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Click here for VELSIPITY▼ (etrasimod) Prescribing Information. Adverse event reporting can be found at the bottom of the page.
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VELSIPITY is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.1
ELEVATE UC 52
ELEVATE UC 12
Tab Number 3
Tab Number 4
Tab Number 5
VELSIPITY delivered observable reductions in inflammation in ELEVATE UC 52,
further demonstrating the effectiveness of treatment1
Endoscopic improvement among induction clinical responders in ELEVATE UC 52 (post hoc analysis)1
Adapted from Vermeire S et al. 2023.1
Limitations: Results from this prespecified post hoc analysis should be evaluated with
caution as head-to-head, randomised trials provide the most reliable comparative efficacy evidence. This post hoc analysis was conducted at Week 52 approximating to responder
re-randomisation study design among patients who did or did not achieve clinical
response at the end of the 12-week induction period in ELEVATE UC 52.1,2
*Endoscopic improvement was defined as an endoscopy score ≤1 (excluding friability).3
†Clinical response is defined as a ≥2-point and a ≥30% decrease in baseline in a modified Mayo score and a ≥1-point decrease from baseline in an RB subscore or an absolute RB subscore ≤1.3
CI – confidence interval; RB – rectal bleeding.
References:
Significantly more patients achieved mucosal healing (endoscopic improvement with histological remission) with VELSIPITY vs placebo in ELEVATE UC 521,2
Mucosal healing was defined as ES ≤1 (excluding friability) with histologic remission (Geboes Index score <2.0,
indicating no neutrophils in the epithelial crypts or lamina propria, no increase in eosinophils, and no crypt destruction, erosions, ulcerations or granulation tissue).1
CI – confidence interval; ES – endoscopy score; UC – ulcerative colitis.
References:
1. VELSIPITY Summary of Product Characteristics.
2. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171.
See corticosteroid-free clinical remission data with VELSIPITY vs placebo.
VELSIPITY delivered observable reductions in inflammation in the colon in ELEVATE
UC 12, further demonstrating the effectiveness of treatment1
Significantly more patients achieved mucosal healing (endoscopic improvement with
histological remission) with VELSIPITY vs placebo in ELEVATE UC 121
Mucosal healing was defined as ES ≤1 (excluding friability) with histologic remission (Geboes Index score <2.0, indicating no neutrophils in the epithelial crypts or lamina propria, no increase in eosinophils, and no crypt destruction, erosions, ulcerations or granulation tissue).1
CI – confidence interval; ES – endoscopy score; UC – ulcerative colitis.
Reference:
1. VELSIPITY Summary of Product Characteristics.
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