Trial Design | Efficacy | 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

Trial Design

Baseline
Characteristics

Eligibility Criteria

Efficacy
Endpoints

VELSIPITY was studied across 2 Phase III trials in
patients aged 16–80 years with moderately to
severely active UC²

ELEVATE UC 52 and ELEVATE UC 12 were randomized, multicenter, double-blind, placebo-controlled trials²

Co-primary endpoints: Clinical remission at week 12 (ELEVATE UC 52 and ELEVATE UC 12) and week 52 (ELEVATE UC 52)^†2

Primary efficacy analysis was done in patients with a baseline mMS‡ of 5 to 9 (ELEVATE UC 52: n=409; ELEVATE UC 12: n=334)²

ELEVATE UC 52 used a treat through trial design, which may more closely represent real-world
practice.^2-4

Learn about a treat-through trial design

Treat-through trial design may more closely represent clinical practice as it reflects outcomes for all patients who started therapy, not just induction responders ^2,3

TREAT-THROUGH TRIAL DESIGN⁴

This is not representative of all treat-through trial designs.

Includes non-responders or patients who respond late to treatment and may more
closely represent real-world practice^2,3,5

ELEVATE UC 52 was a 52-week, Phase III treat-through trial of an oral therapy in UC⁴

In the ELEVATE UC 52 treat-through trial, patients who do not respond by Week 12 are included in the Week 52 analysis, in contrast to being removed as in a responder re-
randomised trial^2,4
- This design may more closely reflect clinical practice, as it allows for evaluation of response to treatment beyond the standard induction timepoint^2,3

Includes only responders to treatment⁵

In typical UC re-randomised trials, only induction responders are re-randomised for
maintenance treatment; therefore, maintenance data only reflect potential outcomes
for early responders, which may need to be considered when reviewing efficacy data⁵

Cross-trial comparisons should be evaluated cautiously, as relative efficacy can only be
definitively determined by well-designed, head-to-head, randomised trials.⁴

R – randomised; RR – re-randomised; UC – ulcerative colitis.

References:

1. VELSIPITY Summary of Product Characteristics.
2. Atreya R and Neurath MF. Lancet 2023;401(10383):1132-1133.
3. Sands BE et al. J Crohns Colitis 2019;13(9):1217-1226.
4. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171.
5. Ghosh S et al. Inflamm Bowel Dis 2016;22(11):2711-2723.

*In ELEVATE UC 52, patients whose disease had not improved or had worsened vs baseline (per investigator judgement), could discontinue treatment and, if objective disease worsening criteria were met (having either or both RB subscore ≥2 or an RB
subscore and an SF subscore ≥4 at 2 time points ≥7 and ≤14 days apart), enrol in the OLE. In ELEVATE UC 12, at the end of
Week 12, patients could enrol in the OLE. In both trials, patients who did not enrol in the OLE entered a 4-week follow-up
period, with visits at Week 2 and at Week 4.²
† Clinical remission was defined as a composite of SF subscore = 0 (or SF subscore = 1 with a ≥1-point decrease from
baseline), RB subscore = 0, and endoscopic subscore of 1 or less by independent, centrally read assessment (without
friability).²
‡ The modified Mayo score (an mMS of 0 to 9) consists of SF (0 to 3), RB (0 to 3), and findings on a centrally read endoscopy
score (0 to 3)^.2

Clinical Remission

Read about clinical remission seen in patients on VELSIPITY.

SEE CLINICAL REMISSION

mMS – modified Mayo score; OLE – open-label extension; R – randomisation; RB – rectal bleeding; SF – stool frequency; UC – ulcerative colitis.

References:

VELSIPITY Summary of Product Characteristics

Sandborn WJ et al. Lancet 2023;401(10383):1159 1171

Atreya R and Neurath MF. Lancet 2023;401(10383):1132 1133.

Ghosh S et al. Inflamm Bowel Dis 2016;22(11):2711 2723.

Baseline patient characteristics

VELSIPITY was studied in a patient population with a history of inadequate
response, loss of response, or intolerance to one or more of the following treatment
options: Oral 5-ASAs, corticosteroids, thiopurines, JAKis or a biologic (e.g. TNF
blocker, anti integrin, anti interleukins 12/23)^2,3

Scroll left to view table

Adapted from Sandborn WJ et al. 2023.2 List is not exhaustive.

