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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
See VELSIPITY's efficacy data
Clinical remission
VELSIPITY helped calm uncontrolled UC symptoms, with significant clinical remission* vs placebo at Weeks 12 and 52 (P<0.001) in ELEVATE UC 521
Endoscopic improvement
Endoscopic improvement† was observed in significantly more patients treated with VELSIPITY vs placebo at Weeks 12 and 52 (P<0.001) in ELEVATE UC 521
Corticosteroid-free remission
Corticosteroid freedom was observed in 100% of patients who achieved clinical remission at Week 52 for at least 12 weeks immediately prior to Week 52‡1
Isolated proctitis
ELEVATE UC 52 and ELEVATE UC 12
included patients with isolated proctitis (provided they met all other eligibility criteria);2 enrolment of patients with isolated proctitis was capped at 15% of total population3
Biologic and JAKi Subgroup Data
Clinical remission was assessed
as part of a subgroup analysis across biologic or JAKi naïve and experienced subgroups at both Weeks 12 and 52 in ELEVATE UC 521,4
Induction responders
Clinical remission at Week 52 among
Week 12 induction clinical responders was assessed as part of a post hoc analysis of ELEVATE UC 525
Symptomatic response
Symptomatic response within the first 28 days was assessed as part of a post hoc analysis of of ELEVATE UC 52 and ELEVATE UC 12§6
Bowel urgency
Effect on bowel urgency was assessed as part of a post hoc analysis of ELEVATE UC 52**7
Read about the trial designs investigating VELSIPITY.
* Clinical remission was defined as a stool frequency subscore of 0 (or of 1 with a ≥1 point decrease from baseline), a rectal bleeding subscore of 0, and an endoscopy score ≤1 (excluding
friability).1
† Endoscopic improvement was defined as an endoscopy score ≤1 (excluding friability).1
‡ Corticosteroid-free clinical remission was defined as clinical remission at Week 52 without receiving corticosteroids for at least 12 weeks immediately prior to Week 52.1
§ Symptomatic response was defined as patients with a ≥30% change from baseline decrease in pMMS.6
** Clinically meaningful improvement in bowel urgency defined as ≥3-point decrease from baseline in BU NRS.7
References:
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PP-UNP-GBR-7812. January 2024