This study is designed to explore the efficacy and safety of upadacitinib and clarify the influence on immune function in the treatment of primary Sjögren's Syndrome.
Male or female >18 years of age at screening visits
Participants with diagnosis of pSS according to the 2016 ACR/EULAR criteria
Participants have an ESSDAI score ≥ 5
Participants must be on a stable dose of prednisone (≤10mg/day), antimalarials or equivalent, and cholinergic stimulants prior to Baseline.
Pregnant or breastfeeding female.
Diagnosis of other autoimmune disease, or other sicca syndrome.
Parallel
Upadacitinib (ABT-494)
DrugUpadacitinib 15mg Qd for 52 weeks
Hydroxychloroquine (HCQ)
DrugHydroxychloroquine 200mg Bid for 52 weeks
Treatent response assessed by the Sjögren's Tool for Assessing Response (STAR)
STAR is a new response assessment tool for pSS including 5 aspects: systemic activity, patient-reported outcomes, lacrimal gland function, salivary gland function, and biomarkers, which can evaluate treatment response in all patients with pSS, including those with low systemic activity but high symptom burden. Response in system activity (3 points) is defined by a decrease of ≥3 in clinESSDAI and response in patient-reported outcome (3 points) is defined by a decrease of ≥1 point or 15% in ESSPRI. Response in lachrymal gland function (1 points) is assessed by Schirmer's test or ocular staining score. Response in Salivary gland function (1 points) was assessed by unstimulated whole salivary flow or ultrasound. Biological response (1 points) means decrease of serum IgG level ≥10% or decrease of RF level ≥25%. Candidate STAR responder is defined by total score of the above 5 domains ≥5.
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score during treatment
ESSDAI measures the disease activity of primary Sjögren's Syndrome from 12 aspects: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, biological involvement. The score of each domain is obtained by multiplying the activity level by the domain weight, and the weight range is 1 to 6, and a numerical score is assigned according to the weight of each domain determined in advance. The sum of all single weighted domain scores is the total score, ranging from 0 ( best ) to 123 ( worst ). The higher the score, the stronger the disease activity. A clinically significant decrease ( ≥ 3 points ) compared with the baseline indicates an improvement in symptoms.
Change From Baseline in EULAR SS patient-reported index (ESSPRI) during treatment
ESSPRI was developed to assess patients' symptoms in primary Sjögren's Syndrome. It Includes three main symptoms, dryness, pain, and fatigue, and each with a score range of 0-10, and the ESSPRI score is the average of the three scores. A higher score indicated more severe symptoms.
Variation of lymphocyte subpopulations during the treatment of upadacitinib
Lymphocyte subgroups of T cell and B cell are analyzed during the treatment.
Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib
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