Novartis has presented new data to demonstrate the effectiveness of ianalumab in treating Sjögren’s disease (previously called Sjögren’s syndrome).1 The complex, systemic autoimmune disease impacts the entire body, primarily affecting exocrine glands, leading to excessive dryness, with over 90% of patients experiencing dry eyes and dry mouth.2

Ianalumab 300 mg monthly delivered a clinically meaningful benefit in 219 replicate NEPTUNUS-1 and NEPTUNUS-2 Phase 3 trials across 35 countries, showing statistically significant improvement in disease activity and reductions in patient burden.1 Compared to placebo, ianalumab achieved a numerically greater reduction in disease activity by week 16 with improvements sustained through Week 52 as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).1

“Sjögren’s disease is a debilitating autoimmune condition affecting multiple organs, causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma – that together may create a substantial disease burden,” said Professor Xavier Mariette, Head of Department of Immuno-Rheumatology, Bicêtre Hospital, and Professor of Rheumatology at Université Paris-Saclay. “The NEPTUNUS trials were the first Phase 3 studies in Sjögren’s in which a treatment significantly improved disease activity and demonstrated that ianalumab has the potential to provide a clinically meaningful benefit to patients.”

Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade.2 B-cell dysfunction plays a significant role in Sjögren’s disease by causing an autoimmune response that leads to inflammation and tissue damage.2

Dr Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis said the “results reinforce our confidence that ianalumab has the potential to transform the treatment of this complex disease where no targeted medications currently exist”.

“We look forward to working with health authorities globally to bring this innovation to people with Sjögren’s disease, the second most prevalent rheumatic autoimmune disease.”

The data was presented at the American College of Rheumatology Convergence Congress.1

References

1. Grader-Beck T, Mariette X, Finzel S, et al. Ianalumab demonstrates significant reduction in disease activity in patients with Sjögren’s disease: Efficacy and safety results from two global Phase 3, randomized, placebo-controlled double-blind studies (NEPTUNUS-1 and NEPTUNUS-2). Presented at the American College of Rheumatology (ACR) Congress; October 24-29, 2025; Chicago, Illinois

2. Novartis, Novartis ianalumab first drug to reduce disease activity and patient burden in Sjögren’s disease Phase III trials, (media release 29 Oct 2025) available at: novartis.com/news/media-releases/novartis-ianalumab-first-drug-reduce-diseaseactivity-and-patient-burden-sjogrens-disease-phase-iii-trials [accessed Oct 2025].