The goal of this clinical trial is to learn if blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome. It will also learn about the safety of low-dose blinatumomab. The main questions it aims to answer are:
Is low-dose blinatumomab more effective in patients with moderate-to-severe primary Sjögren's Syndrome who have an inadequate response or intolerance to conventional treatment? How does blinatumomab affect B cells, antibody levels, and the immune system in these participants?
Researchers will compare background treatment plus low-dose Blinatumomab with background treatment only to see if low-dose Blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome.
Participants will:
Receive background treatment for 24 weeks, including hydroxychloroquine 400 mg each day, methylprednisolone 8 mg each day, and sodium hyaluronate eye drops 4 times each day.
If assigned to the blinatumomab group, receive blinatumomab by continuous intravenous infusion for 5 days during week 1 and again for 5 days during week 3. The dose will be 9 micrograms per day.
Attend regular follow-up visits for clinical assessments, laboratory tests, and monitoring of treatment effectiveness and safety.
Participants who voluntarily agree to comply with the study protocol and provide written informed consent.
Male or female participants aged 18 to 70 years.
Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria.
Positive anti-SSA antibody at screening.
Secondary Sjögren's syndrome.
Severe cardiovascular, hepatic, renal, respiratory, endocrine, or malignant disease, or uncontrolled acute or chronic infection.
Active and severe central nervous system manifestations related to Sjögren's syndrome.
History of stroke, epilepsy, dementia, Parkinson's disease, ataxia, cerebellar disease, psychosis, paresis, aphasia, or any other neurological condition that, in the investigator's judgment, may place the participant at excessive risk or interfere with study assessments.
Parallel
Blinatumomab
DrugParticipants will receive low-dose, short-course blinatumomab treatment. The dosing regimen is as follows: 1. First cycle: blinatumomab 9 μg/day by continuous intravenous infusion for 5 consecutive days, for a total dose of 45 μg. 2. Second cycle: the same dose and administration schedule will be repeated 1 week later.
background treatment
DrugAll the participants will receive background treatment for 24 weeks. The background treatment includes: (1) hydroxychloroquine, 400 mg/day; (2) methylprednisolone, 8 mg/day; and (3) sodium hyaluronate eye drops, 4 times/day.
NEI corneal fluorescein staining score
Corneal epithelial damage will be assessed using the National Eye Institute (NEI) corneal fluorescein staining scale. Each cornea is divided into five regions, and each region is scored from 0 to 3. The total score ranges from 0 to 15, with higher scores indicating more severe corneal epithelial damage. The outcome is calculated as the Week 24 total score minus the baseline score. A decrease of 3 points or more from baseline is defined as a response.
ESSDAI score
Systemic disease activity will be assessed using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). The ESSDAI evaluates disease activity across 12 organ or system domains and has a total score ranging from 0 to 123, with higher scores indicating greater disease activity. The outcome is calculated as the Week 24 total score minus the baseline score. A decrease of 3 points or more from baseline is defined as a response.
NEI score at follow-up visits
Corneal epithelial damage will be assessed using the National Eye Institute corneal fluorescein staining scale. The total score ranges from 0 to 15, with higher scores indicating more severe corneal epithelial damage. Changes from baseline will be assessed at each prespecified follow-up visit.
OSDI score
Dry eye symptoms and their effects on visual function and quality of life will be assessed using the 12-item Ocular Surface Disease Index (OSDI). The total score ranges from 0 to 100, with higher scores indicating more severe symptoms and greater impairment. Changes from baseline will be assessed at each follow-up visit.
FBUT
Tear film stability will be assessed using fluorescein tear film break-up time (FBUT). FBUT is measured in seconds from eye opening until the first break in the fluorescein-stained tear film is observed. Measurements will be repeated for each eye and averaged according to the study protocol. Changes from baseline will be assessed at each follow-up visit.
Schirmer I test
Tear secretion will be assessed using the Schirmer I test without topical anesthesia. A standard filter paper strip is placed in the lower conjunctival sac, and the length of wetting is measured in millimeters after 5 minutes. Changes from baseline will be assessed at each follow-up visit.
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