IANALUMAB (VAY736) SAFETY AND EFFICACY IN PATIENTS WITH SJÖGREN’S SYNDROME: 52 WEEK RESULTS FROM A RANDOMIZED, PLACEBO-CONTROLLED, PHASE 2B DOSE-RANGING TRIAL
Authors: Thomas Dörner et al.
Ianalumab (VAY736) is a human monoclonal antibody to B-cell activating factor receptor, engineered for direct ADCC-mediated B-cell depletion. A Phase 2b study evaluated the dose-response of VAY736 vs placebo in Sjögren’s syndrome. 190 patients were randomized equally to receive s.c. doses of VAY736 (5, 50, 300 mg) or placebo every 4 wks (q4w).
Ianalumab 300 mg was well tolerated up to 52 wks. Continuous dosing of 300 mg s.c. q4w provided sustained clinical benefit. Stimulated whole salivary flow at wk 24 was improved for 300 mg (placebo-adjusted change from baseline 0.20 ml/min; P=0·037); last measurement at wk 48 was 0.45 and 0.22 ml/min change from baseline in patients who continued 300 mg or placebo, respectively. Efficacy was partially lost for patients who switched to placebo at wk 24. Patient global assessment was the outcome that showed the most prominent change following switch to placebo or VAY736.
The data from this study justifies phase 3 trials of ianalumab in Sjögren’s syndrome.