Positive Results for First Targeted Sjögren’s Treatment

The results support the potential for ianalumab, a drug with a dual mechanism of action, B-cell depletion and BAFF-R inhibition, to become the first targeted treatment for patients with Sjögren’s disease.

Sjögren’s is one of the most prevalent rheumatic autoimmune diseases, affecting approximately 0.25% of the population with an estimated 50% undiagnosed.^2-3

The results support the potential for ianalumab… to become the first targeted treatment for patients with Sjögren’s disease

The chronic, disabling autoimmune disease causes inflammation and tissue damage, impacting the entire body.^4,5,6 It primarily affects exocrine glands, leading to excessive dryness, with over 90% of patients experiencing dry eyes and dry mouth.^5,7

“Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognised or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need. Both Phase III trials demonstrate that ianalumab improves disease activity in patients with Sjögren’s disease,” said Dr Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis.

Both NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren’s syndrome disease activity index (ESSDAI), a multi-dimensional disease activity measurement compared to placebo.¹ Ianalumab was well tolerated and demonstrated a favourable safety profile in Sjögren’s disease.^8,9

References

1. Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease | Novartis United States of America. Available at com/us-en/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease Sjögren’s disease | Novartis United States of America [accessed August 2025].
2. Conrad N, Misra S, Khunti K, et al. Cambridge G. Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. Lancet. 2023 Jun 3;401(10391):1878-1890. doi: 10.1016/S0140-6736(23)00457-9.
3. Narváez J, Sánchez-Fernández SÁ, Bustabad S, et al. Prevalence of Sjögren’s syndrome in the general adult population in Spain: estimating the proportion of undiagnosed cases. Sci Rep. 2020 Jun 30;10(1):10627. doi: 10.1038/s41598-020-67462-z.
4. Dörner T, Bowman SJ, Hueber W, et al. Safety and efficacy of ianalumab in patients with sjögren’s disease: 52-week results from a randomized, placebo-controlled, phase 2b dose-ranging study. Arthritis Rheumatol. 2025 May;77(5):560-570. doi: 10.1002/art.43059.
5. Negrini S, Emmi G, Puppo F, et al. Sjögren’s syndrome: a systemic autoimmune disease. Clin Exp Med. 2022 Feb;22(1):9-25. doi: 10.1007/s10238-021-00728-6.
6. Mariette X, Criswell LA. Primary sjögren’s syndrome. N Engl J Med. 2018 Mar 8;378(10):931-939. doi: 10.1056/NEJMcp1702514.
7. Maleki-Fischbach M, Kastsianok L, Koslow M, Chan ED. Manifestations and management of Sjögren’s disease. Arthritis Res Ther. 2024 Feb 8;26(1):43. doi: 10.1186/s13075-024-03262-4.
8. Novartis data on file.
9. Bowman SJ, Fox R, Hueber W, et al. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren’s syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30. Erratum in: Lancet. 2025 Mar 29;405(10484):1056. doi: 10.1016/S0140-6736(25)00560-4.