Biologic Treatment of Primary Sjogrens with Ianalumab Save
Clinical trials generally fail in Sjögren's syndrome; but now a study shows that a biologic B cell inhibitor, ianalumab, met its primary endpoint with a dose-related decrease in disease activity (measured by ESSDAI) at week 24.
This was a phase II, dose-finding trial, aimed to assess the safety and efficacy of different subcutaneous doses of ianalumab in patients with moderate to severe primary Sjögren's syndrome. The primary endpoint of the study was the EULAR Sjögren's Syndrome Disease Activity Index [ESSDAI] at week 24.
Patients with primary Sjögren's syndrome and moderate to severe disease activity (ESSDAI score ≥6) were randomlized to either subcutaneous placebo or 3 doses of ianalumab (5 mg, 50 mg, or 300 mg) every 4 weeks for 24 weeks.
A total of 190 patients were treated. Significant dose-responses were seen for overall disease activity (ESSDAI score) in four of the five dose-response models tested (p<0·025 in four models). Serious adverse events were seen in in three patients (pneumonia, gastroenteritis on PBO and appendicitis plus tubo-ovarian abscess on ianalumab 50 mg).
This is the first large controlled trial in showing biologic efficacy in primary Sjögren's syndrome; futher trials are warranted with ianalumab.