Succesful treatment of Sjörgens - ianalumab press release

[EndME]

Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease​

Aug 11, 2025
Ad hoc announcement pursuant to Art. 53 LR

• NEPTUNUS-1 and NEPTUNUS-2 are the first ever global phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren’s disease
  
  
• Ianalumab has the potential to become the first and only targeted treatment approved for patients with Sjögren’s disease
  
  
• Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease
  
  
• Novartis plans to present its data at an upcoming medical congress and submit to health authorities globally

Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease

www.novartis.com

 

[Jaybee00]

Depletes B cells. So why does this mab work for Sjogrens while rituximab does not @Jonathan Edwards ?

 

[Utsikt]

Both trials met the primary endpoint of demonstrating statistically significant improvements in disease activity.

No mention of clinical significance. The primary endpoint of the two trials was change in ESSDAI at week 48.

ESSDAI appears to be a rating scale for clinicians. MCII is proposed as 3 here:

EULAR Sjögren's syndrome disease activity index (ESSDAI): a user guide

The EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. With the growing use of the ESSDAI, some domains appear to be more challenging to rate than others. The ESSDAI is now...

rmdopen.bmj.com

Trial registrations:

ClinicalTrials.gov

clinicaltrials.gov

ClinicalTrials.gov

clinicaltrials.gov

 

[Utsikt]

Depletes B cells. So why does this mab work for Sjogrens while rituximab does not @Jonathan Edwards ?

No idea if it’s relevant, but it seems like it has two modes of action:

Its mechanism of action targets B cells in two ways, namely combining B cell depletion via antibody-dependent cellular toxicity (ADCC) and interruption of BAFF- R mediated signals of B cell function and survival3.

 

[Jaybee00]

No mention of clinical significance. The primary endpoint of the two trials was change in ESSDAI at week 48.

This is a good point actually. For a lot of MS meds, success is defined as no further deterioration rather than improvement.

 

[Jonathan Edwards]

Depletes B cells. So why does this mab work for Sjogrens while rituximab does not @Jonathan Edwards ?

Rituximab "didn't work " in lupus trials for 20 years until somebody designed an intelligent trial. Getting a result with B cell depletion will be highly dependent on patient selection and the way the protocol pharmacidynamics suits the type disease selected.

The targeting of BAFFR may be relevant.

But Sjogrens is a very hard disease to "measure" and as said above the measures may not be that relevant to quality of life.