This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome
The investigators designed a single center, open-label, prospective study. Adults with active primary Sjögren's Syndrome will be enrolled, meeting the American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2016) diagnostic criteria . Tofacitinib 5 mg bd was administered for 6 months to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Tofacitinib 5mg was taken orally twice a day for 6 months
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGImmunological Responses
Analysis interleukin 17 (IL-17)-producing helper T (Th17) cells before and during tofacitinib treatment. P values below 0.05 are considered statistically significant in this study.
Time frame: week 24
Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters
ESSPRI ranges from 0 to 10. The patient's acceptability/satisfaction of its current state (taking account of his symptoms: dryness, fatigue and pain) should be recorded. For addressing patient-reported outcomes, we define response as an improvement of ESSPRI at least one point or 15% .
Time frame: week 24
Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed
we will report frequency of adverse events.Adverse events includes infection, tumor, abnormal neutrophil and lymphocyte count, anemia,drug-induced liver and kidney damage.
Time frame: up tp 24 weeks
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