Phase 2b Study of Ianalumab in Sjögren's Save

A 52-week has demonstrated the safety and efficacy of ianalumab, a dual B cell depleter) in patients with active Sjögren's disease (SjD).

The Phase 2b trial enrolled 190 SjD patients who were randomized (1:1:1:1) to either placebo or ianalumab (5, 50, or 300 mg) given subcutaneously every 4 weeks in the initial 24 week treatment period [TP]1). At week 24, patients on 300 mg were re-randomized to either 300 mg or placebo till week 52 (TP2). The endpoint measures were (ESSDAI, ESSPRI, PaGA, and PhGA.  

Of the 190 TP1 patients, 90 (47.4 %;) continued 300 mg (43) or placebo (47) and entered TP2. By week 52, efficacy ( measured by ESSDAI, ESSPRI, PaGA, PhGA) was sustained in those remaining on 300 mg in TP2. Stimulated salivary flow rates and autoantibody levels were also numerically improved in the 300 mg group. Adverse events included some with injection-site reactions and decreased neutrophil counts (grade 3 = 3 patients. 

The same drug was studied in SLE and presented at ACR24 (Abstract 2580) – 68 SLE patients were given either ianalumabor placebo for 28 weeks. Then placebo patients rolled over to active ianalumabtreatment and patients were followed out to week 68. ianalumabwas shown to be highly effective at depleting B cells, improving serologic measures and showed significant efficacy (compared to placebo) in multiple SLE outcomes – including SRI-4, SRI-6, LLDAS and DORIS.