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

INTRODUCTION: Sjögren's disease (SjD) is a chronic autoantibody-driven inflammatory disorder that imposes a significant burden on afflicted patients. SjD is widely underappreciated, underdiagnosed, and undertreated. This may be partly due to the absence of advanced targeted treatments addressing the root cause of the disease. While some drugs are prescribed to help improve symptoms, many patients report inadequate relief, with disease progression and frequent organ damage. This systematic literature review (SLR) assessed the effects of treatments on patients' health-related quality of life (HRQoL). This study was supplemented by a patient focus group to gain additional insight into the humanistic burden of SjD. METHODS: The SLR was conducted using MEDLINE and Embase (OvidSP) results between January 1, 2014, and February 2, 2026, supplemented with bibliographies, Google Scholar, disease-specific websites, and conference proceedings. Articles were screened specifically for HRQoL outcomes, including patient-reported disease-specific instruments (e.g., EULAR Sjögren's Syndrome Patient-Reported Index [ESSPRI]) and other tools focusing separately on fatigue and ocular/oral dryness. A small patient focus group (N = 4) provided further perspectives on disease burden and management. RESULTS: Fifty-three records were identified from 44 unique studies related to systemic treatments, including large case series and randomized controlled trials of traditional immunomodulatory or anti-inflammatory agents and newer biological treatments (e.g., rituximab, abatacept, hydroxychloroquine, leflunomide, corticosteroids, iguratimod, dazodalibep, telitacicept). Most systemic treatments provided no meaningful improvements in fatigue or ocular/oral dryness. SjD focus group participants reported persistent, overlapping symptoms, particularly fatigue and cognitive impairment, that limit daily activities. Participants expressed dissatisfaction with current treatments and a strong desire for holistic therapies that address the root cause, improve symptoms, and prevent disease progression. CONCLUSIONS: Systemic treatments have generally focused on disease activity parameters and have shown limited efficacy in reducing patient-reported symptoms as measured using HRQoL tools in SjD, leaving a significant unmet need for patient-centered holistic therapies.