Justin Cooper , 2025-04-17 09:30:00
April 17, 2025
6 min read
Research into Sjögren’s disease — both analyzing the condition itself and testing potential treatments — has come a long way in the past decade.
“Fifteen years ago, we had no clinical trials, no pharma interest in Sjögren’s, and we were starting to see lupus trials fail one after the other,” Kathy M. Hammitt, vice president of medical and scientific affairs at the Sjögren’s Foundation, told Healio.
Now, thanks to the efforts of researchers in partnership with advocacy groups, there are now five potential therapies currently in phase 3 trial evaluation, any one of which may soon become the first ever FDA-approved drug to treat Sjögren’s disease.
According to Hammitt, Sjögren’s disease is more common — impacting as many as 3.1 million adults in the United States alone, with more than 90% being women — and more serious “than some rheumatologists recognize.”
“Sjögren’s disease can be very debilitating, causing dysfunction and destruction of all the moisture-producing glands in the body, which can lead to dry eyes and dry mouth,” she said. “As if this wasn’t hard enough, it can cause incapacitating fatigue and pain, and it can also affect any organ or body system.”
U.S. Rep. Joseph Morelle, D-New York, recently introduced a resolution to the U.S. House of Representatives expressing support for April as Sjögren’s Awareness Month — first established in 1998 — recognizing it as “a serious health issue that causes a significant health burden.” In conjunction, the Sjögren’s Foundation is running its annual awareness campaign and sharing patients’ personal stories so the disease can be better understood.
Healio sat down with Hammitt, who is herself a patient with Sjögren’s disease, to learn more about the current landscape of Sjögren’s research and what the Sjögren’s Foundation is doing to raise awareness. The interview has been edited for length and clarity.
Healio: Is there a particular theme or message behind this year’s awareness campaign?
Hammitt: One of our major focuses this year is to amplify the voices of those living with Sjögren’s. We want to encourage others to learn more and get involved, so every day in April we’re sharing a patient’s story. On our campaign webpage, people can read personal stories from patients, test their knowledge with a Sjögren’s quiz and access social media tools to help spread awareness throughout the month.
Healio: What is the current state of research into Sjögren’s?
Hammitt: We’ve come a long way, and we still have a long way to go, but I feel like we have more hope than ever before.
For example, we’ve long known that the immune system is involved in the development of Sjögren’s, but recently we’ve been learning more about how the nervous system is involved and the interplay between the immune and nervous systems. Understanding the pathology is really critical to finding new ways to treat any disease, and this is true of Sjögren’s.
A big initiative that our foundation plays an active role in is with the NIH’s Accelerating Medicines Partnership Autoimmune and Immune-Mediated Diseases (AMP AIM) program. What is so unique about AMP AIM is that they’re taking a fresh look at four selected autoimmune rheumatic diseases — lupus, rheumatoid arthritis, Sjögren’s and psoriasis/psoriatic arthritis.
They are taking each down to the most basic molecular level and then seeing what is similar and what is different. This could provide knowledge that will greatly change what we know about these diseases and even how we define them. Traditional approaches just have not worked. They have not led to solutions for these diseases, so discarding what we think we know and then venturing outside the proverbial box is the only way to break new ground. This is one of the most major shifts and exciting things in research, I feel, to happen in our disease.
Another area is in biomarkers, which are proteins that can be found in the blood, the tissue, the urine, saliva, which really take us into the era of precision medicine. If we learn what these biomarkers mean, we can use them to understand risk factors for an individual patient, and just as importantly, we’ll know what a particular patient is not at risk of developing.
Sara S. McCoy, MD, PhD, at the University of Wisconsin, has identified an important potential biomarker, and that has not been validated yet, but that would change our success with diagnosis.
We’re also focused on better recognition of, and help for, patients who don’t fit in a straightforward diagnostic box. For years, a number of patients have fallen through the cracks because Sjögren’s is not easy to diagnose. Diagnosis is still largely an art, and many patients who are indicative of having Sjögren’s, but don’t have the key biomarker that’s linked with Sjögren’s, might not be taken seriously, and so they’re not monitored and managed.
