Ianalumab in Sjögren's Disease: NEPTUNUS-1 and -2
Two phase 3 trials (779 patients) tested ianalumab, a B-cell-depleting antibody that also blocks BAFF-R, in active Sjögren’s disease. Monthly 300 mg reduced ESSDAI more than placebo at week 48, by 1.3 points in NEPTUNUS-1 (P = 0.0496) and 1.0 point in NEPTUNUS-2 (P = 0.04), and every-3-months dosing did not. The hierarchy then broke: ESSDAI response and symptom scores did not differ, so the secondary results cannot support causal claims, and the placebo groups improved a great deal.