A first-line advanced treatment*1
*Advanced therapies include S1P receptor modulators, biologics, and JAKi.3
One pill, once daily, same dose1
No boxed warning1
Contraindicated in patients with specific cardiovascular conditions. Select Warnings & Precautions: Infections, Bradyarrhythmia & AV Conduction Delays, Liver Injury. See USPI.1
AV=atrioventricular.
Which of your patients with moderate to severe UC may be ready for this first-line advanced treatment*?
*Advanced therapies include S1P receptor modulators, biologics, and JAKi.3
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Trial Design1,3: Adult patients with moderately to severely active ulcerative colitis (an mMS of 5 to 9) were randomized to VELSIPITY or placebo in 2 randomized, multicenter, double-blind, placebo-controlled, phase 3 trials after an inadequate response, a loss of response, or an intolerance to ≥1 predefined UC therapies (oral aminosalicylates [5-ASAs], corticosteroids, thiopurines, JAKi, and biologics) (N=741). A modified Mayo score (an mMS of 0 to 9) consists of stool frequency (0 to 3), rectal bleeding (0 to 3), and findings on a centrally read endoscopy score (0 to 3). Primary analyses were conducted at week 12 and at week 52 in UC-1 and at week 12 in UC-2. Concomitant use of stable doses of oral aminosalicylates and/or oral corticosteroids (≤20 mg/day prednisone, ≤9 mg/day budesonide, or equivalent steroid) was permitted. Concomitant therapies not permitted were immunomodulators, biologic therapies, JAKi, rectal 5-ASAs, or rectal corticosteroids.
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VELSIPITY may increase the susceptibility to infections. Life-threatening and rare fatal infections have been reported in association with other sphingosine 1-phosphate (S1P) receptor modulators. Before starting VELSIPITY, obtain a recent (i.e., within 6 months) CBC, including lymphocyte count. Delay initiation of VELSIPITY in patients with an active infection until the infection is resolved. Consider interruption of treatment with VELSIPITY if a patient develops a serious infection. Continue monitoring for infections up to 5 weeks after discontinuing VELSIPITY.
VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.