Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; 2 mg) |
| Drug Class | Sphingosine 1-phosphate receptor modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Velsipity (etrasimod) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of advanced oral small molecules for inflammatory bowel disease: Systematic review and meta-analysis. | 2023 | Journal of Crohn's & Colitis |
| Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis. | 2023 | Alimentary Pharmacology & Therapeutics |