Abstract

Background: Primary Sjogren’s syndrome (pSS) is a systemic chronic autoimmune disease characterized by dryness of the eyes and mouth. Current treatments provide modest benefit, leaving patients with limited therapeutic options. The pathophysiology of pSS involves hyperactivity of autoreactive lymphocytes. Biologic medications target mediators of the immune response. Modulation of autoimmunity in pSS with biologics has gained interest with open-label studies showing promising results. Objectives: This review aims to conduct a systematic literature review of interventional studies investigating the efficacy of biologics in the treatment of pSS. Methods: Literature was searched using the MEDLINE, EMBASE and PubMed databases as well as abstracts in EULAR, ACR and BSR. Results: A total of twelve studies met the inclusion criteria. Infliximab and etanercept showed no significant improvements in fatigue and dryness in pSS compared to placebo. Anakinra showed improvement in fatigue after post-hoc analysis. Small trials in rituximab showed significant improvements in oral and ocular dryness but failed to replicate this in two larger randomised control trials. Belimumab significantly reduced overall disease activity which was driven by improvements in dryness and parotid gland swelling. Open-label studies in epratuzumab and abatacept showed significant reductions in fatigue with abatacept also improving salivary flow and pain in pSS. Conclusion: Intervention with biologics in pSS has shown efficacy in alleviating pSS-associated fatigue and dryness in small RTCs and open-label trials. Larger randomised placebo-controlled trials have been inconsistent in replicating these results. This may be overcome by subgroup analysis, uptake of validated disease activity measuring tools, well-defined selection criteria to increase sample size and further understanding of pathophysiology in pSS. The small number of trials to date means the evidence base for biologics in pSS remains inconclusive.

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