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September 26, 2025
3 min read
Key takeaways:
- Researchers have been aggressively targeting B cells in recent Sjögren’s studies.
- The current Sjögren’s pipeline has inspired optimism among researchers.
HUNTINGTON BEACH, Calif. — After decades of trials into pathways that ultimately failed in Sjögren’s disease, recent efforts targeting B cells have inspired optimism, according to a presenter at the 2025 Congress of Clinical Rheumatology West.
“There are a lot of challenges in treatment development in Sjögren’s disease, but there is hope on the horizon,” said Matthew C. Baker, MD, MS, associate division chief of immunology and rheumatology at the Stanford University School of Medicine.
“I do think it’s very likely that we’ll have something approved within the next few years,” said Matthew C. Baker, MD, MS. Image: Jason Laday | Healio Rheumatology.
“We are maybe on the cusp of something great, and I think we’ve learned that fundamentally targeting B cells seems to be very important,” he added. “Hopefully as the field continues to develop and refine these endotypes we’ll be able to more precisely treat these patients. We still don’t know if these therapies that are going to hopefully help systemic disease are going to do anything for symptoms that patients care about, and that’s a huge issue, but I do think it’s very likely that we’ll have something approved within the next few years.”
This represents a fundamental shift in outlook regarding the Sjögren’s landscape compared with 10 years ago, according to Baker.
“We have to look at what has failed,” he said. “This is several decades of work with people studying TNF inhibitors, interleukin-6 receptor inhibitors, CTLA4-Ig, along with many other things like IL-1, et cetera, and really they all failed.”
However, recent trials have offered more fertile ground for optimism, Baker said. He highlighted work using the CD40 ligand antagonist dazodalibep (Horizon Therapeutics) by St. Clair and colleagues, published in Nature Medicine in June 2024. The researchers assessed the drug — which targets B- and T-cell interaction, as well as other facets of autoimmunity — in two cohorts with Sjögren’s disease, both of which met their primary endpoints of ESSDAI and ESSPRI change from baseline.
Baker additionally discussed nipocalimab (Johnson & Johnson) and efgartigimod (Argenx), both of which target the neonatal Fc receptor. In the phase 2 DAHLIAS study presented at EULAR 2024, Gottenberg and colleagues assessed the efficacy and safety of nipocalimab in a cohort of 163 patients with Sjögren’s disease. According to the researchers, the nipocalimab 15 mg/kg group bested placebo in terms of change from baseline clinESSDAI.
Meanwhile, attendees at EULAR 2025 heard data from Peene and colleagues regarding efgartigimod in 30 patients with Sjögren’s. According to the researchers, the drug met the primary endpoint with 45.5% of patients in the treatment group meeting CRESS criteria at week 24, compared with 11.1% in the placebo group.
Teclistamab (Tecvayli, Janssen), a bi-specific T-cell engager that acts on T cells
through CD3 and plasma cells via BCMA, has also demonstrated promising results in Sjögren’s disease, according to Baker. He highlighted data presented at ACR Convergence 2024, and published as correspondence in the New England Journal of Medicine, on four patients with multidrug resistant autoimmune disease treated with teclistamab, one of which had Sjögren’s. In that patient, disease activity assessed via ESSDAI index improved from 34 to 15.
Looking ahead, Baker noted the volume of active trials ongoing in Sjögren’s disease, including 18 non-cellular investigational studies listed on Clinicaltrials.gov as of September, as well as 17 cellular studies. He additionally pointed out that, among the 17 cellular studies listed on Clinicaltrials.gov, 15 are based in China.
“Not trying to make any major statement here, but just to highlight there is a lot going on in China and not that much going on here, at least with Sjögren’s,” Baker said. “There is just a ton trials of cell-based therapies. Mostly they are targeting CD19 or BCMA, or both, so, again, they are just really going after the B cells.”
For more information:
Matthew C. Baker, MD, MS, can be reached at rheumatology@healio.com.
Sources/Disclosures
Source:
Baker MC. Sjögren’s disease: Are there effective treatment options? Presented at The Congress of Clinical Rheumatology West; Sept. 18-21, 2025. (hybrid meeting).
Disclosures:
Baker reports receiving research support from AbbVie, Amgen, Eli Lilly & Co., Gilead, GlaxoSmithKline, Horizon Therapeutics, Kinevant, Principia, Sanofi, Viela Bio and Zenas BioPharma, as well as consulting fees from Alumis, Amgen, AnaptysBio, Annexon Biosciences, Argenx, Dren Bio, Flatiron Bio LLC, Gilead, Halia Therapeutics, Horizon Therapeutics, Kinevant, Nesos, Neurocrine, Ouro Medicines, Progentec Diagnostics, Sanofi and Zenas BioPharma.
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