Early Experience with Etrasimod in Ulcerative Colitis Patients: an Observational Study in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  VELSIPITY
• Study drug International non-proprietary name (INN) or common name:
  ETRASIMOD
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AE05) etrasimod

  etrasimod
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Short description of the study population:
  The population under study will be US patients diagnosed with UC and initiating etrasimod from its marketing authorization on October, 13, 2023, to the end of study period.; Inclusion criteria:; Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:; 1. Patients who have initiated etrasimod, defined by a filled pharmacy claim ; 2. Patients with at least ≥1 inpatient or outpatient claim with evidence of UC diagnosis in medical claims using ICD-10-CM codes: K51.x on or prior to index date; 3. Patients aged ≥ 18 years at index date; 4. Data availability ≥ 12 months prior to index date; ; Exclusion Criteria; Patients meeting any of the following criteria will not be included in the study:; 1. Patients with medical claims with diagnosis code(s) corresponding to Crohn’s disease (CD) during pre-index period or index date; 2. Patients with medical claims with procedure code(s) corresponding to colectomy during pre-index period or index date; 3. Any co-prescription with select immunomodulators (methotrexate, tacrolimus, cyclosporin, thiopurine) or advanced therapies for UC (biologics, anti-TNFs, interleukin 12 and 23, anti-integrin, small molecules such as Janus kinase inhibitors [JAKi], or with any other S1P receptor modulator) on index date;
• Age groups:
  • Adult and elderly population (≥18 years)
• Estimated number of subjects:
  800

Study design details

• Study design:
  The study cohort will be defined as UC patients initiating etrasimod from its marketing authorization. For the secondary objectives, patients with closed claims will be followed for up to 12 months after the index date or to the end of their continuous enrollment, whichever comes first.
• Main study objective:
  Primary Objective ; 1. To describe the baseline demographic characteristics, comorbidities, disease and treatment characteristics of patients with UC who initiated treatment with etrasimod.; ; Secondary Objectives; 1. To describe the treatment patterns of etrasimod (adherence and persistence) among patients with UC within 12 months of etrasimod initiation. ; 2. To describe corticosteroid use among patients with UC within 12 months of etrasimod initiation. ; 3. To describe the change in level of fecal calprotectin in patients with UC, from baseline through 12 months of etrasimod initiation.;
• Setting:
  The population under study will be US patients diagnosed with UC and initiating etrasimod from its marketing authorization on October, 13, 2023 to the end of study period.; This study will use existing data from large US claims database, which captures claims data from 300 million US people sufficiently representative of the US population with insurance coverage. Data from the eligible patients available in the datasource, i.e from 2015 to latest date of data availability will be used in the study, to document baseline characteristics and assess endpoints of interest.; The US UC population will be identified from the database, by considering all patients with an ICD-10 diagnosis code equal to K51.x (UC) between 2015 to the end of study period.
• Comparators:
  No comparison
• Outcomes:
  Primary endpoint is baseline characteristics of patients. ; Secondary endpoints are adherence, measured by proportion of days covered method, persistence (delay until etrasimod discontinuation), the use of corticosteroids and change in level of fecal calprotectin, within 12 months of etrasimod initiation.
• Data analysis plan:
  All analyses defined in detail in the statistical anlaytical plan (SAP), which will be the reference document.; Primary objective (baseline characteristics) will be analyzed among patients who have met the selection criteria (eligible population). For the analysis of secondary objectives, analyses will be performed on patients with closed index etrasimod claim and continuous enrollment after the index date. Specific windows of minimal continuous enrollment will be defined in the SAP for each analysis.