Etrasimod

(Velsipity®)

Velsipity®

Drug updated on 4/17/2024

Dosage FormTablet (oral; 2 mg)
Drug ClassSphingosine 1-phosphate receptor modulators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

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Summary
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  • Etrasimod (Velsipity) is indicated for the treatment of moderately to severely active ulcerative colitis in adults, showing substantial effectiveness in inducing clinical and endoscopic remission. However, it did not demonstrate a statistically significant effect in inducing histological remission.
  • Two studies provided a detailed comparison of the efficacy and safety of Velsipity relative to other treatments for ulcerative colitis, including its implications for specific population types and subgroup considerations.
  • The risk of serious infections was comparable between oral small molecule drugs such as etrasimod and placebo, indicating a favorable safety profile for this drug in the treatment of ulcerative colitis.
  • In patients with Ulcerative Proctitis (UP), a particularly symptomatic form of UC that is difficult to treat, etrasimod showed superior outcomes compared to placebo both in the induction and maintenance of remission, indicating its potential as an effective option within this challenging patient group.
  • Compared with traditional therapies like topical 5-Aminosalicylic Acid (5-ASA), conventional corticosteroids, budesonide, etc., etrasimod showed notably superior efficacy, especially in the induction phase, making it a potentially more effective treatment choice among refractory or hard-to-treat cases.
  • Both studied emphasized the need for further trials specifically focused on underrepresented populations such as those suffering from UP so that the evidence base can be expanded; this highlights the ongoing requirement for more detailed subgroup analysis aimed at fine-tuning treatment approaches within the broader UC patient population.

Product Monograph / Prescribing Information

Document TitleYearSource
Velsipity (etrasimod) Prescribing Information.2023Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses