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Trial Design

Klinisk remission vid ulcerös kolit

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Velsipity säkerhetsprofil

VELSIPITY demonstrated a favorable safety profile

Pooled analysis of data from 3 randomized, double-blind, placebo-controlled phase 2 and phase 3 trials and interim data from the ongoing OLE studies demonstrated mostly mild to moderate AEs for up to 2.5 years¹:

Sammanfattning av negativa händelser och avbrytningsfrekvenser i ELEVATE UC 52 och UC 12

	ELEVATE UC 52		ELEVATE UC 12
Patients, n (%)	Placebo (n=144)	Etrasimod (n=289)	Placebo (n=116)	Etrasimod (n=238)
Any adverse events	81 (56)	206 (72)	54 (47)	112 (47)
Any serious adverse events	9 (6)	20 (7)	2 (2)	6 (3)
Any adverse events leading to study	7 (5)	12 (4)	1 (1)	13 (5)
Adverse events leading to death	0	0	0	0

De flesta händelser ansågs vara milda eller måttliga.
Andelen allvarliga biverkningar var generellt låg och liknande mellan etrasimod- och placebogrupperna.
Antalet patienter som avbröt studien på grund av biverkningar var generellt lågt och liknande mellan etrasimod- och placebogrupperna.
De mest rapporterade biverkningarna inkluderade anemi, huvudvärk och förvärring av UC.

Placebo-controlled cohort: Patients who received either placebo or VELSIPITY as part of 1 phase 2 study (VELSIPITY 1 mg or 2 mg for 12 weeks; NCT02447302) or 2 phase 3 studies (VELSIPITY 2 mg for 12 weeks or 52 weeks; NCT03945188 and NCT03996369).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).¹

1 event of death occurred in the all UC cohort; this was a serious AE of neuroendocrine tumor resulting in death that was assessed by the investigator as not related to study treatment.¹

No events of posterior reversible encephalopathy syndrome were reported.¹

References:

Vermeire S, Peyrin-Biroulet L, Panés J, et al. Etrasimod for the treatment of ulcerative colitis: up to 2.5 years of pooled safety data from global clinical trials. J Crohns Colitis. 2023;17(suppl 1):i619-i620. Abstracts of the 18th Congress of ECCO 2023—European Crohn’s and Colitis Organisation; March 1-4, 2023; Copenhagen, Denmark. Abstract ID: P490. jjac190.0620. https://academic.oup.com/ecco-jcc/article/17/ Supplement_1/i619/7009929. Accessed December 18, 2023.

Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.

Cardiac and ocular adverse events (AEs) with VELSIPITY^1,2

Sammanfattning av AEs av särskilt intresse inom ELEVATE UC 52 och UC 12

	ELEVATE UC 52		ELEVATE UC 12
Patients, n (%)	Placebo (n-144)	Etrasimod (n-289)	Placebo (n-116)	Etrasimod (n-238)
Serious infections	5(3)	3(1)	0	0
Herpes zoster	0	2 (1)	2 (2)	0
Opportunist icinfections	1 (1)	0	0	1 (<1)
Hypertension	1 (1)	8 (3)	1 (1)	3 (1)
Sinus bradycardia	0	0	0	4 (2)
Bradycardia	0	4 (1)	0	1 (<1)
Atrioventricular block, first degree*	0	1 (<1)	0	1 (<1)
Atrioventricular block, second degree (Mobitz I)*	0	1 (<1)	0	0
Macular oedema, n (%)	0	1 (<1)	1 (1)	1 (<1)

Transient, first-dose decreases in heart rate or AV conduction delays may occur^1,2

Initiation of VELSIPITY may result in a transient decrease in heart rate and AV conduction delays
On day 1, after the first dose of VELSIPITY, the greatest mean decrease from baseline in heart rate was observed at hour 2 or hour 3 post dose
Patients who experienced bradycardia were generally asymptomatic
Few patients experienced symptoms, such as dizziness, and these symptoms resolved without intervention

All macular edema events were resolved in the phase 3 trials^1,2

Risk of macular edema is higher if patients have diabetes, uveitis, or certain other eye problems
An eye exam of the fundus, including the macula, is recommended near the start of treatment in all patients and at any time if there is any change in vision while taking VELSIPITY
Patients who present with visual symptoms of macular edema should be evaluated; if confirmed, treatment with etrasimod should be discontinued

Cardiac contraindications¹

VELSIPITY is contraindicated in patients with certain preexisting cardiac abnormalities^*

The information above pertains to cardiac and ocular AEs associated with required baseline assessments. Please see Summary of Product Characteristics for all adverse events.

Patients in the last 6 months who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or New York Heart Association (NYHA) class III or class IV heart failure. Patients with history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker.1

VELSIPITY (etrasimod) Summary of Product Characteristics. Brussels, Belgium: Pfizer Europe; February 2024.

Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.

Safety

Cardiac and Ocular ARs

See the incidence of these events in ELEVATE UC 52 and ELEVATE UC 12.

SEE ARs

PP-V1A-GLB-0013 February 2024

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