Pipeline Advances in Sjögren Disease Bring Targeted Therapies Closer

Two late-stage biologics in development for the US market have met their primary end points in Sjögren disease, raising the prospect of the first FDA-approved targeted therapy for a condition without any approved disease-modifying treatment.^1-3 The advances come as claims data show that patients with the disease incur health care costs that are almost 3 times that of patients without the disease.⁴

Novartis' ianalumab met its primary end point in the NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214) trials, presented at ACR Convergence 2025, and earned an FDA breakthrough therapy designation on January 16, 2026.^2,5 On September 22, Amgen reported topline results that showed its CD40 ligand antagonist dazodalibep also met its primary end point in the phase 3 OASIZ 301 trial (NCT06104124).³

Systemic Options in the Pipeline

RemeGen's telitacicept has already cleared a hurdle neither Novartis nor Amgen has: China's National Medical Products Administration approved it for Sjögren disease on June 8, 2026, which its partner Vor Bio describes as the first regulatory approval for the indication anywhere.⁶ Vor Bio is running global phase 3 trials, including one in Sjögren disease, to support potential approvals in the US, Europe, and Japan.

In NEPTUNUS-1 and NEPTUNUS-2, which randomized 275 and 504 patients, respectively, monthly ianalumab 300 mg produced a greater drop in European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) scores at week 48 than placebo.² An arm in NEPTUNUS-2 that treated patients with ianalumab once every 3 months did not yield a significantly greater mean reduction compared with placebo. Ianalumab uses a dual mechanism of action that binds to BAFF-R and depletes B cells and inhibits their activation.⁵

Amgen's dazodalibep hit its week-48 ESSDAI primary end point in OASIZ 301, which enrolled about 621 adults with moderate to severe systemic disease activity.³ Dazodalibep works by targeting immune activation to disrupt interactions between T cells, B cells, and other antigen-presenting cells. The company did not disclose numerical results in its topline release, and detailed data are expected at a future medical meeting. A second phase 3 study, OASIZ 303 (NCT06245408), in patients with high symptom burden and low systemic activity, is expected to be completed in the fourth quarter of 2026.

Treatment Centers on Symptom Relief

Management of the disease is largely symptomatic. EULAR recommendations cover saliva substitutes and artificial tears, topical therapies, and the oral muscarinic agonists pilocarpine and cevimeline, followed by systemic agents for extraglandular disease.⁷

A 2019 systematic review that informed those recommendations, covering literature through 2017, found 5 randomized trials in which pilocarpine or cevimeline improved oral dryness and salivary flow, although they enrolled patients under older classification criteria, and the authors called the evidence in patients meeting current criteria very limited.⁸ In a 120-patient randomized trial of hydroxychloroquine, the drug did not differ from placebo on a composite of dryness, fatigue, and pain.⁹ The 2 largest rituximab (Rituxan; Genentech) trials, which together randomized 255 patients, also missed their primary outcome.

Claims data suggest the lack of effective systemic therapy affects prescribing. In an analysis of MarketScan claims from 2006 to 2011 on 10,414 patients, systemic disease-modifying therapies were used mostly by patients who had another autoimmune disease, and 15.1% of patients had no Sjögren-related prescriptions at all.⁹

Symptoms of Sjögren and Diagnosis

Sjögren disease is a systemic autoimmune condition in which the immune system attacks moisture-producing glands, causing dry eyes and dry mouth. It can also cause fatigue and pain, and it can affect organs such as the kidneys, gastrointestinal tract, and lungs.¹ Nine in 10 patients are women, and the Sjögren's Foundation puts the average age at diagnosis at around 40 years, while a systematic review found averages of 40 to 67 years across studies.^1,10

The Sjögren's Foundation estimates that about 2.5 million Americans with the disease are undiagnosed.¹ Without a single test that confirms it and symptoms that can mimic or overlap with those of menopause, allergies, or other diseases, the average diagnosis time is 3 years. Diagnosis typically draws on the 2016 American College of Rheumatology/EULAR classification criteria, which incorporate anti-SSA (Ro) antibodies and objective measures such as Schirmer testing and salivary flow rates.¹⁰

