Ianalumab for the Treatment of Patients with Sjögren's Disease.

Ianalumab at 300 mg monthly significantly reduces disease activity in patients with active Sjögren's disease compared to placebo at week 48.

• Why it matters: Sjögren's disease currently lacks approved targeted therapies, making effective treatments a critical unmet need for managing disease activity and symptoms.
• What they did: Two 52-week, double-blind, randomized, placebo-controlled trials involving 779 patients assessed the effects of ianalumab, measuring changes in ESSDAI, SSSD, and ESSPRI scores.
• The result: Ianalumab led to a greater decrease in ESSDAI scores than placebo with a difference of -1.3 and -1.0 points in the two trials, but no significant differences were observed in response rates or symptom scores, and adverse events were similar across groups.