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A monthly dose of ianalumab beat placebo in reducing Sjögren's disease activity over 48 weeks across two large phase 3 trials, offering a potential first targeted therapy for a condition with no approved options. The benefit was statistically significant but clinically small, and patient-reported symptom scores didn't show significant differences.
A monthly dose of ianalumab beat placebo in reducing Sjögren's disease activity over 48 weeks across two large phase 3 trials — the NEPTUNUS-1 and NEPTUNUS-2 studies — published in the New England Journal of Medicine. This is notable because Sjögren's disease currently has no approved targeted therapies, despite years of failed or inconclusive trials with biologics.
Ianalumab works through a dual mechanism: it depletes B cells via enhanced antibody-dependent cellular cytotoxicity and blocks B-cell survival by targeting the BAFF receptor. The 300 mg monthly dose was tested in nearly 800 patients combined across both trials, with disease activity measured by the ESSDAI score. The results were promising but tempered — the drug reduced disease activity scores significantly, yet failed to show meaningful differences in patient-reported symptom outcomes or ESSDAI response rates.
By the Numbers:
Why it matters: Sjögren's disease affects millions and has long lacked targeted treatment options. While ianalumab's effect size is modest and symptom scores didn't improve significantly, these trials mark a meaningful step toward a potential first approved therapy — and will likely fuel ongoing regulatory and clinical discussions.
