1377: Humanistic Burden of Sjögren's Disease: A Systematic Review of Treatment Efficacy on Health-Related Quality-of-Life

Background/Purpose: Sjögren’s disease (SjD) is a chronic systemic autoimmune disorder that imposes significant clinical, humanistic, and economic burdens on patients. It is associated with multiple comorbidities and significant heterogeneity in disease manifestation, including an increased risk of lymphoma, which further exacerbate its impact. Despite numerous drugs (such as rituximab and abatacept) having been tested, there are currently no approved treatments for the disease. While some drugs are prescribed to help relieve symptoms, many patients report inadequate relief, which exacerbates the emotional and social impact of the disease. We conducted a systematic literature review (SLR) to identify, summarize, and evaluate the existing evidence on the impact of treatments on the humanistic burden of SjD, with a particular focus on their impact on patients’ health-related quality of life (HRQoL).

Methods: The SLR was conducted using the MEDLINE and Embase databases (via OvidSP), covering the period from January 1, 2014 to April 12, 2024 for publications in the English language. Additional searches were performed in the bibliographies of relevant studies, Google Scholar, disease-specific websites, and conference proceedings. Articles were screened, and data were extracted to report on HRQoL outcomes, including disease-specific instruments (EULAR Sjögren's Syndrome Patient-Reported Index [ESSPRI]), generic tools (European Quality of Life 5 Dimensions [EQ-5D], Short form–36 Health Survey [SF-36], Visual Analogue Scale [VAS]), and specific HRQoL domains such as pain, fatigue, activity participation, anxiety, depression, ocular health, oral health, and sexual health.

Results: Twenty-nine publications reporting the effect of treatment on humanistic burden outcomes of SjD were identified (19 related to systemic treatments and 10 to non-systematic/non-pharmacological interventions; Table 1). In randomized controlled trials (RCTs) involving rituximab, leniolisib, and abatacept, no significant differences in ESSPRI scores were found between treatment and placebo groups, indicating similar levels of symptom burden reduction (Table 2). In contrast, iguratimod and dazodalibep demonstrated significant improvements in overall ESSPRI scores compared to placebo in small or local trials. An RCT of tocilizumab failed to show significant improvements in anxiety or depression outcomes compared to the control group (Table 3). Use of systemic treatments was found to result in non-significant improvements in fatigue, oral dryness, and ocular dryness compared to placebo. Non-pharmacological interventions, including exercise-based therapies and traditional Chinese medicine, also showed inconsistent effects on HRQoL.

Conclusion: Both systemic treatments and non-pharmacological interventions have generally shown limited efficacy in reducing the HRQoL burden in SjD. Although some treatments have demonstrated potential, these findings are primarily derived from clinical studies with small sample sizes and require validation. There remains a significant unmet need for therapies that can effectively alleviate the quality-of-life burden in patients with SjD.