These patients also need treatment, but they’re rarely included in clinical trials, so we need to better define who these patients are. Are their symptoms, complications and risk factors different? Are they similar? This is a big area for research now.
We might not have the answers now, but we understand what our research needs are and the challenges that patients face. This is why scientific research is so critical to our future and making a difference in patients’ lives.
Healio: What is the usual approach to treating Sjögren’s? Are there any promising new therapies on the horizon?
Hammitt: We have never had an FDA approved therapy for Sjögren’s — never — and I can’t emphasize that enough.
Traditionally, patients have been given things like corticosteroids. That’s like hitting the disease with a sledgehammer when a more targeted, precision medicine approach would be much smarter. We borrow medications from other diseases, but they haven’t been approved in Sjögren’s patients.
Fifteen years ago, we had no clinical trials, no pharma interest in Sjögren’s, and we were starting to see lupus trials fail one after the other. We wanted to address those barriers to success to ensure that trials didn’t similarly fail in Sjögren’s. With solid trial design, a therapy should prove efficacious or not efficacious based on its own merits. So, we formed an international clinical trials consortium to address those barriers.
We now have five potential therapies in phase 3 clinical trials — nipocalimab (Johnson & Johnson), deucravacitinib (Sotyktu, Bristol Myers Squibb), dazodalibep (Amgen), ianalumab (Novartis) and efgartigimod (Argenx). We are just so excited. And, of course, there are more in earlier-phase trials and in the pipeline now that target different actions in the cascade of immune events. That can only be good for the clinician and the patient.
One issue we face is that most trials target only the most severe patients. Although these patients of course need a therapy, most Sjögren’s patients are in desperate need of a treatment. They might have crippling fatigue, pain and peripheral and autonomic neuropathies, which is considered in the trade as more “moderate” disease, but they still face a devastating impact on their quality of life, and they want treatments, as well. So, we are paying much more attention to these patients than we have ever before.
Healio: What should more rheumatologists understand about Sjögren’s disease?
Hammitt: First and foremost, Sjögren’s is much more common than most rheumatologists think. Many rheumatologists tell us, “Oh, we have no Sjögren’s patients,” but this is because they’re not looking for it. It’s actually the second most common autoimmune rheumatic disease, just behind or potentially even with rheumatoid arthritis.
We urge rheumatologists to look for Sjögren’s in all their autoimmune disease patients, because more than any other such disease, Sjögren’s occurs in conjunction with other autoimmune diseases — especially, for example, in lupus patients. We estimate that about half of Sjogren’s patients have Sjögren’s alone, but the other half have at least one other autoimmune disease.
We also hope rheumatologists will recognize that although some Sjogren’s patients have dryness right from the onset, many do not. This is oftentimes a key trigger for diagnosing Sjögren’s in the rheumatologist’s mind. Many patients can take many years to develop dryness, and if you ask a patient if they’re dry, they might not realize it. Did you know that you have to lose half of your saliva before you subjectively feel dry and would use the word “dry” to describe your mouth?
The best thing a rheumatologist can do is validate the fact that the patient doesn’t feel well. Reassure the patient that, even if you might not be able to definitively diagnose them yet, you understand that they don’t feel well and, together, you’ll stay on top of their symptoms and monitor them until the patient gets a diagnosis.
Our foundation is currently working on evaluation and monitoring tools for the patient who might have Sjögren’s, providing screening and good practices that will get the clinician and patient further on the road to a proper diagnosis.
References:
Recognizing the significance of Sjögren’s disease as a serious and systemic autoimmune disease and expressing support for the designation of April 2025 as “Sjögren’s Awareness Month”, HR 245, 119th Cong, 1st Sess (2025).
Helmick CG, et al. Arthritis Rheum. 2008;doi:10.1002/art.23177.
Sjogren’s syndrome: Symptoms & treatment. https://my.clevelandclinic.org/health/diseases/4929-sjogrens-syndrome. Published Oct. 2, 2023. Accessed April 9, 2025.
For more information:
Kathy M. Hammitt can be reached at khammitt@sjogrens.org.