Sjögren’s Syndrome: A Common, Underrecognized Autoimmune Disorder
Sjögren’s disease is a chronic systemic autoimmune disorder that affects over 650,000 patients across the US, EU5, and Japan, with prevalence expected to rise to 700,000+ by 2030. Despite being one of the most common rheumatological diseases in adults, no disease-modifying therapies are currently approved in major markets.
Treatment remains largely off-label, with hydroxychloroquine, steroids, DMARDs, rituximab, and belimumab used to manage systemic manifestations. However, a new wave of pipeline therapies—including ianalumab, dazodalibep, and nipocalimab—is targeting the underlying pathophysiology of the disease, offering hope for more effective and targeted treatment options.
In this report we cover:
- Key growth drivers: Rising prevalence, improved diagnostics, and a robust pipeline of biologics targeting B-cell activity and immune dysregulation.
- Promising therapies: Ianalumab (Novartis), Dazodalibep (Amgen), Nipocalimab (J&J), and other emerging agents in Phase II/III development.
- Novel endpoints: Introduction of STAR and CRESS composite measures to better capture treatment response and improve trial success rates.
