NEJM publishes mixed findings from ianalumab trials in Sjögren’s disease

Published findings from two randomized trials of ianalumab for Sjögren’s disease showed small improvements in disease activity compared with placebo, while key secondary outcomes did not show clear benefit, MedPage Today reported. The study appeared in the New England Journal of Medicine.

NEPTUNUS-1 enrolled 275 patients and NEPTUNUS-2 enrolled 504. After 1 year, disease activity scores fell by an average of 6.4 and 6.5 points with monthly ianalumab, compared with 5.1 and 5.5 points with placebo. The every-3-month dosing arm showed no difference from placebo. The investigators also reported no significant differences in key secondary outcomes, including measures of symptoms. MedPage reported that Novartis has started another placebo-controlled trial, THALASSA, with a planned 570 participants and estimated primary completion in August 2029.