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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
Up to 2.5 years of pooled safety data from 3 randomised, double-blind, placebo-controlled trials (one Phase II and two Phase III) and interim data from the ongoing OLE studies:3
|
PLACEBO-CONTROLLED COHORT (phase 2 and phase 3 studies)* |
All UC COHORT
(phase 2 and phase 3 , OLE)†‡§
|
||
|---|---|---|---|
| % of patients with an event (exposure-adjusted incidence rates per 100 PY) |
VELSIPITY (n=629; 288.1 PY) |
Placebo (n=314; 115.1 PY) |
VELSIPITY (n=956; 769.3 PY) |
| Any AE leading to study treatment discontinuation |
5% (0.11) | 3% (0.07) | 7% (0.08) |
| Serious AEs | 5% (0.1) | 5% (0.15) | 7% (0.09) |
| Death | 0 | 0 | 0.1% (<0.01) |
| Serious infections | 1% (0.01) | 2% (0.04) | 2% (0.02) |
| Herpes zoster | <1% (<0.01) | 1% (0.02) | 1% (<0.01) |
| Opportunistic infections** | <1% (<0.01) | <1% (<0.01) | <1% (<0.01) |
| Bradycardia | 2% (0.04) | 0% (0) | 2% (0.02) |
| AV block, first degree | <1% (<0.01) | 0% (0) | <1% (<0.01) |
| AV block, second degree (Mobitz type 1) |
<1% (<0.01) | 0% (0) | <1% (<0.01) |
| Hypertension | 2% (0.04) | 1% (0.03) | 2% (0.03) |
| Macular edema | <1% (<0.01) | <1% (<0.01) | <1% (<0.01) |
| Malignancies | 0% (0) | 0% (0) | <1% (<0.01) |
| Alanine aminotransferase increased |
2% (0.04) | 1% (0.02) | 3% (0.03) |
| Gamma-glutamyl transferase increased |
2% (0.04) | 1% (0.02) | 3% (0.04) |
| PRES | 0 | 0 | 0 |
*Placebo-controlled cohort: Patients who received either placebo or VELSIPITY as part of one Phase II study (VELSIPITY 1 or 2 mg for 12 weeks; NCT02447302) or two Phase III studies (VELSIPITY 2 mg for 12 or 52 weeks; NCT03945188 and NCT03996369).3 A total of 577 patients received VELSIPITY 2 mg/day and 52 patients received 1 mg/day.3 VELSIPITY 1 mg is not a licensed dose. The only licensed dose in the UK is 2 mg.1
†All UC cohort: All patients who received ≥1 dose of VELSIPITY (NCT02447302, NCT03945188, NCT03996369,
NCT02536404, NCT03950232, and open-label period of NCT04176588; data cutoff January 31, 2022).3
‡1 event of death occurred in the all UC cohort; this was a serious AE of neuroendocrine tumour resulting in death that was assessed by the investigator as unlikely related to study treatment. The patient received VELSIPITY 2 mg for approximately 24.3 weeks before the onset of the event.3
§No events of PRES were reported.3 However, rare cases of PRES have been reported in patients receiving S1P receptor modulators; PRES is listed as a special warning and precaution for use in the SmPC. If PRES is suspected, treatment with VELSIPITY should be discontinued.1
**Opportunistic infections were identified using the MedDRA (version 24.1) Standardised Medical Query Opportunistic Infections (narrow scope). Infections identified using this search strategy included cytomegalovirus infection and herpes simplex meningitis (2 VELSIPITY patients), and tuberculosis (1 placebo patient).3
††Bradycardia events (including MedDRA preferred terms of bradycardia and sinus bradycardia) occurred in the VELSIPITY 2 mg dose groups; no events in placebo.3
Read about the special warnings and precaustions that should be taken into account before initialising VELSIPITY treatment.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-UNP-GBR-7812. January 2024