New Sjogren’s Treatments: Who Will Benefit?

On January 30, the Sjogren's Foundation's 2026 State of Sjogren’s CME Conference featured six new drugs currently in clinical trials. The presenters expressed optimism that one or more of these medications would be approved soon by the FDA for use in Sjogren's. In this post, I share highlights from the conference and discuss how clinical studies might impact Sjogren’s care going forward.   CME Conference-Continuing Medical Education programs that provide updates for clinicians.

The 2025 Patient Survey

The conference opened with Janet Church, Sjögren's Foundation President & CEO, giving a sneak preview of the 2025 Sjögren’s Foundation Patient Survey results. The survey results demonstrated high impact of Sjogren's on quality of life, primarily due to fatigue, pain, and neurocognitive impacts. The top quality of life impacts, in order, were: 1. Fatigue

2. Joint pain 3. Brain fog 4. Dry eyes 5. Sleep problems I look forward to reviewing the detailed survey results when they are published on the Sjögren’s Foundation website.

Review of Potential New Medications

An expert panel featuring Drs. Sara McCoy, Ghaith Noaiseh, and Alan Baer reviewed clinical trials for six emerging Sjogren’s treatments and the specific immune pathways they target. The medications discussed included Deucravacitinib, Dazodalibep, Ianalumab, Nipocalimab, Efgartigimod, and Telitacicept.

The primary endpoint for these trials was a reduction in the ESSDAI (EULAR Sjogren’s Syndrome Disease Activity Index), the standard research tool for measuring systemic disease activity. Thus far, several of the new drugs have demonstrated success in lowering ESSDAI scores.

The Dazodalibep was unique in that it enrolled a group of high symptom burden patients alongside moderate-high ESSDAI patients, and made fatigue a primary endpoint. Early results demonstrated a significant reduction in fatigue, a top priority for most patients.

 

The following section summarizes the insights shared by the expert panel, followed by my analysis and commentary.  

1. New treatments are expected to be approved soon.  It is unclear who will be eligible to try the new treatments once they are approved. It is possible their use may be limited to SSA-positive patients with moderate-high ESSDAI scores.   My Comments: Lowering the ESSDAI score is an important goal. High ESSDAI scores are associated with problems like damage to the lungs and kidneys, vasculitis, and lymphoma. It is understandable that clinical studies would start with a well-defined group and use a standardized research tool like the ESSDAI. These trials can help raise awareness of the systemic nature of Sjogren's disease, which is still widely misunderstood as a sicca syndrome. The presenters did not discuss the limitations of the ESSDAI as a reflection of disease severity or activity. They did not acknowledge that patients with a low ESSDAI score often have a high burden of systemic disease that goes unrecognized because:

• Highly prevalent systemic manifestations—including autonomic disorders like POTS, cognitive dysfunction ("brain fog"), gastrointestinal issues, and Raynaud’s phenomenon—are frequently excluded from clinical research because they are excluded by the ESSDAI. Despite their profound impact on quality of life, these problems, caused directly by Sjogren’s, are often overlooked by researchers and clinicians simply because they do not appear on the "official" checklist.

  
  

• Systemic features are sometimes misattributed to other conditions. Joint involvement may be labeled as osteoarthritis. Core systemic features, including dysautonomia, fatigue, and cognitive dysfunction ("brain fog") are often assumed to be psychological in origin. Patients with muscle inflammation and small fiber neuropathy are often told their symptoms are caused by fibromyalgia.   

• Clinical evaluations often miss systemic manifestations, even when they are part of the ESSDAI. For instance, small fiber neuropathy requires specific testing that is often overlooked, and early-stage lung or kidney involvement are frequently not recognized until advanced.
  

2. Enrollment criteria exclude most Sjogren’s patients. 

Only about 30% of Sjogren’s patients meet the enrollment criteria for these studies, which means they do not represent the broader Sjogren’s patient population. Current studies focus SSA-positive patients with high B-cell activity, which is associated with blood markers such as high IgG, positive rheumatoid factor (RF), low complement, and cryoglobulins. My Comments: Strict enrollment requirements are often used in clinical trials to create “cleaner” patient groups, making them more likely to get FDA approval. This is often a good strategy, especially for a disease that has had no prior FDA-approved drugs. However, it is important to acknowledge the need for future studies to focus on high symptom burden patients (many of whom are SSA-negative) with an ESSDAI score less than 5. New studies should make quality of life outcomes, especially fatigue, pain, and cognitive dysfunction a major focus.  

3. SSA-negative patients While select trials are starting to include a small number of SSA-negative participants, sample sizes are not large enough to show outcomes in this group.   My Comments: The presenters acknowledged that SSA-negative patients my have different pathways leading to the disease, but did not mention any effort to define those pathways. This reflects an ongoing failure to address this large subset (at least 30%) of patients.

They failed to note that SSA-negative patients can experience nearly every systemic manifestation found in SSA-positive cases. Clarifying this in CME programs is essential, as the misconception persists that SSA-negative Sjogren’s is a milder form of the disease. This is why some rheumatologists refuse to diagnose SSA-negative patients, while others incorrectly tell them that they don't need to be followed or treated.

SSA-negative patients have higher rates of joint, neurological, and GI involvement and similar rates of lung disease. They also have worse fatigue and pain on average, and more extreme delays in diagnosis. The ongoing underrepresentation of SSA-negative patients in basic research and clinical trials creates a vicious cycle of underdiagnosis and undertreatment.  

4. Tools for measuring treatment outcomes Some of the drug trials are expanding beyond the ESSDAI to use newer tools called STAR and CRESS, which include patient reported outcomes such as fatigue, pain, and dryness.

My Comments: The STAR and CRESS tools paint a broader clinical picture but still fall short. They do not remedy the problem of excluding dysautonomia, cognitive dysfunction ("brain fog"), gastrointestinal issues, and Raynaud’s phenomenon, from clinical trials.

5. Overlooking dysautonomia My Comments: The presenters never mentioned dysautonomia, despite its high prevalence in Sjogren’s (estimated at 50% or more) and its strong correlation with fatigue, cognitive dysfunction, and work disability. To help patients feel and function better, clinicians must routinely screen for and manage autonomic disorders in their Sjogren’s patients. The current medical system does not offer clinicians support or training to do this.

Summary

New therapies for Sjogren’s are nearing approval. While it is too early to know who might qualify for these drugs, it is possible that they will be restricted to patients with high systemic involvement based on the ESSDAI score.

This highlights a persistent disconnect: the most debilitating features of Sjogren’s are not represented well by the ESSDAI. To bridge this gap, research tools must evolve to capture and address the true spectrum of the disease beyond the ESSDAI, and include manifestations such as dysautonomia, cognitive impairment, gastrointestinal issues, and Raynaud’s.

Uses and Limitations of the ESSDAI