EXTON, PA, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Sjögren’s Disease (SjD) continues to present significant diagnostic and therapeutic challenges within rheumatology, according to Spherix Global Insights’ Market Dynamix™: Sjögren’s Disease (US) 2025 report. Despite growing awareness and expanding research activity, the majority of rheumatologists describe SjD as one of the most difficult conditions they manage, largely due to a lack of disease-modifying therapies and inconsistent or lacking clinical guidance.
Among diagnosed cases, approximately half are classified as primary SjD, which occurs independently, and half as secondary (associated) SjD, which develops alongside other autoimmune diseases such as rheumatoid arthritis or lupus. The distinction between primary and secondary SjD also contributes to ongoing diagnostic challenges, as overlapping symptoms and comorbid autoimmune conditions can obscure recognition of the disease. As a result, rheumatologists estimate that as many as one-third of individuals with SjD may remain undiagnosed.
Symptomatically, patients often experience ocular and oral dryness, fatigue, and pain for extended periods of time before being referred to a specialist. Primary care physicians, ophthalmologists, and dentists are the main sources of referrals, yet only a minority of cases are confirmed prior to rheumatology evaluation. As one specialist explained, “[PCPs] need more guidance on what to look for and when referral is appropriate.” Another added, “Primary care often just checks antibodies without really understanding the clinical context. Better education on diagnostic criteria and how to interpret serologies would go a long way.”
Although the American College of Rheumatology (ACR) and EULAR remain the top sources for SjD guidance, specialists widely agree that current recommendations lack the clarity needed for complex or refractory presentations. “There’s no clear treatment algorithm,” one rheumatologist commented. “It’s based on what the Sjögren’s is doing. There isn’t a standard path like we have with RA.” This uncertainty contributes to inconsistent treatment approaches and further underscores the need for educational leadership within the field.
Manufacturers are well positioned to help close these gaps. Given the complex path to diagnosis, efforts to educate primary care and other healthcare providers on referral triggers, expand awareness of updated terminology, and enhance patient understanding of the disease could meaningfully impact time to recognition and care. Rheumatologists also highlight the opportunity for manufacturer-driven education that complements, rather than duplicates, society guidelines by translating evolving evidence into practical application. “I think there’s an educational gap in how to explain this disease to patients, especially the fact that symptoms wax and wane and don’t always correlate with lab markers,” one physician shared.
The need for greater manufacturer involvement is reflected in strong consensus across the community, with most rheumatologists agreeing that industry support in education, therapy development, and access will be essential to advancing the field. “It’s not a disease rheumatologists manage alone,” one respondent summarized. “Management is really a team effort.”
Amid this uncertainty, the SjD pipeline is gaining momentum—now led by Novartis’ ianalumab, which became the first therapy to demonstrate positive Phase 3 results in Sjögren’s disease following its August 2025 announcement. Other promising agents cited by rheumatologists include Bristol Myers Squibb’s TYK2 inhibitor Sotyktu (deucravacitinib), Johnson & Johnson’s nipocalimab, Amgen’s dazodalibep, and Argenx’s Vyvgart Hytrulo (efgartigimod), each targeting distinct immunologic pathways. Together, these developments signal a potential inflection point for SjD treatment, shifting future management toward targeted, disease-modifying approaches after years of primarily symptomatic care.
As multiple late-stage mechanisms progress toward potential approval, the manufacturers that invest early in education—both to shorten the diagnostic pathway and to contextualize new treatment options—will be best positioned to influence the next evolution of Sjögren’s Disease management.
Market Dynamix™ is an independent, data-driven service focused on understanding the evolving dynamics of specialty markets poised for disruption. Leveraging quantitative and qualitative research, the service evaluates current treatment approaches, unmet needs, and likely impact of pipeline agents over a three-to-five-year horizon.
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Lynn Price, Rheumatology Franchise Head Spherix Global Insights 4848794284 lynn.price@spherixglobalinsights.com
