BASEL (dpa-AFX) - Novartis AG (NVS, NOVN.SW) on Tuesday reported encouraging two-year results from its ongoing Phase 3 NEPTUNUS extension study of investigational drug ianalumab, showing further improvements in Sjögren's disease activity through Week 108.
Among patients who continued receiving ianalumab 300 mg monthly, the mean reduction in systemic disease activity, measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), increased to 7.5 points from the core-study baseline. The proportion achieving low disease activity rose from 57.1% at Week 48 to 65.1% at Week 108.
Patients who switched from placebo to monthly ianalumab at Week 60 also showed improvements. Their mean ESSDAI reduction reached 6.5 points at Week 108, while the low disease activity rate increased from 50.4% to 60.9%.
Improvements in physician- and patient-reported outcomes and symptoms were sustained among patients continuing treatment. Improvements in stimulated salivary flow were also maintained through Week 96 in patients with baseline flow above 0.4 mL/min.
Adverse event and serious adverse event rates were comparable between the two treatment groups through Week 204, with no new safety findings.
Ianalumab is a fully human monoclonal antibody designed to deplete B cells and inhibit their activation and survival through BAFF-R blockade. The drug is being investigated for several immune-mediated diseases, including Sjögren's disease.
Novartis said ianalumab is under regulatory review in multiple countries, including the United States, where an FDA decision is expected this year. The company noted that no treatment options are currently approved for Sjögren's disease outside China.
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