Background/Purpose: Primary Sjögren’s syndrome (pSS) is a chronic autoimmune disease characterised by lymphocytic infiltration of exocrine glands, leading to sicca symptoms that severely impact quality of life. While systemic immunomodulatory therapies continue to evolve, local treatments remain the mainstay for symptom relief. This systematic literature review evaluated the efficacy and safety of currently available and emerging local interventions for dryness in ocular, oral, and other mucosal domains in pSS.

Methods: A systematic search was conducted across PubMed, Ovid Medline, and the Cochrane Library from 2010 to 2024. Eligible studies included randomised clinical trials, systematic reviews, and meta-analyses assessing local therapies for dryness symptoms in adult patients diagnosed with pSS according to 2016 ACR/EULAR criteria. Studies were screened based on pre-defined inclusion criteria, with a minimum sample size of 10 participants. Outcomes included both subjective symptom scores and objective measures of glandular function.

Results: Assessing a total of 44 trials of xeropthalmia it was evident that sodium hyaluronate with trehalose, lipid-based drops showed superior efficacy over standard artificial tears. Topical cyclosporine A, tacrolimus, and low-potency corticosteroids were effective in moderate to severe cases, while biologic tear substitutes (e.g., autologous for ocular dryness serum, PRP) demonstrated potential in refractory disease. Novel agents such as lifitegrast, diquafosol, and lacritin reported favourable results with minimal adverse effects. In the management of xerostomia, pilocarpine and cevimeline improved salivary output (pilocarpine concentrations significantly increased whole salivary flow compared to placebo (p < 0.01)) and symptom perception (but were limited by systemic adverse effects. Non-pharmacologic approaches—including xylitol-based lozenges, malic acid tablets, mentholated gum, and intraoral electrostimulation devices—proved beneficial in selected patients with residual gland function. Saliva substitutes, while safe, provided only short-lived relief and were often limited by palatability or low adherence. For dryness in other mucosal domains (nasal, vaginal, pharyngeal), evidence remains sparse and largely empirical.

Conclusion: Local therapies remain a cornerstone in the management of sicca symptoms in pSS, particularly given the limited access to systemic immunomodulatory drugs. While several interventions demonstrated promising efficacy and safety profiles, most evidence was derived from small, heterogeneous studies. Further research is needed to establish standardised outcome measures, clarify long-term benefits, and guide personalised therapeutic strategies.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/updates-in-the-local-treatments-in-primary-sjogrens-syndrome-efficacy-and-safety/