Bowman SJ, Fox R, Dörner T, et al. - Findings showed good tolerability and safety of ianalumab (a new biologic) in patients with primary Sjögren's syndrome, and its use did not increase infections. Primary objective was met in this study demonstrating a dose-related reduction in disease activity as determined by ESSDAI [European Alliance of Associations for Rheumatology [EULAR] Sjögren's Syndrome Disease Activity Index] at week 24. This is the first large, randomised, controlled trial in primary Sjögren's syndrome that met its primary endpoint.

• Ianalumab (VAY736) has previously shown preliminary efficacy in treating Sjögren's syndrome.

• In this randomized controlled trial (VAY736A2201), 190 patients aged 18–75 years with primary Sjögren's syndrome were included to evaluate the safety and efficacy of different subcutaneous doses of ianalumab.

• Patients underwent randomization: placebo n=49, ianalumab 5 mg n=47, ianalumab 50 mg n=47, ianalumab 300 mg n=47.

• Change in ESSDAI score, from baseline to 24 weeks, in all randomly assigned patients was the primary outcome.

• In four of the five dose-response models tested, there were statistically significant dose-responses for overall disease activity (ESSDAI score).

• All ianalumab groups showed reduction in the ESSDAI score relative to baseline, with the maximal ESSDAI score change from baseline noted in the ianalumab 300 mg group: placebo-adjusted least-squares mean change from baseline −1·92 points.

• Treatment-related four serious adverse events occurred in three patients (pneumonia [n=1] and gastroenteritis [n=1] in the placebo group; appendicitis plus tubo-ovarian abscess in the same patient in the ianalumab 50 mg group).