17 , Claudio Vitali  18 , Simon Bowman  19 , Xavier Mariette  15   16 , Manuel Ramos-Casals  2   20
Affiliations
Meta-Analysis

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

Pilar Brito-Zerón et al. RMD Open. .

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 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.

Keywords: Sjøgren's syndrome; multidisciplinary team-care; treatment.

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Conflict of interest statement

Competing interests: SB’s salary is part funded by the Birmingham Biomedical Research Centre.

Figures

Figure 1
Figure 1
Flow chart of the systematic literature review. PICOs, Population, Intervention, Comparison, Outcomes and Study design; RCTs, randomised controlled trials; SjS, Sjögren’s syndrome; SLRs, systematic literature reviews.
See this image and copyright information in PMC

References

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