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Sjogren's syndrome (Sjögren's syndrome) is a self- immune disease characterized by dry eyes, dry mouth, symptoms and quality of life decline
.
There is currently no cure to improve the disease
Sjogren's syndrome (Sjögren's syndrome) is a self- immune disease characterized by dry eyes, dry mouth, symptoms and quality of life decline
The subjects were 18-75-year-old patients with primary Sjogren’s syndrome with moderate to severe activity (ESSDAI score ≥6 points) and severe symptoms.
They were randomly divided into four groups (1:1:1:1), each of which was divided into four groups.
Placebo or Ianalumab (5 mg, 50 mg, or 300 mg) was injected subcutaneously every week for 24 weeks
.
And stratified according to the ESSDAI score at baseline (≥10 or <10 points)
Changes in ESSDAI scores in each group
Changes in ESSDAI scores in each groupFrom June 27, 2017 to December 6, 2018, 293 patients were screened , of which 190 were randomly divided into four groups: 49 in the placebo group, 47 in the Ianalumab 5 mg group, and 47 in the Ianalumab 50 mg group.
Among them, 47 were in the Ianalumab 300 mg group
.
The researchers used a five dose-response model to examine the effect of Ianalumab of disease activity were observed in four overall disease activity dose-response models have statistical significance of the dose-response (four models p <0.
According to the screening statistics , the ESSDAI scores of all Ianalumab group patients were lower than the baseline, and the ESSDAI scores of the Ianalumab 300 mg group changed the most
Three patients had four treatment-related serious adverse reactions (1 case of pneumonia and 1 case of gastroenteritis in the placebo group; 1 case of appendicitis in the Ianalumab 50 mg group with tubal and ovarian abscess)
In summary, the study achieved its main goal.
Ianalumab can significantly improve the ESSDAI score of patients with moderate to severe Sjogren’s syndrome at 24 weeks
Original source:
Original source:Simon J Bowman, et al.
Subcutaneous ianalumab and efficacy of the Safety (VAY736) in patients with Primary Sj ö gren 'apos syndrome: A randomized, Double-Blind, Placebo-Controlled, dose-Finding Trial Phase 2B ö in this message