Although reaching a diagnosis can be delayed, early diagnosis and treatment are critical.¹ In a study of patients meeting the 2016 criteria, those with longer diagnostic delays reported poorer general health and more physician visits than those diagnosed sooner.¹¹

Burden on Patients and the Health System

Although cost data predate any targeted therapy, a systematic literature review found mean direct costs in the US ranging from $4878 to $27,526 per patient per year, with indirect costs rarely reported.¹² A newer MarketScan analysis presented at ISPOR 2026 compared 1698 commercially insured patients with 3396 matched controls and found mean annual all-cause health care costs of $27,147 compared with $9736.⁴ Patients with Sjögren disease had higher health care resource utilization in general, including being more likely to have an emergency department visit (27% vs 19%).

There are also documented productivity losses among patients who have Sjögren disease, who averaged 66 hours of short-term disability vs 27 for controls, at a cost of $1280 vs $520, plus 18 vs 12 hours of workplace absence. The authors of the MarketScan analysis, who include Amgen employees, concluded the findings highlighted the “multifaceted burden” of Sjögren disease.

References

1. Sjögren's Foundation. About Sjögren's (fact sheet). Accessed October 1, 2026. https://sjogrens.org/sites/default/files/inline-files/About%20Sj%C3%B6grens_1.pdf
2. Johnson V. NEPTUNUS-1 and 2: monthly ianalumab significantly improves Sjögren disease activity (ACR Convergence 2025 coverage). Rheumatology Live. November 4, 2025. Accessed October 1, 2026. https://www.rheum-live.com/view/neptunus-1-2-monthly-ianalumab-significantly-improves-sjogren-disease-activity
3. Positive topline phase 3 results for dazodalibep in moderate-to-severe systemic Sjögren's disease. News release. Amgen. September 22, 2026. Accessed October 1, 2026. https://www.amgen.com/newsroom/press-releases/2026/09/amgen-announces-positive-topline-phase-3-results-for-dazodalibep-in-moderatetosevere-systemic-sjgrens-disease
4. DiRenzo D, Patel S, Kathe N, Moore-Schiltz LC, Noxon-Wood V, Kilby A. Incremental direct and indirect costs of Sjögren's disease in the United States: a retrospective analysis using MarketScan databases. Value Health. 2026;29(S6).
5. Ianalumab receives FDA Breakthrough Therapy designation for Sjögren's disease. News release. Novartis. January 16, 2026. Accessed October 1, 2026. https://www.novartis.com/news/media-releases/novartis-ianalumab-receives-fda-breakthrough-therapy-designation-sjogrens-disease
6. Telitacicept receives NMPA approval for the treatment of Sjögren’s disease in China. News release. Vor Bio. June 8, 2026. Accessed October 1, 2026. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-receives-nmpa-approval-treatment-sjogrens-disease
7. Ramos-Casals M, Brito-Zerón P, Bombardieri S, et al; EULAR-Sjögren Syndrome Task Force Group. EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020;79(1):3-18. doi:10.1136/annrheumdis-2019-216114
8. Brito-Zerón P, Retamozo S, Kostov B, et al. Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome. RMD Open. 2019;5(2):e001064. doi:10.1136/rmdopen-2019-001064
9. Birt JA, Tan YM, Mozaffarian N. Sjögren's syndrome: managed care data from a large United States population highlight real-world health care burden and lack of treatment options. Clin Exp Rheumatol. 2017;35(1):98-107.
10. Thurtle E, Grosjean A, Steenackers M, Strege K, Barcelos G, Goswami P. Epidemiology of Sjögren's: a systematic literature review. Rheumatol Ther. 2024;11(1):1-17. doi:10.1007/s40744-023-00611-8
11. Meinecke A, Kreis K, Olson P, et al. Impact of time to diagnosis in patients with primary Sjögren's syndrome: a cross-sectional study. Clin Exp Rheumatol. 2024;42(12):2444-2452. doi:10.55563/clinexprheumatol/karr2a
12. Choi J, Christodoulou A, Sreih A, et al. Economic burden and healthcare resource utilization in Sjögren's disease: a systematic literature review. Value Health. 2024;27(6):S1.