Novartis Announces Positive Phase 3 Results for Ianalumab in Sjögren’s Disease
Novartis announced new late-breaking data from the NEPTUNUS-1 and NEPTUNUS-2 phase 3 trials evaluating ianalumab in Sjögren’s disease, the second most prevalent rheumatic autoimmune disease. The results, presented during the American College of Rheumatology (ACR) Convergence congress, demonstrated that ianalumab 300 mg administered monthly achieved clinically meaningful benefits in disease activity and patient-reported outcomes.
In both global phase 3 studies, ianalumab produced a numerically greater reduction in disease activity compared to placebo by Week 16, with improvements sustained through Week 52, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
“Sjögren’s disease is a debilitating autoimmune condition affecting multiple organs, causing dryness, fatigue, pain, and an increased risk of lymphoma – together creating a substantial disease burden,” said Professor Xavier Mariette, Head of the Department of Immuno-Rheumatology at Bicêtre Hospital, Assistance Publique – Hôpitaux de Paris, Paris-Saclay University, France. “The NEPTUNUS trials are the first phase 3 studies in Sjögren’s disease to show significant improvement in disease activity, underscoring ianalumab’s potential to bring a clinically meaningful benefit to patients.”
Novel Dual Mechanism of Action
Ianalumab is a fully human monoclonal antibody with a unique dual mechanism of action—it both depletes B cells and blocks BAFF-R signaling, thereby inhibiting B-cell activation and survival. B-cell dysfunction plays a central role in the pathogenesis of Sjögren’s disease, driving the autoimmune response, chronic inflammation, and tissue damage.
“Today’s results reinforce our confidence that ianalumab could transform the treatment of this complex disease, where no targeted therapies currently exist,” said Shreeram Aradhye, MD, President of Development and Chief Medical Officer at Novartis. “We are committed to working closely with health authorities worldwide to bring this innovation to people living with Sjögren’s disease.”
The NEPTUNUS program included 219 trial sites across 35 countries. Both NEPTUNUS-1 and NEPTUNUS-2 demonstrated statistically significant improvements in ESSDAI at Week 48, meeting the primary endpoint for ianalumab 300 mg monthly. Numerical improvements were observed as early as Week 16, and were sustained throughout the study period.
Patients receiving ianalumab experienced consistent numerical improvements across key secondary endpoints, including:
Increased number of patients achieving low disease activity (ESSDAI)
Improved Physician Global Assessment (PhGA) scores
Reduced overall disease burden from Week 8 to Week 52 as measured by Patient Global Assessment (PaGA)
Numerical improvements in dryness, fatigue, and pain according to the Sjögren’s Syndrome Symptom Diary and EULAR Sjögren’s Syndrome Patient Reported Index
Improved stimulated salivary flow rate (sSF) and reduced oral dryness compared to placebo in patients with higher baseline sSF levels
Nominal statistical significance was achieved in several pooled secondary outcomes, including PhGA, PaGA, and low disease activity achievement. Importantly, the safety profile of ianalumab was favorable, with rates of adverse and serious adverse events comparable to placebo.