Adverse Events| Safety | Velsipity® (Etrasimod)

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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

Velsipity (etrasimod): Summary of safety profile¹

47% (112/238) of patients in the VELSIPITY arm and 47% (54/116) of patients in the placebo arm reported adverse events
3% (6/238) of patients in the VELSIPITY arm and 2% (2/116) of patients in the placebo arm reported serious adverse events

47% (112/238) of patients in the VELSIPITY arm and 47% (54/116) of patients in the placebo arm reported adverse events
3% (6/238) of patients in the VELSIPITY arm and 2% (2/116) of patients in the placebo arm reported serious adverse events

The safety profile of VELSIPITY was studied in two Phase III, randomised, double-blind, placebo-controlled studies*²

The most common adverse reactions with VELSIPITY are lymphopenia (11%) and headache (7%)¹

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ADVERSE REACTIONS OBSERVED WITH VELSIPITY
System organ class	Very Common (≥1/10)	Common (≥1/100 to <1/10)	Uncommon (≥1/1,000 to <1/100)
Infections and infestations		Urinary tract infection,† lower respiratory tract infection ‡
Blood and lymphatic system disorders	Lymphopenia^§	Neutropenia
Metabolism and nutrition disorders		Hypercholesterolaemia**
Nervous system disorders		Headache, dizziness
Eye disorders		Visual impairment	Macular oedema
Cardiac disorders		Bradycardia††	Atrioventricular block ‡‡
Vascular disorders		Hypertension
Hepatobilliary disorders		Hepatic enzyme increased

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Within each system organ class and frequency groups, adverse reactions are presented in order of decreasing seriousness¹.

ELEVATE UC 52²

71% (206/289) of patients in the VELSIPITY arm and 56% (81/144) of patients in the placebo arm reported adverse events
7% (20/289) of patients in the VELSIPITY arm and 6% (9/144) of patients in the
placebo arm reported serious adverse events

ELEVATE UC 12²

47% (112/238) of patients in the VELSIPITY arm and 47% (54/116) of patients in the placebo arm reported adverse events
3% (6/238) of patients in the VELSIPITY arm and 2% (2/116) of patients in the placebo arm reported serious adverse events

47% (112/238) of patients in the VELSIPITY arm and 47% (54/116) of patients in the placebo arm reported adverse events
3% (6/238) of patients in the VELSIPITY arm and 2% (2/116) of patients in the placebo arm reported serious adverse events

47% (112/238) of patients in the VELSIPITY arm and 47% (54/116) of patients in the placebo arm reported adverse events
3% (6/238) of patients in the VELSIPITY arm and 2% (2/116) of patients in the placebo arm reported serious adverse events

ELEVATE UC 52²

*The safety set included all randomised patients who received ≥1 dose of study treatment. For this set, patients were analysed according to the treatment received, regardless of randomisation.³
^†Urinary tract infection includes urinary tract infection and cystitis.¹
^‡Lower respiratory tract infection includes bronchitis and pneumonia.¹
^§Lymphopenia includes lymphopenia, lymphocyte count decreased, and lymphocyte percentage decreased.¹
**Hypercholesterolaemia includes hypercholesterolaemia and blood cholesterol increased.¹
^††Bradycardia includes bradycardia and sinus bradycardia.¹
^‡‡Atrioventricular block includes first- or second-degree Mobitz type I.¹

Pooled and Interim safety data

Get to know the comprehensive pool VELSIPITY safety data.

VIEW POOLED AND INTERIM SAFETY DATA NOW

47% (112/238) of patients in the VELSIPITY arm and 47% (54/116) of patients in the placebo arm reported adverse events
3% (6/238) of patients in the VELSIPITY arm and 2% (2/116) of patients in the placebo arm reported serious adverse events

UC – ulcerative colitis.

References:

1. VELSIPITY Summary of Product Characteristics
2. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171
3. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171 (supplementary appendix)

Safety Profile

PP-V1A-GBR-0021. September 2024

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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