Cardiovascular Deaths, Baricitinib Data Highlight Systemic Sjögren Disease

Baricitinib vs hydroxychloroquine on ESSDAI response in active Sjögren disease

Baricitinib 4 mg daily produced a higher rate of clinically meaningful improvement in systemic disease activity than hydroxychloroquine in patients with active Sjögren disease, according to an open-label randomized trial presented at the ACR Convergence 2026, held November 6-11 in Orlando, Florida.¹,² A separate national analysis presented at the meeting found cardiovascular deaths among US decedents with Sjögren disease rose by approximately 50% over 2 decades.³

Sjögren disease has no approved therapy targeting systemic involvement, and earlier data suggested the Janus kinase (JAK) inhibitor baricitinib (Olumiant) might benefit these patients.¹ The American College of Rheumatology (ACR) highlighted both abstracts together, noting meeting abstract findings are preliminary and not yet peer reviewed.²

The investigator-initiated, multicenter trial enrolled 87 patients aged 18 to 75 years meeting the 2016 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria with an EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score of at least 5 at 8 hospitals in China between July 2022 and May 2024.¹ Patients were randomized 2:1 to baricitinib 4 mg daily (n = 58) or hydroxychloroquine 400 mg daily (n = 29) for 24 weeks, and hydroxychloroquine nonresponders switched to baricitinib at week 12.¹

In the intention-to-treat population, 63.8% (37/58) of patients receiving baricitinib achieved minimal clinically important improvement (MCII) in ESSDAI at week 12, the primary endpoint, compared with 34.5% (10/29) receiving hydroxychloroquine (P = .010).¹ Patients lost to follow-up or discontinuing treatment were counted as nonresponders.¹

Baricitinib secondary outcomes, safety, and cardiovascular mortality in Sjögren syndrome

In per-protocol analyses of 49 baricitinib-treated and 24 hydroxychloroquine-treated patients, median physician global assessment changed by −0.60 (interquartile range [IQR], −1.10 to −0.40) vs −0.40 (IQR, −0.65 to 0.00) (P = .027).¹ Median rheumatoid factor changed by −19.60 (IQR, −96.00 to 1.10) vs 0.00 (IQR, −13.80 to 17.55) (P = .007).¹

Adverse events (AEs) occurred in 8 patients receiving baricitinib and two receiving hydroxychloroquine, with no serious AEs reported.¹ The abstract did not report results for ESSPRI, the Sjögren's Tool for Assessing Response (STAR), or exocrine gland function, and the open-label design and small sample size limit interpretation.¹

The second study, a CDC WONDER analysis by Anam Naseem, MD, and colleagues at Mercy Catholic Medical Center, identified 1558 cardiovascular deaths among decedents with Sjögren syndrome from 1999 to 2020.³ Annual deaths fell from 68 in 1999 to 46 in 2006, then rose to 123 in 2020, and deaths increased 50.3% between 1999-2003 (n = 318) and 2016-2020 (n = 478).³

Women accounted for 98.4% of decedents, and the West (31.3%) and South (29.3%) carried the largest share of deaths.³ Counts for Black, Hispanic, and American Indian or Alaska Native decedents were suppressed because of small numbers, and the analysis used crude counts rather than age-adjusted mortality rates.³

"Understanding which populations bear a disproportionate cardiovascular mortality burden, while simultaneously advancing rigorously tested treatment options for active disease, is essential to improving outcomes for people living with Sjögren disease," said Naseem.²

"Patients with active Sjögren disease need treatment strategies supported by high-quality clinical evidence," said Xiaofeng Zeng, MD, professor, Department of Rheumatology and Immunology, Peking Union Medical College Hospital.²

The baricitinib abstract will be presented as poster 0421 and the mortality abstract as poster 0805 on November 8, 2026, during Poster Session A.¹,³ Follow Rheumatology Live's full ACR Convergence 2026 coverage here.

REFERENCES:
1. Bai W, Leng X. Efficacy and safety of baricitinib in active Sjögren disease: a multicenter, randomized, controlled trial. Presented at: ACR Convergence 2026; November 6-11, 2026; Orlando, FL. Abstract 0421. https://acrabstracts.org/abstract/efficacy-and-safety-of-baricitinib-in-active-sjogren-disease-a-multicenter-randomized-controlled-trial/
2. American College of Rheumatology. New ACR Convergence 2026 research highlights cardiovascular mortality disparities and promising baricitinib results in Sjögren disease. Published November 7, 2026. Accessed November 7, 2026. https://rheumatology.org/press-releases/new-acr-convergence-2026-research-highlights-cardiovascular-mortality-disparities-and-promising-baricitinib-results-in-sjogren-disease
3. Naseem A, Pitliya A, Anwar U, et al. Cardiovascular mortality among decedents with Sjögren syndrome in the United States, 1999-2024: temporal trends and demographic disparities. Presented at: ACR Convergence 2026; November 6-11, 2026; Orlando, FL. Abstract 0805. https://acrabstracts.org/abstract/cardiovascular-mortality-among-decedents-with-sjogren-syndrome-in-the-united-states-1999-2024-temporal-trends-and-demographic-disparities/