Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea

NCT04499495 | Completed

• 1 other identifier: 000388
• Study Type: observational
• Target: 11,385
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity. 5-Aminosalicylic acid (5-ASA), immunomodulator, or biologics, etc are prescribed to treat UC, however 5-ASA is generally considered the first-line therapy. The recent UC treatment guideline in Korea and the United States/ European Union (US/EU) have recommended higher daily dose for patients with mild or moderate severity than the previous guidelines since 2017. Accordingly, it is assumed that the average daily treatment dose of 5-ASA would increase in patients who were initially diagnosed with UC in real-world clinical practice in Korea. However, there are not many studies evaluating the treatment patterns and health outcomes of 5-ASA based on the recent treatment guideline in South Korea. This study, hence, aims to investigate the impact of changes in daily dose of 5-ASA on the treatment patterns and health outcomes such as recurrence rate, hospitalization rate, and surgery rate in real world practice using Health Insurance Review and Assessment (HIRA) claims database.

Conditions

Ulcerative Colitis

Keywords

Mesalamine; Retrospective; 5-aminosalicylic acid; Prescription pattern

Outcome Measures

Primary Outcomes (2)

• Changes in initial 3-months average daily dose of 5-ASA

  Initial average daily dose is defined as the average dose of 5-ASA prescribed over the 3-month period following the first prescription date of 5-ASA (i.e. prescription index date). Dose of 5-ASA includes those of mesalamine, sulfasalazine, and balsalazide. The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy. Oral and rectal combination therapy will be identified when the percentage of rectal therapy over the 3-months following the first prescription date of 5-ASA is more than 25%. For oral and rectal combination therapy, only oral formulation will be considered to calculate the dose of a combination therapy. The average daily dose of 5-ASA will be categorized as: Oral mono high dose (\>=3g), oral mono standard dose (2-3g), oral mono low dose (\<2g); Oral combination high dose (\>=3g), oral combination standard dose (2-3g); oral combination low dose (\<2g); Rectal monotherapy.

  From prescription index date up to 3 months

• Prescription patterns of 5-ASA

  The prescription patterns will be categorized into: oral monotherapy; rectal monotherapy; oral and rectal combination therapy based on the exposure medications (mesalazine, sulfasalazine, and/or balsalazide) prescribed.

  From 01 January 2009 to 31 March 2019

Secondary Outcomes (3)

• Non-response to 5-ASA by the average daily dose of 5-ASA

  From 01 January 2009 to 31 March 2019

• Ulcerative Colitis Related hospitalization by the average daily dose of 5-ASA

  From 01 January 2009 to 31 March 2019

• Ulcerative Colitis related surgery by the average daily dose of 5-ASA

  From 01 January 2009 to 31 March 2019

Interventions

PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA) OTHER

The 5-ASAs of interest in the study are mesalazine (5-ASA); sulfasalazine (5-ASA+sulfapyridine); and balsalazide (5-ASA) and will be grouped together as 5-ASA. For sulfasalazine and balsalazide, the equivalent dose to 5-ASA will be calculated as: balsalazide 6.75g is equivalent to 2.4g of mesalamine; and Sulfasalazine 4g is equivalent to 1.6g of mesalamine. The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from Korean HIRA claim database according to the inclusion/exclusion criteria. The Korean patients who were initially diagnosed with UC from 01 January 2009 to 30 June 2018 will be included in this study.

You may qualify if:

• Patients who were diagnosed with UC during the index period.
• Patients who had at least two claims of 5-ASA (sulfasalazine, balsalazide, mesalamine) during the index period.
• Patients who underwent at least one endoscopy within a 3-month period prior to the index date (i.e. the first date of diagnosis with UC).
• Defined as a claim with relevant endoscopy procedure code.
• Include the upper gastrointestinal endoscopy, colonoscopy, sigmoidoscopy, which are identified using the procedure code.
• Patients who were treated with 5-ASA continuously for at least 1-month after the index date.
• Defined as those who were treated with 5-ASA for more than 30 days within 6-month after the index date (i.e. the first date of diagnosis with UC).

You may not qualify if:

• Patients less than 15 years old as of the index date (\<15 years old).
• Patients who were treated with 5-ASA during the baseline period (i.e. 12-month prior to the index date).
• Patients who were diagnosed with UC during the baseline period.
• Patients who received steroids, immunosuppressants, or biologics during the baseline period.
• Steroid includes both oral medication and intravenous (IV) injection. The analysis will include the moderate- to high-dose of cumulative steroid use, which is defined as \>=30mg of prednisolone, \>= 50mg of methylprednisolone, or \>=50mg of hydrocortisone.
• Immunosuppressants is defined as at least one claim with Azathioprine or 6-Mercaptopurine.
• Biologics is defined as at least one claim with Infliximab, Adalimumab, Ustekinumab, Vedolizumab, Golimumab, or Tofacitinib.
• Patients who were diagnosed with Crohn's disease at any time in the overall study period.
• Defined as a claim with relevant Crohn's disease code recorded as primary diagnosis during the baseline period or follow-up period (i.e. entire study period).

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Location

Related Publications (1)

• Park SJ, Park SW, Cheon JH. Ten-Year Trend in 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients with Ulcerative Colitis: An Analysis of Korean Health Insurance Data. Dig Dis Sci. 2025 Dec 23. doi: 10.1007/s10620-025-09629-0. Online ahead of print.

  PMID: 41436897 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: October 25, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)