Novartis reports sustained ianalumab benefits in Sjögren’s disease study
Novartis presented interim NEPTUNUS extension data at the American College of Rheumatology Convergence 2026 on November 10, showing continued improvement in Sjögren’s disease activity through Week 108. In the group receiving ianalumab 300 mg monthly throughout, the mean ESSDAI reduction from core-study baseline reached 7.5 points, while low disease activity increased to 65.1% from 57.1% at Week 48. Participants moved from placebo to monthly ianalumab also improved, with low disease activity reaching 60.9%; safety follow-up through Week 204 identified no additional findings, according to Novartis.
Why it matters
The data provide longer-term efficacy and safety information for investors assessing ianalumab ahead of a U.S. Food and Drug Administration decision expected this year. A decision would determine whether the investigational therapy can enter the U.S. market for Sjögren’s disease.
Key facts
- 1The continuous-treatment group recorded a mean ESSDAI reduction from core-study baseline of 7.5 points at Week 108. globenewswire.com
- 2Low disease activity in the continuous ianalumab monthly group rose from 57.1% at Week 48 to 65.1% at Week 108. globenewswire.com
- 3The group that changed from placebo to monthly ianalumab had low disease activity rates of 50.4% at Week 48 and 60.9% at Week 108. globenewswire.com
- 4Adverse-event and serious-adverse-event rates were comparable between the treatment groups through Week 204, with no new safety findings reported. globenewswire.com
- 5The FDA decision on ianalumab in the United States is expected this year. globenewswire.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.