New Therapy for Sjögren Disease on the Horizon

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New Therapy for Sjögren Disease on the Horizon

Novartis unveiled phase 3 results for ianalumab, a first-in-class, dual-action monoclonal antibody targeting Sjögren disease, the second most common rheumatic autoimmune disorder. Presented at the American College of Rheumatology’s 2025 Convergence congress, data from the NEPTUNUS-1 and NEPTUNUS-2 trials (820 patients, 35 countries) showed that treatment with monthly subcutaneous ianalumab 300 mg led to a clinically meaningful, sustained drop in systemic disease activity by week 48—meeting the trial’s primary endpoint. Benefits emerged by week 16 and persisted to week 52.

Patients reported rapid, consistent relief in dryness, pain, and fatigue from week 8 onward, with pooled nominal significance. Those with higher baseline stimulated salivary flow (analogous to residual lacrimal reserve) experienced preserved glandular function and less oral dryness, implying parallel protection of tear production. Mechanistically, ianalumab depletes pathogenic B cells while blocking BAFF-R signaling, dismantling the autoimmune infiltrate that destroys lacrimal acini.

There were no excess infections, infusion reactions, or malignancies over 52 weeks. Regulatory filings are slated for 2026, with clinic availability expected in late 2027 or early 2028.

In short, ianalumab is poised to become the first disease-modifying therapy for Sjögren disease, sparing thousands from progression to filamentary keratitis, corneal melts, and lifelong serum-drop dependence.

My Two Cents

This is extremely exciting! Currently, there aren’t many treatment options available for our Sjögren patients, and these are often my most challenging dry eye patients. Every single aspect of their life seems to be affected by the disease. Currently, we only have XyliMelts (Oral Science) and pilocarpine to help patients produce more saliva/liquid. For pain, we have hydroxychloroquine, and for gland swelling, there is off-label rituximab (Rituxan, Genentech). In short, nothing great. If this becomes available, I look forward to seeing how much it could help so many of our patients with Sjögren disease.

OUTSIDE THE LANE

How to Beat SAD This Winter

As daylight shrinks and winter looms, seasonal affective disorder (SAD) strikes 5% of US adults with full-blown clinical depression—far beyond the winter blues. Patients feel hopeless, oversleep, overeat, and lose joy in once-loved activities. The root cause: Less sunlight throws the body’s master clock off-kilter, delaying the melatonin shutoff. Thus, mornings still feel like midnight.

The simplest, most potent antidote is free and fits any schedule: a brisk morning walk within 2 hours of sunrise. Stepping outside before 10 AM floods the retina with 10,000 to 100,000 lux—50-times brighter than an average therapy box—snapping melatonin production off like a switch and yanking the circadian rhythm back to summer settings. Bonus: The exercise itself spikes endorphins and slashes anxiety.

University of Vermont psychologist Kelly Rohan, PhD, a 20-year SAD researcher, calls it “the single most potent non-drug tool we have.” Psychiatrist Sue Varma, MD, PC, DFAPA, adds: “Tell your brain, ‘Hey, wake up!’” Even on cloudy days, outdoor light trumps indoor lamps. January and February hit hardest, but dread often creeps in by November.

Starting the habit now prevents the plunge. Here are some tips to help you stick with it:

• Dress in layers, leash the dog, grab earbuds—whatever helps motivate you.
• Aim for 30 minutes at a pace that makes chatting slightly hard.
• Pair with TODAY’s free 30-day walking plan inside the Start TODAY app for daily cues and community.
• If mornings are impossible, a 10,000-lux box for 20 to 30 minutes at breakfast is a solid plan B.

One patient told Dr. Rohan, “I thought I needed pills; I just needed sunrise.” Make the sidewalk your waiting room—your mood will thank you by Thanksgiving.

My Two Cents

As we enter autumn and our days start to get shorter, many of our patients will begin to experience SAD. Research and news about this disorder are right up our alley as eye doctors, as it even includes the amount of lux that typically hits the retina when outside before 10 AM. It makes sense that getting out there first thing in the morning and getting the blood flowing would help patients both physically and mentally. I have found that working out first thing in the morning, although tough to get excited about, is one of the best ways to get my body and mind ready for the day.

CAN YOU RELATE

Dinner meeting fatigue. Is it just me, or does there seem to be two to three industry dinners happening every week? Just this week in little ‘ole Baton Rouge, Louisiana, we have three different dinner meetings! Now, don’t get me wrong; I love the occasional free meal and socializing with my friends and colleagues—and I do a fair amount of speaking at these dinners!  Heck, during November I’ll be speaking at four of them in four different cities.

First, we need to highlight some of the positive attributes of these meetings; they are invaluable to help doctors learn about the latest pharmaceuticals that have hit the market. In addition, we sometimes learn about different tools that can assist us in our clinic. All in all, these dinners are highly effective, and word has clearly spread about how they help companies increase awareness of their products and improve their bottom line. The effectiveness has obviously spread to all areas of eye care, and it’s easy to see the dinner meeting fatigue setting in among my colleagues. I’ve heard it from doctors in my own office! “Jeezzzz, another dinner? My spouse is going to kill me if I miss another night at home.”

Here’s the main point of this “Can You Relate” section: We are taking time away from our busy schedules to learn about things that will undoubtedly make our patients’ lives better, and yet we’re not allowed to have a pharma company buy us a drink? Ever since the COVID-19 pandemic, the pharmaceutical companies have been under a tight leash by government overseers, and they are not allowed to provide alcohol to their attendees. We are all adults with advanced degrees. I see nothing wrong with attendees at one of these dinner meetings wanting to have an Old Fashioned, a cold beer, or a nice glass of red wine. As one of our most esteemed doctors once put it, “Davidson…you’re not going to get me to one of those dinners. I need two of three things to be there. I’ve gotta be able to get me a steak, some CME, and some wine. If I don’t get two of the three, I won’t be coming.”

QUOTE OF THE WEEK

“The dinner hour is a sacred, happy time when everyone should be together and relaxed.”

- Julia Child