On August 11, 2025 Novartis made a groundbreaking announcement; here are some highlights from their company press release1:
· NEPTUNUS-1 and NEPTUNUS-2 are the first ever global phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren’s disease.
· Ianalumab has the potential to become the first and only targeted treatment approved for patients with Sjögren’s disease.
· Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease.
· Novartis plans to present its data at an upcoming medical congress and submit to health authorities globally [including the U.S. FDA and Health Canada].
The Neptunus Phase III randomized, double-blind, multi-center clinical trials tested ianalumab against a placebo in nearly 800 people with Sjögren’s. The studies’ main goal was to see if ianalumab would reduce disease activity, as measured by the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI), after about a year of treatment. The ESSDAI, used by clinicians and researchers, includes twelve domains such as central and peripheral nervous systems and constitutional, glandular and haematological organ systems.
NEPTUNUS-1 evaluated the treatment given once a month, while NEPTUNUS-2 studied both monthly and once every three months dosing. In a pooled analysis of more than 600 participants given monthly injections of ianalumab or a placebo across both studies, the average ESSDAI score dropped by an average of 6.5 points for those given ianalumab and 5.3 points for those on the placebo after one year. A significant difference between the ianalumab and placebo groups was evident after about four to six months of treatment and persisted for the duration of the trial.
Key secondary goals in the NEPTUNUS studies were to assess changes in scores on the Patient’s Global Assessment and the Physician’s Global Assessment, which are patient- and clinician-rated measures of overall health. Again, pooled data from both trials showed that ianalumab-treated patients had significantly greater score reductions reflecting health improvements on both measures. In the patient-reported measure, a significant difference between the ianalumab and placebo groups was detected as early as eight weeks (about two months) after starting treatment. Patients felt that the treatment really improved their quality of life, and physicians found there was numerical improvement in other patient-reported outcomes.
Ianalumab is designed to reduce the activity of B-cells, the immune cells that make antibodies in Sjogren’s disease. The therapy, given by under-the-skin injections, works by simultaneously blocking a signaling molecule that promotes B-cell survival and marking the cells for destruction.
The therapy also significantly improved salivary flow in the subset of participants who still maintained salivary function at the study’s start. Those with reduced salivary flow did not show improvement with ianalumab, which may be due to extensive, irreversible damage to their salivary glands, suggesting that ianalumab may be able to slow disease progression2.
Safety data showed rates of adverse and serious adverse events were similar among participants given ianalumab or placebo. According to Novartis, they will be pursuing regulatory submissions for ianalumab worldwide, including with Health Canada, in early 2026.
References
- https://www.globenewswire.com/news-release/2025/10/29/3176619/0/en/Novartis-ianalumab-first-drug-to-reduce-disease-activity-and-patient-burden-in-Sjgren-s-disease-Phase-III-trials.html
- Sjögren’s News, Sjögren’s treatment ianalumab shows rapid disease relief in trials, November 5, 2025