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*As reported by investigators during the screening period.²

Read about clinical remission seen in patients on VELSIPITY.

Clinical Remission

SEE CLINICAL REMISSION

5-ASA – aminosalicylate; JAKi – janus kinase inhibitor; mMS – modified Mayo score; SD – standard deviation; TNF – tumour necrosis factor; UC – ulcerative colitis.

References:

VELSIPITY Summary of Product Characteristics.

Sandborn WJ et al. Lancet 2023;401(10383):1159-1171.

Sandborn WJ et al. Lancet 2023;401(10383):1159-1171 (supplementary appendix).

Peyrin Biroulet L et al. Abstract for the United European Gastroenterology Week 2023, Copenhagen, Denmark.

Select inclusion and exclusion criteria for ELEVATE UC 52 and ELEVATE UC 12^2,3

Select inclusion criteria:

Patients 16 to 80 years of age with moderately to severely active ulcerative colitis (UC)
and a documented history of inadequate response, loss of response, or an intolerance to
≥1 of the following treatment options: Oral 5-ASAs, corticosteroids, thiopurines, JAKis or
a biologic (e.g. TNF blocker, anti-integrin, anti-interleukins 12/23); diagnosis of
moderately to severely active UC was confirmed by endoscopy with ≥10 cm rectal
involvement and on the basis of an mMS of 4 to 9 with a centrally read endoscopic
subscore ≥2 and a rectal bleeding subscore ≥1

Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enrol in both trials, with enrolment capped at 15% of total
population

Patients were allowed to receive concomitant treatment for UC before trial screening, provided they were on:

Stable doses of oral 5-ASAs ≥2 weeks before

Stable doses of corticosteroids (prednisone [≤20 mg/day], budesonide [≤9 mg/day], or equivalent) 4 weeks immediately before
- Investigators were directed to taper corticosteroids in ELEVATE UC 52 after the Week 12 assessment

Select exclusion criteria:

Previous treatment with ≥3 biologic agents or ≥2 biologics plus a JAKi

A high risk of requiring a colectomy in the next 3 months (per investigator)

A clinically relevant cardiac condition (a history of myocardial infarction, unstable angina,
stroke, or second-degree or third-degree atrioventricular block)

A history of opportunistic infections

A history of macular oedema or retinopathy

Pregnancy or lactation

Concomitant treatment with immunomodulators, biologic therapies, rectal 5-ASAs or
rectal corticosteroids¹

^{For full details on inclusion and exclusion criteria, please consult the supplementary appendix of the clinical trial paper.}

Clinical Remission

Read about clinical remission seen in patients on VELSIPITY.

SEE CLINICAL REMISSION

5-ASA – aminosalicylate; JAKi – janus kinase inhibitor; mMS – modified Mayo score; TNF – tumour necrosis factor;
UC – ulcerative colitis.

References:

VELSIPITY Summary of Product Characteristics.

Sandborn WJ et al. Lancet 2023;401(10383):1159-1171.

Sandborn WJ et al. Lancet 2023;401(10383):1159-1171 (supplementary appendix).

VELSIPITY met all primary and key secondary endpoints²

Trial endpoints were modelled after STRIDE II guidelines and designed to support use after conventional therapy^2,3

Scroll left to view table

Primary and key secondary endpoints were controlled for multiplicity via parallel gatekeeping procedures that preserved the type I error rate at 5%²

Clinical Remission

Read about clinical remission seen in patients on VELSIPITY.

SEE CLINICAL REMISSION

ES=endoscopic subscore; mMS=modified Mayo score; NA=not applicable; RB=rectal bleeding; SF - stool frequency; STRIDE=Selecting Therapeutic Targets in Inflammatory Bowel Disease.

References:

VELSIPITY Summary of Product Characteristics.

Sandborn WJ et al. Lancet 2023;401(10383):1159 1171

Turner D et al. Gastroenterology 2021;160(5):1570 1583.

Efficacy

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