Research in Brief

Abstract

The novel B-cell-depleting biological drug ianalumab has shown promise in the treatment of primary Sjögren's syndrome in a phase 2b, dose-finding trial by Simon Bowman and colleagues. 190 patients with moderate-to-severe disease activity and symptom severity were randomly assigned (1:1:1:1) to receive placebo (n=49) or ianalumab 5 mg (n=47), 50 mg (n=47), or 300 mg (n=47), subcutaneously every 4 weeks for 24 weeks, stratified by EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at baseline (≥10 or <10). ESSDAI scores decreased from baseline in all ianalumab groups, with the greatest change in the 300 mg group (placebo-adjusted least-squares mean change –1·92 points [95% CI –4·15 to 0·32]; p=0·092). At week 24, a dose-related change from baseline in placebo-adjusted ESSDAI scores (the primary objective) was found in four of the five dose-response models tested (p<0·025 in four models, p=0·060 in one model). Four serious adverse events were considered treatment-related, two in the placebo group (pneumonia and gastroenteritis) and two (in a single patient) in the ianalumab group (appendicitis plus tubo-ovarian abscess).