Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial

Dose-finding RCT (n=190) of this new biologic with two modes of suppressing B cells found maximal reduction in ESSDAI score (disease activity) from baseline to 24 weeks in the 300mg group (placebo-adjusted least-squares mean change −1.92 points (95% CI −4.15 to 0.32; p=0.092).

SPS commentary:

The authors note there are currently no approved therapies shown to treat or slow the progression of Sjögren’s syndrome, a complex autoimmune disease characterised by malfunction and destruction of exocrine glands. Current treatments relieve symptoms of dry eye and dry mouth, whereas treatments for more serious organ involvement are adapted from those used in other rheumatic diseases.

Ianalumab is a monoclonal antibody directed against the BAFF receptor. It suppresses B cells via two mechanisms: direct lysis by antibody-dependent cellular cytotoxicity, and BAFF receptor blockade that interrupts BAFF-mediated signalling for B-cell maturation, proliferation, and survival.

This study is the first RCT to show the ability of an anti-B-cell drug to reduce disease-activity and increase saliva flow in patients with Sjögren’s syndrome, and it identified a safe and active dose for future trials.

The Lancet