Efficacy and Safey of Ianalumab in Sjogren’s Disease

In this segment, the panel reviews the most recent clinical data for ianalumab, a BAFF receptor inhibitor that both blocks B-cell signaling and promotes B-cell depletion, targeting a core mechanism of Sjögren’s Disease (SjD). They discuss results from the NEPTUNUS-1 and NEPTUNUS-2 phase 3 trials, presented at ACR Convergence 2025, which evaluated ianalumab in patients with moderate to severe systemic disease. The trials demonstrated statistically significant improvements in composite disease activity scores and meaningful reduction in glandular and systemic symptoms compared with placebo. Importantly, patients also showed signals of potential stabilization of salivary gland function, a key step toward true disease modification.

Regarding safety, the panel notes that adverse events were generally manageable and consistent with the mechanism of action, with no unexpected safety concerns reported. While longer-term follow-up is still needed, the group highlights that these findings represent one of the most promising therapeutic advances to date in SjD.