Novartis presented new ianalumab data in Sjogren disease at a late-breaker presentation during the American College of Rheumatology Convergence congress.

According to a company press release, ianalumab 300 mg monthly delivered a clinically meaningful benefit in the global NEPTUNUS-1 and NEPTUNUS-2 phase 3 trials, showing both improvement in disease activity and reductions in patient burden.

Compared to placebo, ianalumab, a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and also inhibits their activation and survival via BAFF-R blockade, achieved a numerically greater reduction in disease activity by Week 16 with improvements sustained through Week 52 as measured by the EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI). 

The replicate NEPTUNUS trials showed statistically significant improvement in ESSDAI, the primary endpoint, at week 48 for ianalumab 300 mg monthly. Numerical improvements were observed as early as Week 16, which were sustained throughout the study, the company said. 

According to Novartis, patients receiving ianalumab showed consistent numerical improvements in secondary outcome measures including: more patients with ESSDAI low disease activity; improvement in Physician Global Assessment; reduction in overall disease burden as early as Week 8 continuing to Week 52 as assessed by Patient Global Assessment; and numerical improvement in dryness, pain and fatigue as assessed by Sjogren’s Syndrome Symptom Diary and EULAR Sjogren’s Syndrome Patient Reported Index. In addition, researchers saw an improvement of stimulated Salivary Flow (sSF) rate and oral dryness vs placebo in patients with sSF>0.4 mL/min at baseline, in a post-hoc analysis. 

Additionally, ianalumab 300 mg monthly numerically improved physician- and patient-reported outcomes. Nominal significance was observed in NEPTUNUS-1 and the pooled data set for PhGA and PaGA, as well as the number of patients achieving low disease activity based on ESSDAI in the pooled data set. The pooled and individual patient-reported secondary outcomes did not reach statistical significance, the company said.

The trial results showed favorable safety with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies, the company noted.