Novartis reports a 7.5-point decline in Sjögren’s disease activity after 108 weeks of treatment
Key Facts
Novartis announced long-term results on Nov. 10, 2026, from the NEPTUNUS extension study of ianalumab in patients with Sjögren’s disease at the American College of Rheumatology meeting. At week 108, the data showed a mean 7.5-point reduction in the ESSDAI disease activity index in the group continuing monthly treatment, compared with baseline in the core study. The mean reduction was 6.5 points among patients who switched from placebo to monthly ianalumab. The company said the reductions continued to deepen with longer treatment. The results put extended follow-up of response at the center of the announcement, while Novartis said a U.S. Food and Drug Administration decision on the drug is expected this year.
Improvement also extended to the proportion of patients who achieved a reduction in disease activity. In the group continuing monthly ianalumab, the proportion rose from 57.1% at week 48 to 65.1% at week 108. In the group that switched from placebo to monthly treatment at week 60, the proportion increased from 50.4% at week 48 to 60.9% at week 108. The comparison reflects changes in the proportions between the two specified measurement points in the study, with treatment starting at different times in the two groups. Novartis said disease activity reduction rates continued to rise during follow-up.
The company said improvement in stimulated salivary flow continued through week 96 in the group continuing monthly treatment. This description covered patients whose salivary flow exceeded 0.4 mL per minute at baseline. The measure adds follow-up of another manifestation of the disease to the activity results recorded through ESSDAI. The reported data did not specify a figure for the improvement in salivary flow, and the reported continued improvement was limited to the defined patient group. On safety, Novartis said rates of adverse events and serious adverse events were comparable between the treatment arms through week 204, and that it had observed no new safety findings.
The extension results follow two pivotal Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2. NEPTUNUS-1 evaluated a 300 mg monthly subcutaneous dose of ianalumab against placebo for 52 weeks, while NEPTUNUS-2 compared monthly dosing and dosing every three months with placebo for up to 52 weeks. Novartis said both trials met their primary objective of reducing disease activity, and that it planned to submit the drug to health authorities globally in early 2026. The studies included 219 sites in 35 countries, according to the company. Novartis had previously announced completion of regulatory applications in the United States, Europe, China and Japan, with the FDA granting the drug breakthrough therapy designation and priority review.
Novartis says ianalumab is a fully human monoclonal antibody that targets B cells by depleting them and inhibiting their activation and survival through blockade of the BAFF-R receptor. The company is also studying the drug for immune thrombocytopenia, systemic lupus erythematosus, lupus nephritis and systemic sclerosis. Regarding unmet treatment needs, the company said targeted therapies are needed to address systemic Sjögren’s disease activity, and that approved treatment options for this activity are currently unavailable outside China. The extension results remain part of the drug’s clinical and regulatory dossier, as the company awaits the FDA decision expected during 2026. The Nov. 10 announcement did not include a new approval or a final regulatory decision.