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TOPLINE:

Treatment with anifrolumab (Saphnelo) was associated with numerically higher improvements than placebo in multiple disease activity measures, supporting the rationale for targeting the type 1 interferon pathway in Sjögren disease.

METHODOLOGY:

• ANISE-II was a phase 2a, randomized, double-blind, single-center, placebo-controlled trial that evaluated the efficacy and safety of the type 1 interferon receptor blocker anifrolumab in Sjögren disease.
• To be included, participants had to meet the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) classification criteria for Sjögren disease.
• Inclusion criteria also included a duration of disease of 10 years or less, anti-SSA autoantibodies, EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score and/or EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score of ≥ 5, and agreement to undergo repeated parotid gland biopsies. They also could not be taking immunosuppressive drugs, hydroxychloroquine, or > 10 mg prednisone.
• Of the 30 participants, 20 received anifrolumab at a dose of 300 mg given via intravenous injection every 4 weeks, and the other 10 were given a matching placebo.
• The primary endpoint was the proportion of people achieving a Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS) response at week 24. Key secondary endpoints included Concise Sjögren’s Tool for Assessing Response (cSTAR), (Clin)ESSDAI/ESSPRI, and safety.

TAKEAWAY:

• At week 24, a total CRESS response was seen in 80% of anifrolumab-treated and 30% of placebo-treated participants, giving a between-group difference of 50%.
• Among key secondary endpoints, all individual components of CRESS were achieved by a higher percentage of anifrolumab-treated vs placebo-treated participants, and more anifrolumab-treated vs placebo-treated participants were cSTAR responders (75% vs 20%) and reached a minimally clinically important improvement in ClinESSDAI (75% vs 30%) and ESSPRI (70% vs 30%).
• There were no major safety issues and no treatment discontinuations during the trial.
• Histologic analyses of biopsies showed a decrease from baseline to week 24 in myxovirus resistance protein A, which is known to be induced by type 1 interferon, in the acini of parotid glands in the majority of clinical responders to treatment with anifrolumab vs placebo. However, there was no change in focus score or area of infiltration between the groups.

IN PRACTICE:

“Further translational research is ongoing to explore the mechanism of action of anifrolumab in patients with Sjögren disease,” said study investigator Hendrika Bootsma, MD, PhD, of University Medical Center Groningen, Groningen, Netherlands.

György Nagy, MD, PhD, DSc, of Semmelweis University, Budapest, Hungary, additionally observed: “It was especially interesting for me that pain and fatigue was also decreased, so there is a beneficial effect for anifrolumab treatment.”

SOURCE:

Bootsma reported the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting (abstract OP002).

LIMITATIONS:

Limitations of the study include its small sample size. However, this was a proof-of-mechanism trial, and further studies are now needed.

DISCLOSURES:

The study was supported by a research grant from AstraZeneca. Bootsma acknowledged receiving grants or consultancy fees from Argenx, AstraZeneca, BMS, Novartis, and Roche. Nagy was not involved in the study.