Novartis has reported new results from two ongoing phase 3 trials evaluating ianalumab in patients with Sjögren’s disease, the second most common rheumatic autoimmune disease. The data demonstrated clinically meaningful improvements in patient outcomes, supporting ianalumab’s potential as a first targeted therapy for the condition.
Sjögren’s disease is a systemic autoimmune disorder characterised by chronic inflammation and tissue damage affecting multiple organs. Symptoms typically include dry eyes and mouth, fatigue, widespread pain, and an increased risk of lymphoma.
B-cell dysfunction is known to play a central role in driving disease pathology by triggering an autoimmune response that leads to inflammation and tissue destruction. Ianalumab, a fully human monoclonal antibody, works by depleting and inhibiting the activation of B cells, thereby addressing a key disease mechanism.
The results, first presented at the American College of Rheumatology Convergence congress, showed that a monthly 300mg dose of ianalumab achieved statistically significant and sustained improvements in disease activity compared with placebo. In both the NEPTUNUS-1 and NEPTUNUS-2 phase 3 trials, patients receiving ianalumab experienced greater reductions in disease activity by Week 16, with improvements maintained through Week 52, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
Both NEPTUNUS trials are randomised, double-blind, multi-arm pivotal studies assessing the efficacy and safety of ianalumab in patients with Sjögren’s disease. Conducted across 219 sites in 35 countries, the studies continue to follow participants, with the option to enter a long-term extension to further evaluate ianalumab’s long-term efficacy and safety.
“Today’s results reinforce our confidence that ianalumab has the potential to transform the treatment of this complex disease where no targeted medications currently exist,” said Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis. “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.”