Breaking News for Sjogren’s Disease: Ianalumab Phase 3 Trials Are SUCCESSFUL!
For years, those of us navigating the world of Sjogren’s Disease –– the dryness, the fatigue, the body pain, the systemic complications –– have heard the same frustrating sentence: There are no FDA-approved treatments specifically for Sjogren’s Disease.
We've managed symptoms with a patchwork of approaches, but we haven't had a targeted therapy designed to address the immune system dysfunction at the root of our disease. Today, that narrative is finally starting to change!
As a quadruple board-certified allergy, immunology, and lifestyle medicine physician, a certified life coach, and someone living with Sjogren’s Disease and dysautonomia, I am thrilled to share some incredibly exciting news with everyone tuning in.
This is the News We've Been Waiting For!
This is the kind of milestone our community has long awaited. Just this past week, we received positive Phase 3 trial results from Novartis for their medication, ianalumab!
Novartis announced that their large global Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2 (they always have such creative names!), met their primary goals. This means that in these rigorous scientific studies, ianalumab showed a statistically significant improvement in disease activity for Sjogren’s Disease patients compared to those who received the placebo medication.
This is the first time ever that a medication has shown this level of success in a Phase 3 clinical trial for Sjogren’s Disease. It's a monumental step and paves the way for ianalumab to potentially become the very first FDA-approved targeted treatment for our condition.
The Science Behind Ianalumab: A Dual Action Approach
Let’s take a quick dive into how this medication works and what makes ianalumab so special. It has a clever, dual mechanism of action:
B-cell Depletion: In Sjogren’s, a type of immune cell called the B-cell plays a major role in the autoimmune attack. Ianalumab helps remove some of these overactive B-cells that are causing problems in the system.
BAFF-R Inhibition: It also blocks a key survival signal for B-cells called BAFF by targeting its receptor (BAFF-R). This is like cutting off the fuel supply to these cells. Without this signal, B-cells cannot fully develop and produce the autoantibodies that are a main source of the inflammation driving Sjogren’s Disease.
By tackling the problem in these two ways, ianalumab offers a powerful approach to calming that misguided immune response causing Sjogren’s symptoms. The best part? The press release also noted that ianalumab was well-tolerated and had a favorable safety profile in these trials. This is crucial, as we always weigh risks and benefits when considering any medication.
What This Means for Our Sjogren's Community
This isn't just a win for Novartis (though I suspect their stock prices might be happy!). This is a win for us. It's a win for every person who has felt dismissed, struggled to find relief, and waited patiently (or not so patiently!) for science to catch up to our needs.
Validation: An FDA-approved treatment sends a powerful message to the entire medical community that Sjogren’s is a serious systemic disease deserving targeted, effective treatments – just like rheumatoid arthritis, lupus, or myasthenia gravis.
A New Tool: It gives doctors and patients an evidence-based option to manage the disease itself, not just the symptoms.
Spurring More Research: Success breeds success! This milestone will likely encourage even more investment in research for other potential Sjogren’s Disease therapies.
The Road to FDA Approval: What Happens Next?
Novartis plans to present the full data from these trials at an upcoming medical conference. After that, they will submit their findings to health authorities like the FDA here in the United States and similar bodies worldwide for the approval process.
This process takes time, but ianalumab has already been granted Fast Track designation by the FDA, which can help speed that bureaucratic process along a bit. We'll be watching very closely for updates!
A Personal Reflection from a Trial Participant
As many of you know, I'm currently participating in a different Phase 3 clinical trial for Sjogren’s (the OASIZ trial for Dazodalibep). This news about ianalumab fills me with so much hope. It reinforces why participating in research is incredibly important. It's because of the hundreds of patients who volunteered for the NEPTUNUS-1 and -2 trials that we are at this pivotal moment today.
This news strengthens my resolve and my passion for helping all of you navigate this journey. It's a reminder that we're not just managing a condition; we are part of a community actively pushing for a better future. (If you want to learn more about my thought process and updates on my own trial journey, check out my prior episodes linked below!)
Join the Movement & Get Support!
The development of ianalumab and other emerging therapies offers immense hope for the Sjogren’s community. This journey isn't easy, but you're not alone. I’m here to support you, and there's a wonderful, growing community walking this path alongside us.
Connect: Join the Success with Sjogren's Sisterhood Facebook group (open to all genders – sisterhood is the vibe!) for resources and connection.
Tools: Download my free Sjogren's Superhero Starter Kit, packed with valuable tips and resources.
Personalized Care: I'm also accepting new patients in my direct care practice, the Immune Confident Institute. If you've been on the fence about starting your journey with us, our pricing will be updated on September 1st, so you have about two weeks left to book your consultation at our current legacy pricing! (Links to learn more and schedule are below.)
What are your thoughts on this incredible news? How does it make you feel about the future of Sjogren's treatment? Share your excitement, hesitations, or questions in the comments below!
