Novartis presented 108-week data on investigational ianalumab at the American College of Rheumatology Convergence 2026 on Nov. 10, reporting deeper disease-activity reductions and higher low-activity rates among patients receiving monthly treatment.
Among patients who continued 300 mg monthly, the mean change from core-study baseline on the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) was −7.5 points at Week 108, compared with −6.5 at Week 48. For patients who switched from placebo to monthly ianalumab at Week 60, the mean change was −6.5 points at Week 108 and −5.1 at Week 48, according to the meeting abstract.
Low disease activity, defined as an ESSDAI score below five, was recorded in 65.1% of the continuous-treatment group at Week 108, up from 57.1% at Week 48. In the group that switched from placebo, the rate rose to 60.9% from 50.4% over the same period.
The extension enrolled 610 of 666 patients who had completed up to one year in the core studies. Of those enrolled, 551 completed Week 108. Physician- and patient-reported measures, including ESSPRI and SSSD, also remained improved through Week 108. In the continuous-treatment group, patients whose baseline stimulated salivary flow was above 0.4 mL per minute still showed improvement at Week 96.
Safety was assessed through Week 204. The abstract reported no new safety findings, while Novartis said adverse-event and serious-adverse-event rates were comparable between treatment arms. The reported Week 108 efficacy results cover patients who continued monthly treatment and those who switched from placebo; they do not include a group that remained on placebo through Week 108.
Novartis said ianalumab was under regulatory review in several countries, including the United States, where a Food and Drug Administration decision was expected in 2026. The company describes the antibody as targeting B cells through depletion and BAFF-R blockade. The ongoing extension is designed to follow patients for up to six years.
